Trial Outcomes & Findings for Losartan Effects on Emphysema Progression (NCT NCT02696564)
NCT ID: NCT02696564
Last Updated: 2022-06-01
Results Overview
change in percentage of voxels with density less than -950 Hounsfield Units
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
220 participants
Primary outcome timeframe
48 weeks
Results posted on
2022-06-01
Participant Flow
2,779 individuals were screened for this study; of those, 2,028 were determined to be ineligible, and 531 declined to participate.
220 individuals were randomized into the study.
Participant milestones
| Measure |
Losartan
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
108
|
112
|
|
Overall Study
COMPLETED
|
94
|
99
|
|
Overall Study
NOT COMPLETED
|
14
|
13
|
Reasons for withdrawal
| Measure |
Losartan
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Overall Study
Death
|
1
|
2
|
|
Overall Study
Withdrawal by Subject
|
3
|
2
|
|
Overall Study
Lost to Follow-up
|
3
|
3
|
|
Overall Study
Missed final HRCT scan due to coronavirus disease pandemic
|
3
|
1
|
|
Overall Study
Baseline and final high-resolution computed tomography (HRCT) scans conducted on different scanners
|
2
|
2
|
|
Overall Study
High-resolution computed tomography (HRCT) scan conducted on unknown scanner
|
1
|
1
|
|
Overall Study
Participant diagnosed with lung cancer
|
1
|
0
|
|
Overall Study
Incorrect kernel used in high-resolution computed tomography (HRCT) scan
|
0
|
2
|
Baseline Characteristics
Pre-bronchodilator spirometry results were not available for 11 participants in the Losartan group and 8 participants in the Placebo group.
Baseline characteristics by cohort
| Measure |
Losartan
n=108 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=112 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
Total
n=220 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
66 years
n=108 Participants
|
65 years
n=112 Participants
|
65 years
n=220 Participants
|
|
Sex: Female, Male
Female
|
47 Participants
n=108 Participants
|
46 Participants
n=112 Participants
|
93 Participants
n=220 Participants
|
|
Sex: Female, Male
Male
|
61 Participants
n=108 Participants
|
66 Participants
n=112 Participants
|
127 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
19 Participants
n=108 Participants
|
23 Participants
n=112 Participants
|
42 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
White
|
88 Participants
n=108 Participants
|
88 Participants
n=112 Participants
|
176 Participants
n=220 Participants
|
|
Race/Ethnicity, Customized
Other
|
1 Participants
n=108 Participants
|
1 Participants
n=112 Participants
|
2 Participants
n=220 Participants
|
|
Region of Enrollment
United States
|
108 participants
n=108 Participants
|
112 participants
n=112 Participants
|
220 participants
n=220 Participants
|
|
Body Mass Index (BMI)
|
27 kg/m^2
n=108 Participants
|
26 kg/m^2
n=112 Participants
|
26 kg/m^2
n=220 Participants
|
|
Current smokers (past month)
|
26 Participants
n=108 Participants
|
26 Participants
n=112 Participants
|
52 Participants
n=220 Participants
|
|
Smoking history
|
46 Pack-years
n=108 Participants
|
42 Pack-years
n=112 Participants
|
44 Pack-years
n=220 Participants
|
|
Spirometry percent predicted
Pre-bronchodilator % predicted FEV1
|
43 Percent predicted
n=97 Participants • Pre-bronchodilator spirometry results were not available for 11 participants in the Losartan group and 8 participants in the Placebo group.
|
43 Percent predicted
n=104 Participants • Pre-bronchodilator spirometry results were not available for 11 participants in the Losartan group and 8 participants in the Placebo group.
|
43 Percent predicted
n=201 Participants • Pre-bronchodilator spirometry results were not available for 11 participants in the Losartan group and 8 participants in the Placebo group.
|
|
Spirometry percent predicted
Post-bronchodilator % predicted FEV1
|
48 Percent predicted
n=108 Participants • Pre-bronchodilator spirometry results were not available for 11 participants in the Losartan group and 8 participants in the Placebo group.
|
48 Percent predicted
n=112 Participants • Pre-bronchodilator spirometry results were not available for 11 participants in the Losartan group and 8 participants in the Placebo group.
|
48 Percent predicted
n=220 Participants • Pre-bronchodilator spirometry results were not available for 11 participants in the Losartan group and 8 participants in the Placebo group.
|
|
Spirometry pre-bronchodilator FEV1
|
1.1 Liters
n=97 Participants • Pre-bronchodilator spirometry results were not available for 11 individuals from the Losartan group and 8 individuals from the Placebo group.
|
1.1 Liters
n=104 Participants • Pre-bronchodilator spirometry results were not available for 11 individuals from the Losartan group and 8 individuals from the Placebo group.
|
1.1 Liters
n=201 Participants • Pre-bronchodilator spirometry results were not available for 11 individuals from the Losartan group and 8 individuals from the Placebo group.
|
|
Sitting Blood Pressure
Systolic
|
125 Millimeters of mercury (mmHg)
n=108 Participants
|
123 Millimeters of mercury (mmHg)
n=112 Participants
|
124 Millimeters of mercury (mmHg)
n=220 Participants
|
|
Sitting Blood Pressure
Diastolic
|
77 Millimeters of mercury (mmHg)
n=108 Participants
|
75 Millimeters of mercury (mmHg)
n=112 Participants
|
76 Millimeters of mercury (mmHg)
n=220 Participants
|
|
St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (COPD) score
Total
|
42 units on a scale
n=108 Participants
|
40 units on a scale
n=112 Participants
|
42 units on a scale
n=220 Participants
|
|
St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (COPD) score
Symptoms
|
55 units on a scale
n=108 Participants
|
56 units on a scale
n=112 Participants
|
55 units on a scale
n=220 Participants
|
|
St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (COPD) score
Activity
|
59 units on a scale
n=108 Participants
|
59 units on a scale
n=112 Participants
|
59 units on a scale
n=220 Participants
|
|
St. George's Respiratory Questionnaire for chronic obstructive pulmonary disease (COPD) score
Impact
|
28 units on a scale
n=108 Participants
|
26 units on a scale
n=112 Participants
|
27 units on a scale
n=220 Participants
|
|
COPD Assessment Test
|
17 units on a scale
n=108 Participants
|
16 units on a scale
n=112 Participants
|
17 units on a scale
n=220 Participants
|
|
COPD Assessment Test impact level
Mild
|
21 Participants
n=108 Participants
|
26 Participants
n=112 Participants
|
47 Participants
n=220 Participants
|
|
COPD Assessment Test impact level
Moderate
|
52 Participants
n=108 Participants
|
45 Participants
n=112 Participants
|
97 Participants
n=220 Participants
|
|
COPD Assessment Test impact level
Severe
|
35 Participants
n=108 Participants
|
33 Participants
n=112 Participants
|
68 Participants
n=220 Participants
|
|
COPD Assessment Test impact level
Very severe
|
0 Participants
n=108 Participants
|
8 Participants
n=112 Participants
|
8 Participants
n=220 Participants
|
|
Modified Medical Research Council dyspnea scale
|
1 units on a scale
n=108 Participants
|
1 units on a scale
n=112 Participants
|
1 units on a scale
n=220 Participants
|
|
PROMIS Physical Function-20a
|
40 units on a scale
n=108 Participants
|
40 units on a scale
n=112 Participants
|
40 units on a scale
n=220 Participants
|
PRIMARY outcome
Timeframe: 48 weekschange in percentage of voxels with density less than -950 Hounsfield Units
Outcome measures
| Measure |
Losartan
n=94 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=99 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Change in Mean pct950
|
1.35 percentage of voxels
Interval 0.67 to 2.02
|
0.66 percentage of voxels
Interval 0.09 to 1.23
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Pre-bronchodilator results were not available at the baseline and/or final visit for 57 participants in the Losartan group and 56 participants in the placebo group. This was due in part to the elimination of all non-medically necessary spirometry testing during the COVID-19 pandemic.
Change from the first visit to the final visit in a spirometry (breathing test) measure: forced expiratory volume in one second (FEV1). The test is administered without the participant taking any bronchodilator medication. The FEV1 is compared to standard predicted values in the US population for each individual based on their height, gender, and ethnic group; the result is given as percent of predicted value.
Outcome measures
| Measure |
Losartan
n=51 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=56 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Change From Baseline in Pre-bronchodilator FEV1 Percent Predicted
|
-0.99 percentage of predicted value
Interval -3.18 to 1.2
|
-0.54 percentage of predicted value
Interval -2.47 to 1.38
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Post-bronchodilator results were not available at the baseline and/or final visit for 35 participants in the Losartan group and 39 participants in the placebo group. This was due in part to the elimination of all non-medically necessary spirometry testing during the COVID-19 pandemic.
Change from the first visit to the final visit in a spirometry (breathing test) measure: forced expiratory volume in one second (FEV1). This test is performed after the participant is given bronchodilator medications. The FEV1 is compared to standard predicted values in the US population for each individual based on their height, gender, and ethnic group; the result is given as percent of predicted value.
Outcome measures
| Measure |
Losartan
n=73 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=73 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Change From Baseline in Post-bronchodilator FEV1 Percent Predicted
|
-2.60 percentage of predicted value
Interval -4.22 to -0.98
|
-2.37 percentage of predicted value
Interval -3.71 to -1.03
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: CAT results were not available at the baseline and/or final visit for 9 participants in the Losartan group and 8 participants in the placebo group.
Change from the first visit to the final visit in the participant's COPD Assessment Test (CAT) score. The CAT is an 8-item questionnaire assessing the impact of COPD on health status. CAT scores range from 0 to 40, with higher scores indicating a more severe impact of COPD on a patient's life.
Outcome measures
| Measure |
Losartan
n=99 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=104 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Change From Baseline in CAT Score
|
-0.18 score on a scale
Interval -1.21 to 0.85
|
0.03 score on a scale
Interval -1.04 to 1.09
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Total SGRQ results were not available at the baseline and/or final visit for 9 participants in the Losartan group and 9 participants in the placebo group.
Change from the first visit to the final visit in participants' score on the St George's Respiratory Questionnaire - COPD. The St George's Respiratory Questionnaire for COPD patients (SGRQ-C) is a 40-item questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with COPD. The SGRQ-C includes three categories: Symptoms (frequency and severity), Activities caused or limited by breathlessness, and Impacts on social and psychological functioning caused by airways disease. The total score and scores for each category range from 0 to 100, with higher scores indicating more limitations.
Outcome measures
| Measure |
Losartan
n=99 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=103 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Change From Baseline in SGRQ Score: Total
|
-1.31 score on a scale
Interval -3.15 to 0.52
|
1.20 score on a scale
Interval -0.68 to 3.08
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: SGRQ results were not available at the baseline and/or final visit for 9 participants in the Losartan group and 9 participants in the placebo group.
Change from the first visit to the final visit in participants' scores on the symptom-related questions on the St Georges Respiratory Questionnaire-COPD. The St George's Respiratory Questionnaire for COPD patients (SGRQ-C) is a 40-item questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with COPD. The SGRQ-C includes three categories: Symptoms (frequency and severity), Activities caused or limited by breathlessness, and Impacts on social and psychological functioning caused by airways disease. The total score and scores for each category range from 0 to 100, with higher scores indicating more limitations.
Outcome measures
| Measure |
Losartan
n=99 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=103 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Change From Baseline in SGRQ Score: Symptoms
|
-6.19 score on a scale
Interval -8.76 to -3.62
|
-1.78 score on a scale
Interval -4.04 to 0.49
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: SGRQ results were not available at the baseline and/or final visit for 9 participants in the Losartan group and 9 participants in the placebo group.
Change from the first visit to the final visit in participants' scores on the activity-related questions on the St Georges Respiratory Questionnaire-COPD. The St George's Respiratory Questionnaire for COPD patients (SGRQ-C) is a 40-item questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with COPD. The SGRQ-C includes three categories: Symptoms (frequency and severity), Activities caused or limited by breathlessness, and Impacts on social and psychological functioning caused by airways disease. The total score and scores for each category range from 0 to 100, with higher scores indicating more limitations.
Outcome measures
| Measure |
Losartan
n=99 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=103 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Change From Baseline in SGRQ Score: Activity
|
-0.66 score on a scale
Interval -3.22 to 1.91
|
2.45 score on a scale
Interval -0.1 to 5.0
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: SGRQ results were not available at the baseline and/or final visit for 9 participants in the Losartan group and 9 participants in the placebo group.
Change from the first visit to the final visit in participants' scores on the impact-related questions on the St Georges Respiratory Questionnaire-COPD. The St George's Respiratory Questionnaire for COPD patients (SGRQ-C) is a 40-item questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with COPD. The SGRQ-C includes three categories: Symptoms (frequency and severity), Activities caused or limited by breathlessness, and Impacts on social and psychological functioning caused by airways disease. The total score and scores for each category range from 0 to 100, with higher scores indicating more limitations.
Outcome measures
| Measure |
Losartan
n=99 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=103 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Change in SGRQ Score: Impact
|
-0.25 score on a scale
Interval -2.46 to 1.96
|
1.35 score on a scale
Interval -0.67 to 3.38
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: mMRC dyspnea scale results were not available at the baseline and/or final visit for 9 participants in the Losartan group and 9 participants in the placebo group.
Change from the first visit to the final visit in participants' scores on the modified Medical Research Council dyspnea scale. The modified Medical Research Council dyspnea scale (mMRC) is a self-rating tool to measure how much breathlessness affects someone's day to day activities. Scores are between 0 and 4, with higher scores indicating more severe breathlessness.
Outcome measures
| Measure |
Losartan
n=99 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=103 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Change From Baseline in mMRC Dyspnea Scale
|
0.01 score on a scale
Interval -0.15 to 0.16
|
0.11 score on a scale
Interval -0.03 to 0.26
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: PROMIS-20a results were not available at the baseline and/or final visit for 9 participants in the Losartan group and 10 participants in the placebo group.
Change from the first visit to the final visit in participants' scores on the Patient-Reported Outcome Measures Information System (PROMIS) Physical Function assessment. The Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function Short Form 20a is a 20-item questionnaire used to indicate a patient's ability to perform activities of daily living, such as bathing, dressing, and commuting. Raw scores from this questionnaire are compared to a reference population to create a "T-score". The general US population is the reference population. In this T-score metric, 50 indicates the population mean with a standard deviation of 10. Higher scores mean better outcomes (more ability to do activities of daily living)
Outcome measures
| Measure |
Losartan
n=99 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=102 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Change From Baseline in PROMIS-20a T-score
|
0.00 score on a scale
Interval -0.59 to 0.59
|
-1.04 score on a scale
Interval -1.62 to -0.45
|
POST_HOC outcome
Timeframe: 48 weeksPopulation: The analysis population consists of the number of participants who reported at least one exacerbation in each treatment group. Two participants in the losartan treatment group did not report any COPD exacerbations during the study.
This measure assessed the number of exacerbations of chronic obstructive pulmonary disease in both the losartan and placebo treatment groups. Participants were asked about current and past exacerbations during each study visit. Exacerbations were defined as 2 or more worsening COPD symptoms lasting 3 or more consecutive days that required a new prescribed treatment. Each exacerbation was further classified as "mild" (requiring only a change in existing COPD medications),"moderate" (requiring a new prescription for a steroid and/or antibiotic), or "severe" (requiring a hospitalization for COPD symptoms).
Outcome measures
| Measure |
Losartan
n=106 Participants
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=112 Participants
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Number of COPD Exacerbations by Severity and Treatment Assignment
Moderate exacerbation
|
41 exacerbation events
|
47 exacerbation events
|
|
Number of COPD Exacerbations by Severity and Treatment Assignment
Severe exacerbation
|
7 exacerbation events
|
21 exacerbation events
|
|
Number of COPD Exacerbations by Severity and Treatment Assignment
Mild exacerbation
|
3 exacerbation events
|
4 exacerbation events
|
Adverse Events
Losartan
Serious events: 18 serious events
Other events: 106 other events
Deaths: 1 deaths
Placebo
Serious events: 25 serious events
Other events: 112 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
Losartan
n=108 participants at risk
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=112 participants at risk
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
COPD Exacerbation
|
5.6%
6/108 • Number of events 6 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
13.4%
15/112 • Number of events 19 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Bronchitis
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
2.7%
3/112 • Number of events 3 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory failure secondary to end stage COPD
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Collapsed lung
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Radiation pneumonitis
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Hypercapnic respiratory failure
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Shortness of breath
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Breast cancer
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lung cancer
|
1.9%
2/108 • Number of events 2 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lymphoma
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Cardiac disorders
Myocardial infarction
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Cardiac disorders
Coronary artery disease
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
2.7%
3/112 • Number of events 3 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Musculoskeletal and connective tissue disorders
Total knee replacement
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Musculoskeletal and connective tissue disorders
Spinal fusion revision
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Injury, poisoning and procedural complications
Falls
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Injury, poisoning and procedural complications
Motor vehicle accident
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Infections and infestations
Influenza
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Infections and infestations
Sepsis
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Gastrointestinal disorders
Gastrointestinal bleeding
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
1.8%
2/112 • Number of events 2 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
General disorders
Dehydration
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.93%
1/108 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.00%
0/112 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Nervous system disorders
Near syncope
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Musculoskeletal and connective tissue disorders
Pseudogout
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Psychiatric disorders
Panic attack
|
0.00%
0/108 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
0.89%
1/112 • Number of events 1 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
Other adverse events
| Measure |
Losartan
n=108 participants at risk
At randomization participants will start with a dose of 50mg (one capsule) once a day for 2 weeks. If this dose is well tolerated and systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 100 mg (2 capsules) once a day for the remaining 46 weeks.
Losartan: 50mg once per day for two weeks,followed by 100mg once per day for 46 weeks if increased dose tolerated
|
Placebo
n=112 participants at risk
At randomization participants will start with a dose of one capsule (inactive) once a day for 2 weeks. After two weeks, if systolic BP is \>90 mm Hg and diastolic BP is \> 60 mm Hg, the dose will be increased to 2 capsules once a day for the remaining 46 weeks.
Placebo: one capsule per day for two weeks, followed by two capsules per day for 46 weeks
|
|---|---|---|
|
Cardiac disorders
Chest pain
|
8.3%
9/108 • Number of events 10 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
7.1%
8/112 • Number of events 9 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Skin and subcutaneous tissue disorders
Edema
|
7.4%
8/108 • Number of events 9 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
8.9%
10/112 • Number of events 15 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Skin and subcutaneous tissue disorders
Skin rash or hives
|
8.3%
9/108 • Number of events 9 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
6.2%
7/112 • Number of events 9 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Gastrointestinal disorders
Diarrhea
|
12.0%
13/108 • Number of events 15 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
10.7%
12/112 • Number of events 16 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Gastrointestinal disorders
Heartburn/indigestion
|
10.2%
11/108 • Number of events 17 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
21.4%
24/112 • Number of events 36 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
6.5%
7/108 • Number of events 7 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
8.9%
10/112 • Number of events 11 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.6%
33/108 • Number of events 57 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
33.9%
38/112 • Number of events 77 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Musculoskeletal and connective tissue disorders
Muscle cramps
|
25.9%
28/108 • Number of events 46 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
26.8%
30/112 • Number of events 49 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
27.8%
30/108 • Number of events 50 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
28.6%
32/112 • Number of events 63 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
17.6%
19/108 • Number of events 36 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
21.4%
24/112 • Number of events 36 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Nervous system disorders
Dizziness/lightheadedness
|
25.0%
27/108 • Number of events 34 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
14.3%
16/112 • Number of events 20 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Nervous system disorders
Headache/ head pain
|
24.1%
26/108 • Number of events 38 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
31.2%
35/112 • Number of events 52 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
General disorders
Fatigue
|
35.2%
38/108 • Number of events 71 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
36.6%
41/112 • Number of events 77 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
General disorders
Fever
|
4.6%
5/108 • Number of events 5 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
5.4%
6/112 • Number of events 6 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
General disorders
Sleep problems
|
27.8%
30/108 • Number of events 46 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
30.4%
34/112 • Number of events 65 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
General disorders
Sore throat
|
7.4%
8/108 • Number of events 9 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
16.1%
18/112 • Number of events 24 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Congestion
|
38.9%
42/108 • Number of events 73 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
42.0%
47/112 • Number of events 70 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Dry cough
|
20.4%
22/108 • Number of events 26 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
30.4%
34/112 • Number of events 57 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Mild COPD exacerbation
|
2.8%
3/108 • Number of events 3 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
3.6%
4/112 • Number of events 4 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Moderate COPD exacerbation
|
23.1%
25/108 • Number of events 41 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
25.9%
29/112 • Number of events 47 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
|
Respiratory, thoracic and mediastinal disorders
Severe COPD exacerbation
|
6.5%
7/108 • Number of events 7 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
12.5%
14/112 • Number of events 21 • Baseline up to 48 weeks
Adverse events were assessed throughout the study through regular physical exams by a study physician, symptom questionnaires and medical history review at each study visit, and blood testing at the beginning, middle, and end of the study.
|
Additional Information
Robert A. Wise, M.D.
School of Medicine, Johns Hopkins University
Phone: 410-550-0545
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place