Trial Outcomes & Findings for A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy (NCT NCT02238483)
NCT ID: NCT02238483
Last Updated: 2018-05-24
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
213 participants
Primary outcome timeframe
Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)
Results posted on
2018-05-24
Participant Flow
This was a multi-centre study conducted at 39 study centres in 6 countries: Argentina (37.7% of the patients); United States (34.4%) Peru (9%) Chile (6.6%) The Netherlands (6.1%) and South Africa (6.1%) A seasonal recruitment strategy was undertaken where patients were recruited in the fall and winter months of the geographic locality.
327 patients signed informed consent, of which 213 patients were randomised. The majority of the 114 not randomised were screening failures
Unit of analysis: Patient
Participant milestones
| Measure |
AZD7624
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
Matching placebo comparator
|
|---|---|---|
|
Overall Study
STARTED
|
108 108
|
105 105
|
|
Overall Study
COMPLETED
|
93 93
|
91 91
|
|
Overall Study
NOT COMPLETED
|
15 15
|
14 14
|
Reasons for withdrawal
| Measure |
AZD7624
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
Matching placebo comparator
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
2
|
7
|
|
Overall Study
Lost to Follow-up
|
1
|
1
|
|
Overall Study
Protocol Violation
|
1
|
2
|
|
Overall Study
Death
|
1
|
0
|
|
Overall Study
Adverse Event
|
7
|
3
|
|
Overall Study
Withdrawn due to physician decision
|
1
|
0
|
|
Overall Study
Completion status not recorded
|
1
|
1
|
|
Overall Study
Illness in family member
|
1
|
0
|
Baseline Characteristics
A Phase IIa Study to Investigate the Efficacy and Safety of AZD7624 in Chronic Obstructive Pulmonary Disease (COPD) Patients While on Maintenance Therapy
Baseline characteristics by cohort
| Measure |
AZD7624
n=107 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
Total
n=212 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
49 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
103 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
58 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Age, Continuous
|
65.4 Years
STANDARD_DEVIATION 8.73 • n=5 Participants
|
64.2 Years
STANDARD_DEVIATION 8.67 • n=7 Participants
|
64.8 Years
STANDARD_DEVIATION 8.70 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
67 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
136 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
66 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
131 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
41 Participants
n=5 Participants
|
40 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian or Alaska Native
|
3 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
85 Participants
n=5 Participants
|
88 Participants
n=7 Participants
|
173 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
12 Participants
n=5 Participants
|
11 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Time to First Moderate to Severe COPD Exacerbation or Early Drop-out Related to Worsening of COPD Symptoms
|
NA days
Interval 5.0 to
Too few events were observed in the treatment group for the estimation of median using Kaplan-Meier methodology.
Too few events were observed for the estimation of the upper limit of the full range.
|
118.0 days
Interval 4.0 to
Too few events were observed for the estimation of the upper limit of the full range.
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
For the production of summary statistics, the annual event rate per subject is calculated, and standardized per a 52-week period according to the formula described below. Annual Event Rate = No. of Events\*365.25 / (Follow-up date - Date of randomization + 1).
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs Related to Worsening of COPD Symptoms (i.e. Composite Endpoint, ExDo)
|
2.16 Events / year
Standard Error 0.80
|
1.62 Events / year
Standard Error 0.63
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Time to First Event of Moderate or Severe COPD Exacerbations or Early Drop-out (Including Drop-outs Due to Any Cause)
|
NA days
Interval 5.0 to
Too few events were observed in the treatment group for the estimation of median using Kaplan-Meier methodology.
Too few events were observed for the estimation of the upper limit of the full range.
|
118.0 days
Interval 4.0 to
Too few events were observed for the estimation of the upper limit of the full range.
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
For the production of summary statistics, the annual event rate per subject is calculated, and standardized per a 52-week period according to the formula described below. Annual Event Rate = No. of Events\*365.25 / (Follow-up date - Date of randomization + 1).
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Annual Event Rate of Moderate and Severe COPD Exacerbations and Early Drop-outs (Including Drop-outs Due to Any Cause)
|
2.17 Events / year
Standard Error 0.80
|
1.55 Events / year
Standard Error 0.60
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Time to First Moderate or Severe Exacerbation
|
NA days
Interval 5.0 to
Too few events were observed in the treatment group for the estimation of median using Kaplan-Meier methodology.
Too few events were observed for the estimation of the upper limit of the full range.
|
NA days
Interval 4.0 to
Too few events were observed in the placebo group for the estimation of median using Kaplan-Meier methodology.
Too few events were observed for the estimation of the upper limit of the full range.
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below. Annual Exacerbation Rate = No. of Exacerbations\*365.25 / (Follow-up date - Date of randomization + 1).
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Annual Exacerbation Rate of Moderate and Severe Exacerbations
|
2.12 Exacerbations / year
Standard Error 0.78
|
1.42 Exacerbations / year
Standard Error 0.56
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Time to First Moderate or Severe Exacerbation (Where Worsening of COPD Symptoms is Defined as Anthonisens Criteria Fulfilled)
|
NA days
Interval 6.0 to
Too few events were observed in the treatment group for the estimation of median using Kaplan-Meier methodology.
Too few events were observed for the estimation of the upper limit of the full range.
|
NA days
Interval 4.0 to
Too few events were observed in the placebo group for the estimation of median using Kaplan-Meier methodology.
Too few events were observed for the estimation of the upper limit of the full range.
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below. Annual Exacerbation Rate = No. of Exacerbations\*365.25 / (Follow-up date - Date of randomization + 1).
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Annual Exacerbation Rate of Moderate and Severe Exacerbations (Where Worsening of COPD Symptoms is Defined as Anthonisens Criteria Fulfilled)
|
1.23 Exacerbations / year
Standard Error 0.39
|
1.09 Exacerbations / year
Standard Error 0.37
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Time to First Symptom Defined Exacerbation (as Defined by the Exacerbation of Chronic Pulmonary Disease Tool [EXACT] Daily Diary)
|
NA days
Interval 3.0 to
Too few events were observed in the treatment group for the estimation of median using Kaplan-Meier methodology.
Too few events were observed for the estimation of the upper limit of the full range.
|
NA days
Interval 2.0 to
Too few events were observed in the placebo group for the estimation of median using Kaplan-Meier methodology.
Too few events were observed for the estimation of the upper limit of the full range.
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
For the production of summary statistics, the annual exacerbation rate per subject is calculated, and standardized per a 52-week period according to the formula described below. Annual Exacerbation Rate = No. of Exacerbations\*365.25 / (Follow-up date - Date of randomization + 1).
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Annual Exacerbation Rate of Symptom Defined Exacerbations (as Defined by the EXACT Daily Diary)
|
1.96 Exacerbations / year
Standard Error 0.54
|
2.33 Exacerbations / year
Standard Error 0.64
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. One further patient was not included in the analysis due to missing covariate data.
The EXACT for Respiratory Symptoms (E-RS) scale is a derivative instrument comprising a subset of 11 of the EXACT items to evaluate the severity of respiratory symptoms of COPD. Summation of E-RS item responses produces a total score ranging from 0 to 40, with higher scores indicating greater severity.
Outcome measures
| Measure |
AZD7624
n=106 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Symptoms of COPD (Using the EXACT for Respiratory Symptoms [E-RS] Total Score, a Subset of Items From the EXACT Diary)
|
-0.21 scores on a scale
Standard Error 0.88
|
0.17 scores on a scale
Standard Error 0.91
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.
The SGRQ-C is a modified version of the St. George's Respiratory Questionnaire, which has been developed to measure the impact of respiratory disease on health status. The SGRQ-C includes 14 questions in 3 domains: symptoms; activity; and impacts. Scores range from 0 to 100 with higher scores indicating benefit. Change in total score from pre study-treatment baseline to Week 12 end of treatment visit are reported.
Outcome measures
| Measure |
AZD7624
n=107 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Health Related Quality of Life (as Assessed by St Georges Respiratory Questionnaire for COPD Patients [SGRQ-C])
|
-4.03 scores on a scale
Standard Deviation 19.574
|
-5.11 scores on a scale
Standard Deviation 17.809
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: The Full Analysis Set excluded one patient due to lack of source data and GCP compliance issues. Only patients with post-baseline TDI scores were included in the analysis.
The Baseline/Transitional Dyspnea Index (BDI/TDI) provides a multidimensional measure of dyspnea in relation to activities of daily living. The BDI provides a measure of dyspnoea at a single state, the baseline, and the TDI evaluates changes in dyspnoea from the baseline state. The instrument consists of three components: functional impairment, magnitude of task, and magnitude of effort. For the BDI, each of these three components are rated in five grades from 0 (severe) to 4 (unimpaired), and are summed to form a baseline total score from 0 to 12. For the TDI, changes in dyspnea are rated for each component by seven grades from -3 (major deterioration) to +3 (major improvement), and are added to form a total TDI score from -9 to +9. Positive scores indicate an improvement, and a change from the BDI or a difference between treatments of 1 point has been estimated to constitute the minimum clinically important difference.
Outcome measures
| Measure |
AZD7624
n=102 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=100 Participants
Matching placebo comparator
|
|---|---|---|
|
Dyspnea (Transitional Dyspnea Index (TDI) Score)
|
0.41 score on a scale
Standard Error 0.15
|
0.54 score on a scale
Standard Error 0.16
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.
Outcome measures
| Measure |
AZD7624
n=107 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough Forced Expiratory Volume in 1 Second (FEV1)
|
-0.003 Litres
Standard Deviation 0.2555
|
-0.028 Litres
Standard Deviation 0.2317
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.
Outcome measures
| Measure |
AZD7624
n=107 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough Forced Vital Capacity (FVC)
|
-0.045 Litres
Standard Deviation 0.4017
|
-0.018 Litres
Standard Deviation 0.3890
|
SECONDARY outcome
Timeframe: Up to Week 12 treatment discontinuation visit (in some patients this visit was delayed beyond the planned Day 84, up to maximum of 118 days)Population: Full Analysis Set excluding one patient due to lack of source data and GCP compliance issues.
Outcome measures
| Measure |
AZD7624
n=107 Participants
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 Participants
Matching placebo comparator
|
|---|---|---|
|
Pulmonary Function Measured as Changes From Baseline (Post-bronchodilator at Visit 3) in Trough FEV1/FVC Ratio
|
0.0077 L/L
Standard Deviation 0.05269
|
-0.0072 L/L
Standard Deviation 0.05255
|
Adverse Events
AZD7624
Serious events: 11 serious events
Other events: 71 other events
Deaths: 0 deaths
Placebo
Serious events: 11 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AZD7624
n=108 participants at risk
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 participants at risk
Matching placebo comparator
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
6.5%
7/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
5.7%
6/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Cardiac disorders
Angina unstable
|
0.00%
0/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.95%
1/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Cardiac disorders
Cardiac arrest
|
0.93%
1/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.00%
0/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Cardiac disorders
Coronary artery occlusion
|
0.93%
1/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.00%
0/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Hepatobiliary disorders
Biliary colic
|
0.00%
0/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.95%
1/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Hepatobiliary disorders
Cholelithiasis
|
0.00%
0/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.95%
1/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.93%
1/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.00%
0/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
0.00%
0/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.95%
1/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Gastrointestinal disorders
Nausea
|
0.93%
1/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.00%
0/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Infections and infestations
Urosepsis
|
0.93%
1/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.00%
0/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Injury, poisoning and procedural complications
Subdural haematoma
|
0.00%
0/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.95%
1/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Nervous system disorders
Syncope
|
0.00%
0/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.95%
1/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
Other adverse events
| Measure |
AZD7624
n=108 participants at risk
Active treatment 2 x 0.5mg inhalation qd
|
Placebo
n=105 participants at risk
Matching placebo comparator
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease
|
28.7%
31/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
21.9%
23/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
8/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
1.9%
2/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
7.4%
8/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
3.8%
4/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Nervous system disorders
Dysgeusia
|
4.6%
5/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.95%
1/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Infections and infestations
Influenza
|
4.6%
5/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
2.9%
3/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
3.7%
4/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.95%
1/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Infections and infestations
Bronchitis
|
3.7%
4/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
1.9%
2/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Infections and infestations
Nasopharyngitis
|
3.7%
4/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
3.8%
4/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
General disorders
Fatigue
|
2.8%
3/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.00%
0/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Vascular disorders
Hypertension
|
2.8%
3/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
1.9%
2/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Respiratory, thoracic and mediastinal disorders
Productive cough
|
2.8%
3/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
0.00%
0/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
General disorders
Asthenia
|
1.9%
2/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
3.8%
4/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Infections and infestations
Sinusitis
|
0.93%
1/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
2.9%
3/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
General disorders
Oedema peripheral
|
0.00%
0/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
2.9%
3/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/108 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
2.9%
3/105 • Serious adverse events (SAEs) were collected from informed consent throughout the study until follow-up (Week 14). Adverse events (AEs) were collected from Visit 2 (start of OCS treatment) throughout the study until follow-up (Week 14).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place