Trial Outcomes & Findings for Long-acting Beta Agonist Step Down Study (NCT NCT01437995)
NCT ID: NCT01437995
Last Updated: 2017-04-25
Results Overview
Rate of treatment failures assessed by decline in peak flow or FEV1, increased need for beta agonists, requirement for non-scheduled medical care for asthma symptoms, or prednisone taper.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
459 participants
Primary outcome timeframe
48 weeks
Results posted on
2017-04-25
Participant Flow
Enrolled participants were enrolled in an 8-week open label treatment run-in and were subsequently randomized only if their asthma remained stable (i.e. an ACT score ≥ 20 at weeks 4 \& 8, no unscheduled healthcare encounters, no change in asthma medication, pre-bronchodilator FEV1 ≥ 70% predicted, and limited use of rescue beta-agonist).
Participant milestones
| Measure |
Stable ICS-LABA
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
|
Reduced ICS/LABA
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
|
LABA Step Off
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
|
|---|---|---|---|
|
Overall Study
STARTED
|
151
|
149
|
155
|
|
Overall Study
Included in Treatment Failure Analysis
|
150
|
146
|
151
|
|
Overall Study
COMPLETED
|
140
|
131
|
135
|
|
Overall Study
NOT COMPLETED
|
11
|
18
|
20
|
Reasons for withdrawal
| Measure |
Stable ICS-LABA
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
|
Reduced ICS/LABA
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
|
LABA Step Off
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
|
|---|---|---|---|
|
Overall Study
Lost to Follow-up
|
11
|
18
|
20
|
Baseline Characteristics
The Marks AQLQ is for adults only and was only administered to adult participants (individuals age 18 or older).
Baseline characteristics by cohort
| Measure |
Stable ICS-LABA
n=151 Participants
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
|
Reduced ICS/LABA
n=149 Participants
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
|
LABA Step Off
n=155 Participants
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
|
Total
n=455 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
36 years
n=151 Participants
|
33 years
n=149 Participants
|
35 years
n=155 Participants
|
35 years
n=455 Participants
|
|
Age, Customized
<18
|
31 participants
n=151 Participants
|
39 participants
n=149 Participants
|
30 participants
n=155 Participants
|
100 participants
n=455 Participants
|
|
Age, Customized
>=18
|
120 participants
n=151 Participants
|
110 participants
n=149 Participants
|
125 participants
n=155 Participants
|
355 participants
n=455 Participants
|
|
Sex: Female, Male
Female
|
96 Participants
n=151 Participants
|
88 Participants
n=149 Participants
|
103 Participants
n=155 Participants
|
287 Participants
n=455 Participants
|
|
Sex: Female, Male
Male
|
55 Participants
n=151 Participants
|
61 Participants
n=149 Participants
|
52 Participants
n=155 Participants
|
168 Participants
n=455 Participants
|
|
Race/Ethnicity, Customized
White
|
72 participants
n=151 Participants
|
74 participants
n=149 Participants
|
75 participants
n=155 Participants
|
221 participants
n=455 Participants
|
|
Race/Ethnicity, Customized
Black
|
52 participants
n=151 Participants
|
48 participants
n=149 Participants
|
51 participants
n=155 Participants
|
151 participants
n=455 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
19 participants
n=151 Participants
|
23 participants
n=149 Participants
|
24 participants
n=155 Participants
|
66 participants
n=455 Participants
|
|
Race/Ethnicity, Customized
Other
|
8 participants
n=151 Participants
|
4 participants
n=149 Participants
|
5 participants
n=155 Participants
|
17 participants
n=455 Participants
|
|
Region of Enrollment
United States
|
151 participants
n=151 Participants
|
149 participants
n=149 Participants
|
155 participants
n=155 Participants
|
455 participants
n=455 Participants
|
|
Smoke exposure
Former smoker
|
23 participants
n=151 Participants
|
25 participants
n=149 Participants
|
14 participants
n=155 Participants
|
62 participants
n=455 Participants
|
|
Smoke exposure
Secondhand smoke home/work
|
18 participants
n=151 Participants
|
21 participants
n=149 Participants
|
17 participants
n=155 Participants
|
56 participants
n=455 Participants
|
|
Asthma characteristics
Hospitalized for asthma in past year
|
5 participants
n=151 Participants
|
3 participants
n=149 Participants
|
6 participants
n=155 Participants
|
14 participants
n=455 Participants
|
|
Asthma characteristics
Oral steroids in past year
|
44 participants
n=151 Participants
|
36 participants
n=149 Participants
|
42 participants
n=155 Participants
|
122 participants
n=455 Participants
|
|
Asthma characteristics
Daily short-acting beta agonist use
|
7 participants
n=151 Participants
|
12 participants
n=149 Participants
|
10 participants
n=155 Participants
|
29 participants
n=455 Participants
|
|
Asthma characteristics
Daily anti-leukotriene use
|
32 participants
n=151 Participants
|
30 participants
n=149 Participants
|
30 participants
n=155 Participants
|
92 participants
n=455 Participants
|
|
Age of Asthma Onset
|
7 years
n=151 Participants
|
7 years
n=149 Participants
|
7 years
n=155 Participants
|
7 years
n=455 Participants
|
|
eNO (exhaled nitric oxide)
|
18.5 parts per billion
n=151 Participants
|
17.5 parts per billion
n=149 Participants
|
16.5 parts per billion
n=155 Participants
|
17.5 parts per billion
n=455 Participants
|
|
Atopy (phadiatop ≥ 0.35 kUA/l)
|
115 participants
n=151 Participants
|
123 participants
n=149 Participants
|
114 participants
n=155 Participants
|
352 participants
n=455 Participants
|
|
Asthma Symptom Utility Index
|
0.95 units on a scale
n=151 Participants
|
0.94 units on a scale
n=149 Participants
|
0.98 units on a scale
n=155 Participants
|
0.95 units on a scale
n=455 Participants
|
|
Pulmonary function measures
Pre-bronchodilator FEV1
|
2.82 Liters
n=151 Participants
|
2.86 Liters
n=149 Participants
|
2.82 Liters
n=155 Participants
|
2.83 Liters
n=455 Participants
|
|
Pulmonary function measures
Pre-bronchodilator FVC
|
3.54 Liters
n=151 Participants
|
3.62 Liters
n=149 Participants
|
3.65 Liters
n=155 Participants
|
3.62 Liters
n=455 Participants
|
|
Pulmonary function measures
Post-bronchodilator FEV1
|
2.88 Liters
n=151 Participants
|
2.96 Liters
n=149 Participants
|
2.93 Liters
n=155 Participants
|
2.92 Liters
n=455 Participants
|
|
Pulmonary function measures
Post-bronchodilator FVC
|
3.59 Liters
n=151 Participants
|
3.72 Liters
n=149 Participants
|
3.65 Liters
n=155 Participants
|
3.62 Liters
n=455 Participants
|
|
Pulmonary function measures, percent predicted
Pre-bronchodilator FEV1
|
91 percent predicted
n=151 Participants
|
91 percent predicted
n=149 Participants
|
92 percent predicted
n=155 Participants
|
91 percent predicted
n=455 Participants
|
|
Pulmonary function measures, percent predicted
Pre-bronchodilator FVC
|
98 percent predicted
n=151 Participants
|
100 percent predicted
n=149 Participants
|
98 percent predicted
n=155 Participants
|
99 percent predicted
n=455 Participants
|
|
Pulmonary function measures, percent predicted
Pre-bronchodilator peak flow
|
96 percent predicted
n=151 Participants
|
100 percent predicted
n=149 Participants
|
98 percent predicted
n=155 Participants
|
98 percent predicted
n=455 Participants
|
|
Other conditions, based upon self-report
Eczema
|
35 participants
n=151 Participants
|
28 participants
n=149 Participants
|
26 participants
n=155 Participants
|
89 participants
n=455 Participants
|
|
Other conditions, based upon self-report
Sinusitis
|
50 participants
n=151 Participants
|
41 participants
n=149 Participants
|
34 participants
n=155 Participants
|
125 participants
n=455 Participants
|
|
Other conditions, based upon self-report
Allergic rhinitis
|
85 participants
n=151 Participants
|
73 participants
n=149 Participants
|
88 participants
n=155 Participants
|
246 participants
n=455 Participants
|
|
Other conditions, based upon self-report
Food allergies
|
33 participants
n=151 Participants
|
40 participants
n=149 Participants
|
34 participants
n=155 Participants
|
107 participants
n=455 Participants
|
|
Other conditions, based upon self-report
Allergies worsen asthma
|
123 participants
n=151 Participants
|
113 participants
n=149 Participants
|
122 participants
n=155 Participants
|
358 participants
n=455 Participants
|
|
Pre-bronchodilator peak flow
|
420 Liters per minute
n=151 Participants
|
430 Liters per minute
n=149 Participants
|
430 Liters per minute
n=155 Participants
|
430 Liters per minute
n=455 Participants
|
|
Asthma Control Test Score
|
23 units on a scale
n=151 Participants
|
23 units on a scale
n=149 Participants
|
23 units on a scale
n=155 Participants
|
23 units on a scale
n=455 Participants
|
|
Marks AQLQ
|
4.0 units on a scale
n=120 Participants • The Marks AQLQ is for adults only and was only administered to adult participants (individuals age 18 or older).
|
5.0 units on a scale
n=110 Participants • The Marks AQLQ is for adults only and was only administered to adult participants (individuals age 18 or older).
|
4.0 units on a scale
n=125 Participants • The Marks AQLQ is for adults only and was only administered to adult participants (individuals age 18 or older).
|
4.0 units on a scale
n=355 Participants • The Marks AQLQ is for adults only and was only administered to adult participants (individuals age 18 or older).
|
|
Children's Health Survey for Asthma - Child Version
Physical
|
93 units on a scale
n=31 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
93 units on a scale
n=39 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
96 units on a scale
n=30 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
93 units on a scale
n=100 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
|
Children's Health Survey for Asthma - Child Version
Activity
|
100 units on a scale
n=31 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
100 units on a scale
n=39 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
100 units on a scale
n=30 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
100 units on a scale
n=100 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
|
Children's Health Survey for Asthma - Child Version
Emotional
|
93 units on a scale
n=31 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
95 units on a scale
n=39 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
93 units on a scale
n=30 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
93 units on a scale
n=100 Participants • The Children's Health Survey for Asthma - Child Version (CHSA-C) is for use in individuals under the age of 18 only. The CHSA-C was administered only to those participants under the age of 18 in our study.
|
|
Euroqual EQ-5D-5L
|
1.00 units on a scale
n=151 Participants
|
1.00 units on a scale
n=149 Participants
|
1.00 units on a scale
n=155 Participants
|
1.00 units on a scale
n=455 Participants
|
PRIMARY outcome
Timeframe: 48 weeksRate of treatment failures assessed by decline in peak flow or FEV1, increased need for beta agonists, requirement for non-scheduled medical care for asthma symptoms, or prednisone taper.
Outcome measures
| Measure |
Stable ICS-LABA
n=150 Participants
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
|
Reduced ICS/LABA
n=146 Participants
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
|
LABA Step Off
n=151 Participants
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
|
|---|---|---|---|
|
Treatment Failure
|
38 participants
|
39 participants
|
45 participants
|
SECONDARY outcome
Timeframe: Baseline and 48 weeksChange in morning peak expiratory flow rate from the patients' daily diary cards, calculated at 48 weeks minus baseline (randomization)
Outcome measures
| Measure |
Stable ICS-LABA
n=150 Participants
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
|
Reduced ICS/LABA
n=146 Participants
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
|
LABA Step Off
n=151 Participants
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
|
|---|---|---|---|
|
Pulmonary Function- Change in Peak Expiratory Flow
|
-0.08 Liters per minute
Interval -8.1 to 7.94
|
4.40 Liters per minute
Interval -3.46 to 12.26
|
-14.16 Liters per minute
Interval -23.1 to -5.22
|
SECONDARY outcome
Timeframe: 48 weeksRate of episodes of poor asthma control (EPAC) defined by unscheduled medical care, hospitalization, use of oral corticosteroids and/or increased use of rescue medications and/or decrease of 30% or more in morning peak expiratory flow rate
Outcome measures
| Measure |
Stable ICS-LABA
n=152 Participants
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
|
Reduced ICS/LABA
n=147 Participants
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
|
LABA Step Off
n=153 Participants
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
|
|---|---|---|---|
|
Rate of Episodes of Poor Asthma Control
|
183 Episodes of poor asthma control
|
164 Episodes of poor asthma control
|
219 Episodes of poor asthma control
|
SECONDARY outcome
Timeframe: Baseline and 48 weeksChange in participant's pre-bronchodilator pulmonary function tests (FEV1 and FVC) calculated as 48 weeks minus baseline.
Outcome measures
| Measure |
Stable ICS-LABA
n=150 Participants
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
|
Reduced ICS/LABA
n=146 Participants
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
|
LABA Step Off
n=151 Participants
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
|
|---|---|---|---|
|
Change in Pulmonary Function: FEV1 and FVC
Pre-bronchodilator FVC
|
-0.01 Liters
Interval -0.06 to 0.04
|
-0.04 Liters
Interval -0.1 to 0.01
|
-0.09 Liters
Interval -0.14 to -0.03
|
|
Change in Pulmonary Function: FEV1 and FVC
Pre-bronchodilator FEV1
|
-0.02 Liters
Interval -0.07 to 0.03
|
-0.07 Liters
Interval -0.12 to -0.01
|
-0.13 Liters
Interval -0.18 to -0.09
|
SECONDARY outcome
Timeframe: Baseline and 48 weeksChange in participant's FEV1/FVC ratio calculated as 48 weeks minus baseline.
Outcome measures
| Measure |
Stable ICS-LABA
n=150 Participants
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
|
Reduced ICS/LABA
n=146 Participants
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
|
LABA Step Off
n=151 Participants
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
|
|---|---|---|---|
|
Pulmonary Function: Change in FEV1/FVC Ratio
|
-0.002 ratio
Interval -0.009 to 0.005
|
-0.009 ratio
Interval -0.016 to -0.002
|
-0.02 ratio
Interval -0.028 to -0.012
|
Adverse Events
Stable ICS-LABA
Serious events: 7 serious events
Other events: 110 other events
Deaths: 0 deaths
Reduced ICS/LABA
Serious events: 3 serious events
Other events: 102 other events
Deaths: 0 deaths
LABA Step Off
Serious events: 15 serious events
Other events: 100 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Stable ICS-LABA
n=151 participants at risk
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
|
Reduced ICS/LABA
n=149 participants at risk
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
|
LABA Step Off
n=155 participants at risk
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
|
|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.66%
1/151 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.65%
1/155 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma Exacerbation
|
0.00%
0/151 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
3.2%
5/155 • Number of events 5 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Vascular disorders
Hypertension
|
0.00%
0/151 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.65%
1/155 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Chest discomfort, shortness of breath
|
0.66%
1/151 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/155 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Vascular disorders
Stroke
|
0.66%
1/151 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/155 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Renal and urinary disorders
Acute renal failure, resolved
|
0.00%
0/151 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.65%
1/155 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Endocrine disorders
Elevated blood sugar
|
0.00%
0/151 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.67%
1/149 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.65%
1/155 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Endocrine disorders
Graves' Disease, diagnosis
|
0.00%
0/151 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.65%
1/155 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Gastrointestinal disorders
Partial small bowel obstruction
|
0.66%
1/151 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/155 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/151 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.65%
1/155 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Gastrointestinal disorders
Appendectomy
|
0.66%
1/151 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.65%
1/155 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Musculoskeletal and connective tissue disorders
Knee replacement (planned)
|
0.00%
0/151 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
1.3%
2/155 • Number of events 2 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Reproductive system and breast disorders
Pregnancy
|
0.66%
1/151 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
1.3%
2/149 • Number of events 2 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/155 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Injury, poisoning and procedural complications
Hospitalized for contusion
|
0.00%
0/151 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.65%
1/155 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Immune system disorders
Allergic reaction
|
0.66%
1/151 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.00%
0/149 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.65%
1/155 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
Other adverse events
| Measure |
Stable ICS-LABA
n=151 participants at risk
Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
Fluticasone/Salmeterol Diskus: Continuation of Fluticasone/Salmeterol Diskus 250/50 ug twice daily
|
Reduced ICS/LABA
n=149 participants at risk
Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
Fluticasone/Salmeterol Diskus: Reduced dose Fluticasone/Salmeterol Diskus 100/50 ug twice daily
|
LABA Step Off
n=155 participants at risk
Fluticasone Diskus alone 250 ug twice daily without Salmeterol
Fluticasone Diskus: Fluticasone Diskus alone 250 ug twice daily without Salmeterol
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
Skin bruising
|
7.9%
12/151 • Number of events 12 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
5.4%
8/149 • Number of events 8 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
5.8%
9/155 • Number of events 9 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory infection
|
29.8%
45/151 • Number of events 48 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
22.8%
34/149 • Number of events 35 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
29.7%
46/155 • Number of events 48 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
15.9%
24/151 • Number of events 28 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
23.5%
35/149 • Number of events 37 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
21.9%
34/155 • Number of events 35 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Hoarseness
|
17.2%
26/151 • Number of events 30 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
22.8%
34/149 • Number of events 34 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
13.5%
21/155 • Number of events 21 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Chest pain
|
7.9%
12/151 • Number of events 12 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
10.7%
16/149 • Number of events 16 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
11.6%
18/155 • Number of events 18 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
35.1%
53/151 • Number of events 55 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
37.6%
56/149 • Number of events 59 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
37.4%
58/155 • Number of events 61 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
22.5%
34/151 • Number of events 36 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
15.4%
23/149 • Number of events 25 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
16.8%
26/155 • Number of events 27 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
General disorders
Headache
|
25.2%
38/151 • Number of events 39 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
16.1%
24/149 • Number of events 29 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
23.9%
37/155 • Number of events 40 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Cardiac disorders
Increased/irregular heartbeat
|
4.0%
6/151 • Number of events 6 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
0.67%
1/149 • Number of events 1 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
3.9%
6/155 • Number of events 6 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
General disorders
Restlessness or nervousness
|
11.3%
17/151 • Number of events 18 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
9.4%
14/149 • Number of events 15 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
8.4%
13/155 • Number of events 13 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose/congestion
|
34.4%
52/151 • Number of events 60 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
32.2%
48/149 • Number of events 58 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
33.5%
52/155 • Number of events 55 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
|
Gastrointestinal disorders
Nausea/vomiting
|
10.6%
16/151 • Number of events 17 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
12.1%
18/149 • Number of events 18 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
7.7%
12/155 • Number of events 12 • 52 weeks
Adverse events were assessed via a questionnaire in the clinic visit form, which was completed at every visit. Adverse events were recorded for participants who had newly detected moderate or severe symptoms after baseline.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place