Trial Outcomes & Findings for Study of Acid Reflux in Asthma (NCT NCT00069823)
NCT ID: NCT00069823
Last Updated: 2012-12-19
Results Overview
Episodes of poor asthma control was defined as any one of the following: 2 consecutive days with a drop in peak flow \>=30% of baseline; urgent care for asthma; or new use of oral corticosteroids for asthma
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
403 participants
Primary outcome timeframe
Baseline to 24 Weeks
Results posted on
2012-12-19
Participant Flow
The planned enrollment was for 400 participants, 403 participants actually were enrolled and randomized in the trial. It is not uncommon for clinical trials not to exactly meet the sample size stated in the protocol.
Participant milestones
| Measure |
Placebo
40 mg of placebo twice daily
|
Esomeprazole
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Overall Study
STARTED
|
199
|
203
|
|
Overall Study
COMPLETED
|
193
|
200
|
|
Overall Study
NOT COMPLETED
|
6
|
3
|
Reasons for withdrawal
| Measure |
Placebo
40 mg of placebo twice daily
|
Esomeprazole
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Overall Study
Did not have follow-up diary cards
|
6
|
3
|
Baseline Characteristics
Study of Acid Reflux in Asthma
Baseline characteristics by cohort
| Measure |
Placebo
n=199 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=203 Participants
40 mg of esomeprazole twice daily
|
Total
n=402 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age Continuous
|
42 years
STANDARD_DEVIATION 13 • n=5 Participants
|
42 years
STANDARD_DEVIATION 13 • n=7 Participants
|
42 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Sex: Female, Male
Female
|
143 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
273 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
56 Participants
n=5 Participants
|
73 Participants
n=7 Participants
|
129 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
103 participants
n=5 Participants
|
102 participants
n=7 Participants
|
205 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black
|
73 participants
n=5 Participants
|
79 participants
n=7 Participants
|
152 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
17 participants
n=5 Participants
|
18 participants
n=7 Participants
|
35 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 participants
n=5 Participants
|
4 participants
n=7 Participants
|
10 participants
n=5 Participants
|
|
Asthma medication use
Inhaled corticosteroids
|
50 participants
n=5 Participants
|
44 participants
n=7 Participants
|
94 participants
n=5 Participants
|
|
Asthma medication use
Combination of fluticasone and salmeterol
|
149 participants
n=5 Participants
|
159 participants
n=7 Participants
|
308 participants
n=5 Participants
|
|
Body-mass index >=30
BMI >=30
|
107 participants
n=5 Participants
|
102 participants
n=7 Participants
|
209 participants
n=5 Participants
|
|
Body-mass index >=30
BMI <30
|
92 participants
n=5 Participants
|
101 participants
n=7 Participants
|
193 participants
n=5 Participants
|
|
Conditions other than asthma
Gastroesophageal reflux disease
|
38 participants
n=5 Participants
|
21 participants
n=7 Participants
|
59 participants
n=5 Participants
|
|
Conditions other than asthma
No GER reported
|
161 participants
n=5 Participants
|
182 participants
n=7 Participants
|
343 participants
n=5 Participants
|
|
Former smoker
Former Smoker
|
40 participants
n=5 Participants
|
31 participants
n=7 Participants
|
71 participants
n=5 Participants
|
|
Former smoker
Never smoked
|
159 participants
n=5 Participants
|
172 participants
n=7 Participants
|
331 participants
n=5 Participants
|
|
Health Care Visits
Health care visit for asthma exacerbation
|
126 participants
n=5 Participants
|
109 participants
n=7 Participants
|
235 participants
n=5 Participants
|
|
Health Care Visits
No visit
|
73 participants
n=5 Participants
|
94 participants
n=7 Participants
|
167 participants
n=5 Participants
|
|
Pulmonary function
Participants with 20% post-diluent measurement
|
92 participants
n=5 Participants
|
83 participants
n=7 Participants
|
175 participants
n=5 Participants
|
|
Pulmonary function
20% from post-diluent contraindicated
|
102 participants
n=5 Participants
|
117 participants
n=7 Participants
|
219 participants
n=5 Participants
|
|
Pulmonary function
Missing
|
5 participants
n=5 Participants
|
3 participants
n=7 Participants
|
8 participants
n=5 Participants
|
|
potential Hydrogen (pH) monitoring
Positive result
|
62 participants
n=5 Participants
|
61 participants
n=7 Participants
|
123 participants
n=5 Participants
|
|
potential Hydrogen (pH) monitoring
Negative result
|
89 participants
n=5 Participants
|
92 participants
n=7 Participants
|
181 participants
n=5 Participants
|
|
potential Hydrogen (pH) monitoring
Missing result
|
48 participants
n=5 Participants
|
50 participants
n=7 Participants
|
98 participants
n=5 Participants
|
|
%Predicted amount of air expired in the first second during a forced expiration pre broncho-dilator
|
78 Percent
STANDARD_DEVIATION 15 • n=5 Participants
|
76 Percent
STANDARD_DEVIATION 16 • n=7 Participants
|
77 Percent
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Age of onset of asthma
|
17 years
STANDARD_DEVIATION 17 • n=5 Participants
|
17 years
STANDARD_DEVIATION 16 • n=7 Participants
|
17 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Age of participants
at randomization
|
42 years
STANDARD_DEVIATION 13 • n=5 Participants
|
42 years
STANDARD_DEVIATION 13 • n=7 Participants
|
42 years
STANDARD_DEVIATION 13 • n=5 Participants
|
|
Age of participants
at onset of asthma
|
17 years
STANDARD_DEVIATION 17 • n=5 Participants
|
17 years
STANDARD_DEVIATION 16 • n=7 Participants
|
17 years
STANDARD_DEVIATION 16 • n=5 Participants
|
|
Asthma scores
ACQ
|
1.9 score
STANDARD_DEVIATION 0.8 • n=5 Participants
|
1.8 score
STANDARD_DEVIATION 0.8 • n=7 Participants
|
1.8 score
STANDARD_DEVIATION 0.8 • n=5 Participants
|
|
Asthma scores
ASUI
|
0.74 score
STANDARD_DEVIATION 0.18 • n=5 Participants
|
0.76 score
STANDARD_DEVIATION 0.15 • n=7 Participants
|
0.75 score
STANDARD_DEVIATION 0.15 • n=5 Participants
|
|
Asthma scores
mini asthma quality of life questionnaire
|
4.7 score
STANDARD_DEVIATION 1.2 • n=5 Participants
|
4.7 score
STANDARD_DEVIATION 1.2 • n=7 Participants
|
4.7 score
STANDARD_DEVIATION 1.2 • n=5 Participants
|
|
Percent change in FEV1 after bronchodilator
|
10 Percent change
STANDARD_DEVIATION 10 • n=5 Participants
|
11 Percent change
STANDARD_DEVIATION 16 • n=7 Participants
|
11 Percent change
STANDARD_DEVIATION 13 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to 24 WeeksEpisodes of poor asthma control was defined as any one of the following: 2 consecutive days with a drop in peak flow \>=30% of baseline; urgent care for asthma; or new use of oral corticosteroids for asthma
Outcome measures
| Measure |
Placebo
n=193 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=200 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion
|
2.3 events per person year
|
2.5 events per person year
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksOutcome measures
| Measure |
Placebo
n=193 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=200 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days
|
1.7 events per person-year
|
2.1 events per person-year
|
SECONDARY outcome
Timeframe: Measured at Month 6Outcome measures
| Measure |
Placebo
n=193 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=200 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Exacerbation Components: Urgent Care Visit
|
0.6 events per person-year
|
0.5 events per person-year
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksOutcome measures
| Measure |
Placebo
n=193 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=200 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Exacerbation Components: New Use of Oral Corticosteroids
|
0.6 events per person year
|
0.5 events per person year
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksOutcome measures
| Measure |
Placebo
n=193 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=200 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists
|
4.4 events per person-year
|
4.3 events per person-year
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksIncrease in the use of rescue meds by 4 or more uses on a particular day above the average uses during the run-in period.
Outcome measures
| Measure |
Placebo
n=193 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=200 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Use of Rescue Medications
|
3.0 events per person-year
|
2.8 events per person-year
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksRate of awakening at night because of asthma symptoms
Outcome measures
| Measure |
Placebo
n=193 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=200 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Night Awakening
|
30 events per person-year
|
28 events per person-year
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPopulation: The analyses are based on data from 191 participants in the placebo group and 201 in the esomeprazole group, with the following exception: 41 participants in the placebo group and 37 in the esomeprazole group for measurement of 20% post-diluent baseline (PC20).
Mean change in pre-bronchodilator FEV1 - forced expiratory volume in 1 second; a measure of pulmonary function. The treatment effect is the difference in the mean change in between the groups.
Outcome measures
| Measure |
Placebo
n=191 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=201 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Pulmonary Function: Change in Prebronchodilator FEV1
|
-0.02 liters
Interval -0.06 to 0.01
|
0.00 liters
Interval -0.04 to 0.04
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksPulmonary function measured by mean change in Prebronchodilator forced vital capacity from baseline to 24 weeks
Outcome measures
| Measure |
Placebo
n=191 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=201 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity
|
-0.03 liters
Interval -0.06 to 0.01
|
0.00 liters
Interval -0.04 to 0.05
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksMean change from baseline to 24 weeks in the peak flow rate - how forceful patient can blow out air
Outcome measures
| Measure |
Placebo
n=191 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=201 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Pulmonary Function: Change in Peak Flow Rate
|
3.2 liters/min
Interval -3.5 to 9.9
|
9.2 liters/min
Interval 1.8 to 16.6
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksMean Change in the dose of methacholine that results in a 20% drop in FEV1
Outcome measures
| Measure |
Placebo
n=41 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=37 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Pulmonary Function: Change in PC20
|
1.5 mg/ml
Interval 0.2 to 2.9
|
0.3 mg/ml
Interval -1.4 to 0.9
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksMean change. Scores on the JACQ range from 0 to 6, with lower scores indicating better asthma control and 0.5 as the minimal clinically important difference.
Outcome measures
| Measure |
Placebo
n=191 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=201 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Change in Juniper Asthma Control Score(JACQ)
|
-0.3 score
Interval -0.4 to -0.2
|
-0.2 score
Interval -0.3 to -0.1
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksMean change. Scores on the ASUI range from 0 to 1, with higher scores indicating less severe asthma.
Outcome measures
| Measure |
Placebo
n=191 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=201 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Change in Asthma Symptom Utility Index (ASUI)
|
0.05 score
Interval 0.03 to 0.07
|
0.02 score
Interval 0.01 to 0.04
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksMean change. Scores on the Mini-Asthma Quality of Life Questionnaire (mini-AQLQ)range from 1 to 7, with higher scores indicating better quality of life and 0.5 as the minimal clinically important difference.
Outcome measures
| Measure |
Placebo
n=191 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=201 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)
|
0.3 score
Interval 0.2 to 0.4
|
0.3 score
Interval 0.2 to 0.4
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksMean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.
Outcome measures
| Measure |
Placebo
n=191 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=201 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component
|
2.0 score
Interval 1.1 to 2.9
|
1.1 score
Interval 0.3 to 1.9
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksMean change. Scores on the Medical Outcomes Study Short-Form 36 range from 1 to 100, with higher scores indicating better quality of life and 5 as the minimal clinically important difference.
Outcome measures
| Measure |
Placebo
n=191 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=201 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component
|
0.0 score
Interval -1.8 to 1.1
|
0.4 score
Interval -0.5 to 1.4
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksMean change. The Gastroesophageal Reflux Disease Symptom Assessment Scale score ranges from 0 to 3, with lower numbers indicating less distress.
Outcome measures
| Measure |
Placebo
n=191 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=201 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score
|
-0.17 score
Interval -0.21 to -0.12
|
-0.16 score
Interval -0.2 to -0.11
|
SECONDARY outcome
Timeframe: Baseline to 24 WeeksMean change
Outcome measures
| Measure |
Placebo
n=191 Participants
40 mg of placebo twice daily
|
Esomeprazole
n=201 Participants
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Change in Number of Gastric Symptoms: No. of Symptoms
|
-1.7 symptoms
Interval -2.1 to -1.3
|
-1.9 symptoms
Interval -2.3 to -1.6
|
Adverse Events
Placebo
Serious events: 16 serious events
Other events: 0 other events
Deaths: 0 deaths
Esomeprazole
Serious events: 10 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo
n=199 participants at risk
40 mg of placebo twice daily
|
Esomeprazole
n=203 participants at risk
40 mg of esomeprazole twice daily
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Asthma exacerbation requiring hospitalization
|
2.1%
4/193 • Number of events 4
|
1.5%
3/203 • Number of events 3
|
|
General disorders
Hospitalization or emergency department visit for surgery, trauma, or other acute illness
|
4.7%
9/193 • Number of events 10
|
2.5%
5/203 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/193
|
0.49%
1/203 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Death from complications after surgery for endobronchial tumor
|
0.00%
0/193
|
0.49%
1/203 • Number of events 1
|
|
Cardiac disorders
Hospitalization for possible cardiac ischemia
|
1.0%
2/193 • Number of events 2
|
0.00%
0/203
|
|
Pregnancy, puerperium and perinatal conditions
Pregnancy
|
0.70%
1/143 • Number of events 1
|
0.00%
0/130
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place