Study of Acid Reflux in Asthma

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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.

Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
Placebo	40 mg of placebo twice daily
Esomeprazole	40 mg of esomeprazole twice daily

Participant Flow:   Overall Study

	Placebo	Esomeprazole
STARTED	199 [1]	203 [1]
COMPLETED	193	200
NOT COMPLETED	6	3
Did not have follow-up diary cards	6	3

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups

	Description
Placebo	40 mg of placebo twice daily
Esomeprazole	40 mg of esomeprazole twice daily
Total	Total of all reporting groups

Baseline Measures

	Placebo	Esomeprazole	Total
Overall Participants Analyzed  [Units: Participants]	199	203	402
Age  [Units: Years] Mean (Standard Deviation)	42  (13)	42  (13)	42  (13)
Gender  [Units: Participants]
Female	143	130	273
Male	56	73	129
Race/Ethnicity, Customized [1]  [Units: Participants]
White	103	102	205
Black	73	79	152
Hispanic	17	18	35
Other	6	4	10
[1] Race or ethnic group was self-reported.
Asthma medication use  [Units: Participants]
Inhaled corticosteroids	50	44	94
Combination of fluticasone and salmeterol	149	159	308
Body-mass index >=30 [1]  [Units: Participants]
BMI >=30	107	102	209
BMI <30	92	101	193
[1] The body-mass index is the weight in kilograms divided by the square of the height in meters.
Conditions other than asthma [1]  [Units: Participants]
Gastroesophageal reflux disease	38	21	59
No GER reported	161	182	343
[1] These conditions were self-reported.
Former smoker  [Units: Participants]
Former Smoker	40	31	71
Never smoked	159	172	331
Health Care Visits [1]  [Units: Participants]
Health care visit for asthma exacerbation	126	109	235
No visit	73	94	167
[1] Unscheduled health care visit for asthma in previous year
Pulmonary function  [Units: Participants]
Participants with 20% post-diluent measurement	92	83	175
20% from post-diluent contraindicated	102	117	219
Missing	5	3	8
potential Hydrogen (pH) monitoring [1]  [Units: Participants]
Positive result	62	61	123
Negative result	89	92	181
Missing result	48	50	98
[1] Results of ambulatory measure of esophageal potential Hydrogen (pH) for 16 to 24 hours. Test were considered positive if pH was less than 4 for more than 5.8% of the total tiem, 8.2% of upright time, or 3.5% of supine time.
%Predicted amount of air expired in the first second during a forced expiration pre broncho-dilator [1]  [Units: Percent] Mean (Standard Deviation)	78  (15)	76  (16)	77  (16)
[1] Percent of the predicted value for the amount of air expired in the first second during a forced expiratory maneuver (FEV1) based on gender, age and ethnicity that the measured value is.
Age of onset of asthma  [Units: Years] Mean (Standard Deviation)	17  (17)	17  (16)	17  (16)
Age of participants  [Units: Years] Mean (Standard Deviation)
at randomization	42  (13)	42  (13)	42  (13)
at onset of asthma	17  (17)	17  (16)	17  (16)
Asthma scores [1]  [Units: Score] Mean (Standard Deviation)
ACQ	1.9  (0.8)	1.8  (0.8)	1.8  (0.8)
ASUI	0.74  (0.18)	0.76  (0.15)	0.75  (0.15)
mini asthma quality of life questionnaire	4.7  (1.2)	4.7  (1.2)	4.7  (1.2)
[1] Asthma Control Score (ACS)ranges from 0 to 6, lower scores indicating better asthma control and 0.5 as the minimal clinically important difference; Asthma Symptom Utility Index (ASUI) score ranges from 0 to 1, higher scores indicating less severe asthma; Mini-Asthma Quality of Life Questionnaire (mini-AQLQ) score range from 1 to 7, higher scores indicating better quality of life and 0.5 as the minimal clinically important difference.
Percent change in FEV1 after bronchodilator [1]  [Units: Percent change] Mean (Standard Deviation)	10  (10)	11  (16)	11  (13)
[1] The percent difference in FEV1 before and after using a bronchodilator (albuterol) divided by the value before bronchodilation.

1.  Primary:

Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion   [ Time Frame: Baseline to 24 Weeks ]

2.  Secondary:

Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days   [ Time Frame: Baseline to 24 Weeks ]

3.  Secondary:

Exacerbation Components: Urgent Care Visit   [ Time Frame: Measured at Month 6 ]

4.  Secondary:

Exacerbation Components: New Use of Oral Corticosteroids   [ Time Frame: Baseline to 24 Weeks ]

5.  Secondary:

Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists   [ Time Frame: Baseline to 24 Weeks ]

6.  Secondary:

Use of Rescue Medications   [ Time Frame: Baseline to 24 Weeks ]

7.  Secondary:

Night Awakening   [ Time Frame: Baseline to 24 Weeks ]

8.  Secondary:

Pulmonary Function: Change in Prebronchodilator FEV1   [ Time Frame: Baseline to 24 Weeks ]

9.  Secondary:

Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity   [ Time Frame: Baseline to 24 Weeks ]

10.  Secondary:

Pulmonary Function: Change in Peak Flow Rate   [ Time Frame: Baseline to 24 Weeks ]

11.  Secondary:

Pulmonary Function: Change in PC20   [ Time Frame: Baseline to 24 Weeks ]

12.  Secondary:

Change in Juniper Asthma Control Score(JACQ)   [ Time Frame: Baseline to 24 Weeks ]

13.  Secondary:

Change in Asthma Symptom Utility Index (ASUI)   [ Time Frame: Baseline to 24 Weeks ]

14.  Secondary:

Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)   [ Time Frame: Baseline to 24 Weeks ]

15.  Secondary:

Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component   [ Time Frame: Baseline to 24 Weeks ]

16.  Secondary:

Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component   [ Time Frame: Baseline to 24 Weeks ]

17.  Secondary:

Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score   [ Time Frame: Baseline to 24 Weeks ]

18.  Secondary:

Change in Number of Gastric Symptoms: No. of Symptoms   [ Time Frame: Baseline to 24 Weeks ]

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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