Phase 3 N=402 Randomized Quadruple-blind Treatment

Study of Acid Reflux in Asthma

Asthma · Lung Diseases · Lung Diseases, Obstructive

Bottom Line

View on ClinicalTrials.gov: NCT00069823 ↗

Enrolled (actual)

402

Serious AEs

6.5%

Results posted

Oct 2012

Primary outcome: Primary: 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; 2.5 events per person year — p=0.66

Study Design & Population

Study type: Interventional
Phase: Phase 3
Interventions: Esomeprazole (Drug); Placebo proton pump inhibitor (Drug)
Age: Adult, Older Adult · 18+ yrs
Sex: All
Sponsor: Johns Hopkins Bloomberg School of Public Health
Primary completion: May 2008

Outcome Measures

Outcome	Result	p-value
PRIMARY 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; 2.5	0.66
SECONDARY Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days	1.7; 2.1	0.35
SECONDARY Exacerbation Components: Urgent Care Visit	0.6; 0.5	0.79
SECONDARY Exacerbation Components: New Use of Oral Corticosteroids	0.6; 0.5	0.62
SECONDARY Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists	4.4; 4.3	0.87
SECONDARY Use of Rescue Medications	3.0; 2.8	0.62
SECONDARY Night Awakening	30; 28	0.70
SECONDARY Pulmonary Function: Change in Prebronchodilator FEV1	-0.02; 0.00	0.36
SECONDARY Pulmonary Function: Change in Prebronchodilator Forced Vital Capacity	-0.03; 0.00	0.30
SECONDARY Pulmonary Function: Change in Peak Flow Rate	3.2; 9.2	0.24
SECONDARY Pulmonary Function: Change in PC20	1.5; 0.3	0.04 sig
SECONDARY Change in Juniper Asthma Control Score(JACQ)	-0.3; -0.2	0.11
SECONDARY Change in Asthma Symptom Utility Index (ASUI)	0.05; 0.02	0.11
SECONDARY Change in the Mini-Asthma Quality of Life Questionnaire (Mini-AQLQ)	0.3; 0.3	0.33
SECONDARY Change in Medical Outcomes Study Short-Form 36 Score Quality of Life Score: Physical Component	2.0; 1.1	0.16
SECONDARY Change in Medical Outcomes Study Short-Form 36 Quality of Life Score: Mental Component	0.0; 0.4	0.56
SECONDARY Change in Gastric Symptoms: Gastroesophageal Reflux Disease Symptom Assessment Scale Score	-0.17; -0.16	0.76
SECONDARY Change in Number of Gastric Symptoms: No. of Symptoms	-1.7; -1.9	0.39

Summary

The purpose of this study is to determine if subjects with symptomatic asthma who are assigned to treatment with a proton pump inhibitor (PPI) drug such as Nexium have fewer asthma attacks than similar subjects assigned to placebo treatment.

Eligibility Criteria

Inclusion Criteria

The general goal of patient selection is to enroll patients for whom asthma physicians might prescribe GERD treatment, but where there is uncertainty whether it might be effective.
Age 18 or older
Physician diagnosed asthma
If amount of air expired in the first second during a forced expiratory maneuver (FEV1) is greater than or equal to 70% predicted normal pre-bronchodilator: demonstrate methacholine 20% from post-diluent baseline (PC20). PC20 less than 16 mg/ml during Visit 1
If FEV1 less than 70% and greater than or equal to 50% predicted normal pre-bronchodilator: demonstrate 12% reversibility during Visit 1 or within past 12 months
Currently on stable dose of daily inhaled steroids for asthma control, i.e., inhaled corticosteroid equivalent to 400 ug/day of fluticasone44 or greater for 8 weeks or longer
Poor asthma control: Either of the following; a score of 1.5 or greater on the Juniper Asthma Control Questionnaire; two or more episodes of asthma symptoms in the past 12 months with each episode requiring at least one of the following: an emergency department visit, unscheduled physician visit, prednisone course, hospitalization
Non-smoker for 6 months or longer
Less than 10 pack/year smoking history

Exclusion Criteria

Surgery: Previous anti-reflux or peptic ulcer surgery
Pulmonary function: FEV1 less than 50% predicted normal pre-bronchodilator
GERD Symptoms: Severe reflux constituting a clinical indication for treatment with a PPI or H2 blocker, typically two or more episodes per week of heartburn requiring antacids
Other major chronic illnesses; conditions which in the judgment of the Study Physician would interfere with participation in the study, e.g., non-skin cancer, endocrine disease, coronary artery disease, congestive heart failure, stroke, severe hypertension, Type 1 insulin dependent diabetes mellitus, renal failure, liver disorders, immunodeficiency states, major neuropsychiatric disorder
Medication use: Anti-reflux medication (proton pump inhibitors or H2 blockers) within 1 month Theophylline, azoles, iron, anti-coagulants, insulin (for Type I diabetes), digitalis, any investigative drugs within 1 month
Drug allergy: Previous adverse effects from proton pump inhibitors or methacholine challenge
Females of childbearing potential: Pregnant or lactating, unwilling to practice an adequate birth control method (abstinence, combination barrier and spermicide, or hormonal)
Inability or unwillingness to provide consent
Inability to perform baseline measurements
Completion of less than 10 of the last 14 days of screening period diary entry
Inability to be contacted by telephone
Intention to move out of the area within 6 months

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00069823). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.