Study of Acid Reflux in Asthma - Full Text View

Sponsors and Collaborators:	National Heart, Lung, and Blood Institute (NHLBI) American Lung Association Asthma Clinical Research Centers
Information provided by:	National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:	NCT00069823

Purpose

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.

Condition	Intervention	Phase
Asthma Lung Diseases Lung Diseases, Obstructive	Drug: Esomeprazole Drug: Placebo proton pump inhibitor	Phase III

MedlinePlus related topics: Asthma GERD

Drug Information available for: Esomeprazole magnesium Esomeprazole Sodium Omeprazole Omeprazole magnesium

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Efficacy Study
Official Title:	The Study of Acid Reflux in Asthma

Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Primary Outcome Measures:

Proportion of participants who have exacerbations of asthma, as defined by asthma diaries and interviews [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Asthma symptom and control scores [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
Asthma specific and generic health related quality of life [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
GERD symptoms [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
Health care use [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
Pulmonary function [ Time Frame: Measured at Month 6 ] [ Designated as safety issue: No ]
Airway reactivity [ Time Frame: Measured at 24 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment:	400
Study Start Date:	September 2003
Study Completion Date:	May 2008
Primary Completion Date:	May 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
1: Experimental Proton pump inhibitor of gastric acid	Drug: Esomeprazole Proton pump inhibitor 40 mg orally twice daily
2: Placebo Comparator Placebo	Drug: Placebo proton pump inhibitor Placebo proton pump inhibitor

Detailed Description:

BACKGROUND:

Gastroesophageal reflux (GERD) is frequent in asthmatics with poor asthma control, often occurs without symptoms, and can induce bronchoconstriction. Poorly controlled asthmatics are often treated for GERD with drugs that suppress gastric acid, but this treatment is expensive and the benefit of such treatment is not established. Proton pump inhibitors are a relatively new class of medications that provide highly effective treatment for GERD and associated problems. This success has led many doctors to begin PPI treatment in their asthma patients in an attempt to achieve better asthma control.

DESIGN NARRATIVE:

The randomized, placebo-controlled trial will enroll 400 asthmatics, ages 18 or older, who have poor asthma control on inhaled steroids, defined on the basis of excessive bronchodilator use, nocturnal awakenings, or frequent exacerbations. Participants will be randomly assigned to treatment with either a proton pump inhibitor, esomeprazole (Nexium) 40 mg twice a day, or matching placebo. The presence, severity, and temporal relationship of GERD to asthma symptoms will be documented with 24 hour ambulatory esophageal pH probe monitoring, but participants will be enrolled irrespective of the severity of GERD. The primary outcome measure is the proportion of participants who have exacerbations of asthma within a 6-month period defined by asthma diaries and interviews. Secondary outcome measures include asthma symptom and control scores, asthma-specific and generic health-related quality of life, GERD symptoms, health care use, pulmonary function, and airways reactivity. Pre-specified subgroup analyses will be conducted to determine if there are clinical or demographic characteristics that predict benefit from treatment of GERD in asthma.

Eligibility

Ages Eligible for Study:	18 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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 FEV1 is greater than or equal to 70% predicted normal pre-bronchodilator: demonstrate methacholine 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00069823

Show 20 Study Locations

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

American Lung Association Asthma Clinical Research Centers

Investigators

Principal Investigator:

Robert Wise

Johns Hopkins University School of Public Health

More Information

Responsible Party:	Johns Hopkins University School of Medicine / Bloomberg School of Public Health ( Robert A. Wise, MD )
Study ID Numbers:	157, U01 HL72968
Study First Received:	October 1, 2003
Last Updated:	July 18, 2008
ClinicalTrials.gov Identifier:	NCT00069823
Health Authority:	United States: Federal Government

Study placed in the following topic categories:

Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Lung Diseases
Hypersensitivity, Immediate

Omeprazole
Asthma
Gastroesophageal Reflux
Respiratory Hypersensitivity

Additional relevant MeSH terms:

Molecular Mechanisms of Pharmacological Action
Immune System Diseases
Bronchial Diseases
Therapeutic Uses

Anti-Ulcer Agents
Gastrointestinal Agents
Enzyme Inhibitors
Pharmacologic Actions

ClinicalTrials.gov processed this record on January 16, 2009