Study of Acid Reflux in Asthma

NCT00069823 | Completed Phase 3 Results DMC

• 2 other identifiers: 157U01HL072968
• Study Type: interventional
• Target: 403
• Locations: 1 country
• Sites: 20

Brief 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.

Conditions

Asthma; Lung Diseases; Lung Diseases, Obstructive

Outcome Measures

Primary Outcomes (1)

• Episodes of Poor Asthma Control (EPAC) From Diary Cards, According to Definition That Did Not Include Use of Beta-agonists as a Criterion

  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

  Baseline to 24 Weeks

Secondary Outcomes (17)

• Exacerbation Components: >=30% Drop in Peak Expiratory Flow on 2 Consecutive Days

  Baseline to 24 Weeks

• Exacerbation Components: Urgent Care Visit

  Measured at Month 6

• Exacerbation Components: New Use of Oral Corticosteroids

  Baseline to 24 Weeks

• Asthma Episodes, According to Definition That Included Increased Use of Beta-agonists

  Baseline to 24 Weeks

• Use of Rescue Medications

  Baseline to 24 Weeks

Study Arms (2)

Esomeprazole

EXPERIMENTAL

Proton pump inhibitor of gastric acid

Drug: Esomeprazole

Placebo for esomeprazoe

PLACEBO COMPARATOR

Placebo

Drug: Placebo proton pump inhibitor

Interventions

Esomeprazole DRUG

Proton pump inhibitor 40 mg orally twice daily

Also known as: Nexium

Esomeprazole

Placebo proton pump inhibitor DRUG

Placebo proton pump inhibitor

Placebo for esomeprazoe

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins Bloomberg School of Public Health: lead
• American Lung Association Asthma Clinical Research Centers: collaborator
• National Heart, Lung, and Blood Institute (NHLBI): collaborator

Study Sites (20)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

University of California, San Diego

San Diego, California, 92103, United States

Location

National Jewish Medical and Research Center

Denver, Colorado, 80206, United States

Location

Nemours Childrens Clinic

Jacksonville, Florida, 32207, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

Northwestern Memorial Hospital

Chicago, Illinois, 60611, United States

Location

Indiana University ACRC

Indianapolis, Indiana, 46202, United States

Location

LSUHSC Pulmonary Critical Care

New Orleans, Louisiana, 70112, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55455, United States

Location

Univ of MO Kansas City School of Medicine

Kansas City, Missouri, 64108, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63310-1093, United States

Location

North Shore-LIJ Medical Center

New Hyde Park, New York, 11040, United States

Location

NYU School of Medicine

New York, New York, 10016, United States

Location

New York Medical College

Valhalla, New York, 10595, United States

Location

Duke University

Durham, North Carolina, 27710, United States

Location

Ohio State University

Columbus, Ohio, 43210, United States

Location

Thomas Jefferson Hospital Pulmonary Lab

Philadelphia, Pennsylvania, 19107, United States

Location

Baylor College of Medicine

Houston, Texas, 77030-3411, United States

Location

Northern New England Consortium

Colchester, Vermont, 05446, United States

Location

Related Publications (5)

• Kaminsky DA, He J, Henderson R, Dixon AE, Irvin CG, Mastronarde J, Smith LJ, Sugar EA, Wise RA, Holbrook JT. Bronchodilator response does not associate with asthma control or symptom burden among patients with poorly controlled asthma. Respir Med. 2023 Nov;218:107375. doi: 10.1016/j.rmed.2023.107375. Epub 2023 Aug 1.

  PMID: 37536444 DERIVED

• Bime C, Wei CY, Holbrook JT, Sockrider MM, Revicki DA, Wise RA. Asthma symptom utility index: reliability, validity, responsiveness, and the minimal important difference in adult asthmatic patients. J Allergy Clin Immunol. 2012 Nov;130(5):1078-84. doi: 10.1016/j.jaci.2012.07.058. Epub 2012 Sep 29.

  PMID: 23026499 DERIVED

• Bime C, Wei CY, Holbrook J, Smith LJ, Wise RA. Association of dietary soy genistein intake with lung function and asthma control: a post-hoc analysis of patients enrolled in a prospective multicentre clinical trial. Prim Care Respir J. 2012 Dec;21(4):398-404. doi: 10.4104/pcrj.2012.00073.

  PMID: 22885561 DERIVED

• DiMango E, Holbrook JT, Simpson E, Reibman J, Richter J, Narula S, Prusakowski N, Mastronarde JG, Wise RA; American Lung Association Asthma Clinical Research Centers. Effects of asymptomatic proximal and distal gastroesophageal reflux on asthma severity. Am J Respir Crit Care Med. 2009 Nov 1;180(9):809-16. doi: 10.1164/rccm.200904-0625OC. Epub 2009 Aug 6.

  PMID: 19661245 DERIVED

• American Lung Association Asthma Clinical Research Centers; Mastronarde JG, Anthonisen NR, Castro M, Holbrook JT, Leone FT, Teague WG, Wise RA. Efficacy of esomeprazole for treatment of poorly controlled asthma. N Engl J Med. 2009 Apr 9;360(15):1487-99. doi: 10.1056/NEJMoa0806290.

  PMID: 19357404 DERIVED

MeSH Terms

Conditions

Asthma; Lung Diseases; Lung Diseases, Obstructive

Interventions

Esomeprazole

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Omeprazole; 2-Pyridinylmethylsulfinylbenzimidazoles; Sulfoxides; Sulfur Compounds; Organic Chemicals; Pyridines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring

Results Point of Contact

• Title: Ellen Brown
• Organization: Johns Hopkins University

ala-acrc@jhsph.edu

443-287-3170

Study Officials

• Robert Wise

  Johns Hopkins University School of Public Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: October 1, 2003
• First Posted: October 3, 2003
• Study Start: September 1, 2003
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 19, 2012
• Results First Posted: October 19, 2012

Record last verified: 2012-12

Locations

US (20)