COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC:

Get the latest research information from NIH: Menu

Adult Asthmatics and Acid Reflux

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00628953
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : March 13, 2009
Information provided by:

Brief Summary:
The purpose of this study is to assess the efficacy and safety of Nexium in the treatment of subjects with persistent asthma believed to have acid reflux as a contributory factor to control of their asthma.

Condition or disease Intervention/treatment Phase
Asthma Drug: Esomeprazole Drug: Placebo Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1400 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: A Randomized, Double-Blind, Parallel Group Multicenter Efficacy and Safety Phase IIB Pilot Study of Esomeprazole 40mg Bid Versus Placebo Bid in Adult Asthmatics Treated for 4 Months
Study Start Date : October 2002
Actual Primary Completion Date : April 2004
Actual Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: 1 Drug: Esomeprazole
40mg twice a day
Other Name: Nexium

Placebo Comparator: 2 Drug: Placebo
40mg twice a day

Primary Outcome Measures :
  1. Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores [ Time Frame: 4 weekly ]

Secondary Outcome Measures :
  1. Safety as assessed by adverse event recording and clinical and laboratory measurements. [ Time Frame: 4 weekly ]

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Layout table for eligibility information
Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Clinical diagnosis of asthma
  • Forced Expiratory Volume and Peak Expiratory Flow as defined by the protocol
  • Daily use of inhaled GCS and/or leukotriene pathway modifier for greater than 3 months.
  • Severe heartburn 3 days/week during the run-in period.

Exclusion Criteria:

  • Subjects with a history of 3 sinus infections treated with antibiotics in the year prior to Visit 1.
  • Any other significant disease or pathology judged to be clinically significant by the investigator

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00628953

Sponsors and Collaborators
Layout table for investigator information
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca
Layout table for additonal information
Responsible Party: Tore Lind, MD - Nexium Medical Science Director, AstraZeneca Identifier: NCT00628953    
Other Study ID Numbers: SD-NEE-0003
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009
Keywords provided by AstraZeneca:
Acid Reflux
Additional relevant MeSH terms:
Layout table for MeSH terms
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action