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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.
ClinicalTrials.gov Identifier: NCT00628953
Recruitment Status : Completed
First Posted : March 5, 2008
Last Update Posted : March 13, 2009
Sponsor:
Information provided by:
AstraZeneca

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

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
Primary Completion Date : April 2004
Study Completion Date : April 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma
U.S. FDA Resources

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

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier (NCT number): NCT00628953


Sponsors and Collaborators
AstraZeneca
Investigators
Study Director: Paula Fernstrom Nexium Global Product Director, AstraZeneca

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, AstraZeneca
ClinicalTrials.gov Identifier: NCT00628953     History of Changes
Other Study ID Numbers: SD-NEE-0003
D9611C00003
First Posted: March 5, 2008    Key Record Dates
Last Update Posted: March 13, 2009
Last Verified: March 2009

Keywords provided by AstraZeneca:
Asthma
Acid Reflux
Nexium
Esomeprazole

Additional relevant MeSH terms:
Esomeprazole
Anti-Ulcer Agents
Gastrointestinal Agents
Proton Pump Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action