Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma (RELAX)

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00317044
First received: April 20, 2006
Last updated: March 11, 2009
Last verified: March 2009

April 20, 2006
March 11, 2009
April 2006
April 2008   (final data collection date for primary outcome measure)
Primary objective is to compare the anti-asthmatic effect of esomeprazole with that of placebo in adult asthmatics with gastroesophageal reflux by evaluating change in morning Peak Expiratory Flow from baseline (run-in) to treatment period.
Same as current
Complete list of historical versions of study NCT00317044 on ClinicalTrials.gov Archive Site
Secondary objectives are to investigate the effect on symptoms of GERD as measured by Reflux Disease Questionnaire from randomization to end of study and to assess safety and tolerability by AEs, laboratory tests, physical examination, and vital signs.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy Study to Determine Anti-Asthmatic Effect of Esomeprazole Magnesium; Nexium Reflux Asthma
A 6-Month Randomized, Double-Blind, Parallel-Group, Multicentre, Placebo-Controlled Phase II Study to Compare Anti-Asthmatic Effect and Safety of Esomeprazole (Nexium®) 40 mg Twice Daily or 40 mg Once Daily With Placebo in Adults With Asthma

The purpose of this study is to determine whether treatment with esomeprazole for 6 months will improve asthma in adult patients with moderate to severe asthma and symptoms of gastroesophageal reflux disease.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
  • Asthma
  • GERD
Drug: Esomeprazole
Not Provided
Kiljander TO, Junghard O, Beckman O, Lind T. Effect of esomeprazole 40 mg once or twice daily on asthma: a randomized, placebo-controlled study. Am J Respir Crit Care Med. 2010 May 15;181(10):1042-8. doi: 10.1164/rccm.200910-1537OC. Epub 2010 Jan 28.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
1100
April 2008
April 2008   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Adults with diagnosis of asthma since at least 6 months.
  • Symptoms of asthma during run-in.
  • At least 3 months history and present symptoms of 1 or more of the following: burning feeling behind breastbone, pain behind breastbone, acid taste in the mouth.

Exclusion Criteria:

  • Patients with clinically relevant abnormalities.
  • Patients with a smoking history of ≥10 pack-year.
  • Patients who have had previous surgery on the esophagus or the stomach.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
United States,   Argentina,   Bulgaria,   Canada,   Czech Republic,   France,   Germany,   Hungary,   Italy,   Mexico,   Poland,   Portugal,   Slovakia,   Switzerland
 
NCT00317044
D9618C00001, RELAX
Not Provided
Not Provided
AstraZeneca
Not Provided
Study Director: AstraZeneca Nexium Medical Science Director, MD AstraZeneca
AstraZeneca
March 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP