Adult Asthmatics and Acid Reflux

This study has been completed.
Information provided by:
AstraZeneca Identifier:
First received: February 26, 2008
Last updated: March 12, 2009
Last verified: March 2009

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 Intervention Phase
Drug: Esomeprazole
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double-Blind
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

Resource links provided by NLM:

Further study details as provided by AstraZeneca:

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

Estimated Enrollment: 1400
Study Start Date: October 2002
Study Completion Date: April 2004
Primary Completion Date: April 2004 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 Drug: Esomeprazole
40mg twice a day
Other Name: Nexium
Placebo Comparator: 2 Drug: Placebo
40mg twice a day


Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its identifier: NCT00628953

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

No publications provided

Responsible Party: Tore Lind, MD - Nexium Medical Science Director, AstraZeneca Identifier: NCT00628953     History of Changes
Other Study ID Numbers: SD-NEE-0003, D9611C00003
Study First Received: February 26, 2008
Last Updated: March 12, 2009
Health Authority: United States: Food and Drug Administration
Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica
Bulgaria: Ministry of Health
Brazil: Ministry of Health
Canada: Health Canada
Czech Republic: State Institute for Drug Control
Finland: Finnish Medicines Agency
United Kingdom: Medicines and Healthcare Products Regulatory Agency
Hungary: National Institute of Pharmacy
Italy: Ministry of Health
Mexico: Ministry of Health
Romania: National Medicines Agency
South Africa: Department of Health

Keywords provided by AstraZeneca:
Acid Reflux

Additional relevant MeSH terms:
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Anti-Ulcer Agents
Gastrointestinal Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on April 16, 2014