Adult Asthmatics and Acid Reflux

This study has been completed.
Sponsor:
Information provided by:
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00628953
First received: February 26, 2008
Last updated: March 12, 2009
Last verified: March 2009
  Purpose

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
Asthma
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

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00628953

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

No publications provided

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
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:
Asthma
Acid Reflux
Nexium
Esomeprazole

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

ClinicalTrials.gov processed this record on October 21, 2014