Adult Asthmatics and Acid Reflux - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00628953

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double-Blind, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Asthma GERD

Drug Information available for: Omeprazole Omeprazole magnesium Esomeprazole Sodium Esomeprazole magnesium

U.S. FDA Resources

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
1: Experimental	Drug: Esomeprazole 40mg twice a day
2: Placebo Comparator	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

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:	AstraZeneca ( Tore Lind, MD - Nexium Medical Science Director )
Study ID Numbers:	SD-NEE-0003, D9611C00003
Study First Received:	February 26, 2008
Last Updated:	March 12, 2009
ClinicalTrials.gov Identifier:	NCT00628953 History of Changes
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:

Molecular Mechanisms of Pharmacological Action
Bronchial Diseases
Immune System Diseases
Gastrointestinal Agents
Asthma
Omeprazole
Enzyme Inhibitors
Pharmacologic Actions

Lung Diseases, Obstructive
Hypersensitivity
Respiratory Tract Diseases
Lung Diseases
Therapeutic Uses
Anti-Ulcer Agents
Hypersensitivity, Immediate
Respiratory Hypersensitivity

ClinicalTrials.gov processed this record on February 08, 2010