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NCT00628953 Clinical Trial

Adult Asthmatics and Acid Reflux

Asthma Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00628953
Other study ID # SD-NEE-0003
Secondary ID D9611C00003
Status Completed
Phase Phase 2
First received February 26, 2008
Last updated March 12, 2009
Start date October 2002
Est. completion date April 2004

Study information
Verified date March 2009
Source AstraZeneca
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug AdministrationArgentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBulgaria: Ministry of HealthBrazil: Ministry of HealthCanada: Health CanadaCzech Republic: State Institute for Drug ControlFinland: Finnish Medicines AgencyUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyHungary: National Institute of PharmacyItaly: Ministry of HealthMexico: Ministry of HealthRomania: National Medicines AgencySouth Africa: Department of Health
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 1400
Est. completion date April 2004
Est. primary completion date April 2004
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 70 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Esomeprazole
40mg twice a day
• Placebo
40mg twice a day

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
AstraZeneca

Outcome
Type Measure Description Time frame Safety issue
Primary Effect on asthma symptoms as measured by changes in Peak Expiratory Flow morning & evening, Forced Expiratory Volume and asthma symptom scores 4 weekly
Secondary Safety as assessed by adverse event recording and clinical and laboratory measurements. 4 weekly
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