One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids

Asthma Clinical Trial

— OLIVE  

Official title:

A Double-blind, Randomised, Parallel Group, Multicentre Phase IIb, Placebo-Controlled, 1 Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00758589
• Other study ID #: D9830C00004
• Status: Completed
• Phase: Phase 2
• First received: September 23, 2008
• Last updated: January 24, 2014
• Start date: September 2008
• Est. completion date: July 2009

Study information

• Verified date: January 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaBrazil: National Health Surveillance AgencyPoland: Ministry of HealthCosta Rica: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 368
• Est. completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Six months history of asthma

• Daily use of inhaled glucocorticosteroids

• FEV1 40-85% of predicted normal

• Reversibility; increase in FEV1 more than 12% and 200 mL post-bronchodilator

Exclusion Criteria:

• Other clinically relevant disease or disorders

• History of smoking of more than 10 pack years

• Respiratory infection within 30 days

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• AZD1981
Oral tablet, 50 mg twice daily
• AZD1981
Oral tablet, 400 mg twice daily
• AZD1981
Oral tablet, 1000 mg twice daily
• Placebo

Locations

Country	Name	City	State
Argentina	Research Site	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	San Miguel de Tucuman	Tucuman
Argentina	Research Site	Santa Fe
Brazil	Research Site	Porto Alegre	Brasil
Brazil	Research Site	Rio de Janeiro	RJ
Brazil	Research Site	Santo Andre	SP
Brazil	Research Site	Sao Paulo	SP
Costa Rica	Research Site	Barrio Los Yoses	San Jose
Costa Rica	Research Site	San Francisco de Dos Rios	San Jose
Poland	Research Site	Bialystok
Poland	Research Site	Bydgoszcz
Poland	Research Site	Gdalsk
Poland	Research Site	Kielce
Poland	Research Site	Krakow
Poland	Research Site	Lublin
Poland	Research Site	Poznal
Poland	Research Site	Szczecin
Poland	Research Site	Tarnow
Poland	Research Site	Turek
Poland	Research Site	Wroclaw

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Brazil,  Costa Rica,  Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Morning Peak Expiratory Flow (mPEF)	Mean mPEF during the treatment period (mean of the last 2 weeks of the treatment period)	Week 4	No
Secondary	Evening Peak Expiratory Flow (ePEF)	Mean ePEF during the treatment period (mean of the last 2 weeks of the treatment period)	Week 4	No
Secondary	Morning Forced Expiratory Volume in 1 Second (mFEV1)	Mean mFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)	Week 4	No
Secondary	Evening Forced Expiratory Volume in 1 Second (eFEV1)	Mean eFEV1 during the treatment period (mean of the last 2 weeks of the treatment period)	Week 4	No
Secondary	Total Use of Reliever	Mean total reliever use during the treatment period (mean of the last 2 weeks of the treatment period)	Week 4	No
Secondary	Night-time Asthma Symptom Score	Mean night-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).	Week 4	No
Secondary	Day-time Asthma Symptom Score	Mean day-time asthma symptom score during the treatment period (mean of the last 2 weeks of the treatment period). Scores range from 0 (none) to 3 (bad).	Week 4	No
Secondary	Awakenings	Mean percentage of awakenings due to asthma symptoms during the treatment period (mean of the last 2 weeks of the treatment period)	Week 4	No
Secondary	Asthma Control Day	Mean percentage of asthma control days during the treatment period (mean of the last 2 weeks of the treatment period). An asthma control day is defined as a symptom-free day with no use of reliever medication during day and night. A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.	Week 4	No
Secondary	Symptom Free Day	Mean percentage of symptom free days during the treatment period (mean of the last 2 weeks of the treatment period). A symptom-free day is defined as a day and a night with no asthma symptoms and a day and night with no awakenings due to asthma symptoms.	Week 4	No
Secondary	Reliever Free Day	Mean percentage of reliever free days during the treatment period (mean of the last 2 weeks of the treatment period). A reliever free day is defined as a day and a night with no use of as-needed medication.	Week 4	No
Secondary	Forced Expiratory Volume in 1 Second (FEV1) at the Clinic	Mean FEV1 during the treatment period (mean value at Week 4)	Week 4	No
Secondary	Forced Vital Capacity (FVC) at the Clinic	Mean FVC during the treatment period (mean value at Week 4)	Week 4	No
Secondary	Asthma Control Questionnaire 5 Items (ACQ5)	Mean ACQ5 score during the treatment period (mean value at Week 4). Scores range from 0 (good) to 6 (poor control).	Week 4	No
Secondary	Adverse Event (AE)	Number of patients reporting at least one event	4 weeks	No