Clinical trial NCT00758589: One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-09-25
Enrollment: 368
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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


Eligibility criteria: 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

Primary outcomes:
measure: Morning Peak Expiratory Flow (mPEF)
timeFrame: Week 4
Secondary outcomes:
measure: Evening Peak Expiratory Flow (ePEF)
timeFrame: Week 4
measure: Morning Forced Expiratory Volume in 1 Second (mFEV1)
timeFrame: Week 4
measure: Evening Forced Expiratory Volume in 1 Second (eFEV1)
timeFrame: Week 4
measure: Total Use of Reliever
timeFrame: Week 4
measure: Night-time Asthma Symptom Score
timeFrame: Week 4
measure: Day-time Asthma Symptom Score
timeFrame: Week 4
measure: Awakenings
timeFrame: Week 4
measure: Asthma Control Day
timeFrame: Week 4
measure: Symptom Free Day
timeFrame: Week 4
measure: Reliever Free Day
timeFrame: Week 4
measure: Forced Expiratory Volume in 1 Second (FEV1) at the Clinic
timeFrame: Week 4
measure: Forced Vital Capacity (FVC) at the Clinic
timeFrame: Week 4
measure: Asthma Control Questionnaire 5 Items (ACQ5)
timeFrame: Week 4
measure: Adverse Event (AE)
timeFrame: 4 weeks
Other outcomes:
Locations:
city: Quilmes
country: Argentina
facility: Research Site
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
state: Tucuman
city: Buenos Aires
country: Argentina
facility: Research Site
city: Santa Fe
country: Argentina
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
state: Brasil
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Santo Andre
country: Brazil
facility: Research Site
state: SP
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Barrio Los Yoses
country: Costa Rica
facility: Research Site
state: San Jose
city: San Francisco de Dos Rios
country: Costa Rica
facility: Research Site
state: San Jose
city: Bialystok
country: Poland
facility: Research Site
city: Bydgoszcz
country: Poland
facility: Research Site
city: Gdalsk
country: Poland
facility: Research Site
city: Kielce
country: Poland
facility: Research Site
city: Krakow
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: Poznal
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Tarnow
country: Poland
facility: Research Site
city: Turek
country: Poland
facility: Research Site
city: Wroclaw
country: Poland
facility: Research Site
Study officials:
affiliation: University of Lodz, Lodz, Poland
name: Piotr Kuna
role: PRINCIPAL_INVESTIGATOR
References: