NCT01197794
Completed
Phase 2
A Double-blind, Placebo-controlled, Randomised, Parallel-group, Phase II, Multi-centre Study to Assess the Efficacy, Safety and Tolerability of 4 Twice Daily Doses and 2 Once Daily Doses of AZD1981 Given as Tablets During 12 Weeks in Asthmatic Patients
Overview
- Phase
- Phase 2
- Intervention
- AZD1981
- Conditions
- Asthma Patients
- Sponsor
- AstraZeneca
- Enrollment
- 1144
- Locations
- 1
- Primary Endpoint
- Pre-bronchodilator FEV1 at the Clinic
- Status
- Completed
- Last Updated
- 12 years ago
Overview
Brief Summary
The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Men and women. Women must be surgically sterilized/postmenopausal or use double barrier method contraception
- •6 months history of asthma according to ATS definition
- •Prescribed daily dose of ICS and LABA for at least 3 months prior to Visit 2
- •Pre-bronchodilator FEV1 of 40 to 85 % of predicted normal
- •A total ACQ5 score of 1.5 or more
Exclusion Criteria
- •Respiratory infection significantly affecting the asthma
- •Any significant disease and disorder that may put the patient at risk or influence study results
- •Any clinically relevant abnormal findings
- •A smoking history of more than 10 pack years
- •Intake of oral, rectal or parenteral glucocorticosteroids
Arms & Interventions
AZD1981 10 mg
AZD1981 10 mg
Intervention: AZD1981
AZD1981 40 mg
AZD1981 40 mg
Intervention: AZD1981
AZD1981 100 mg
AZD1981 100 mg
Intervention: AZD1981
AZD1981 400 mg
AZD1981 400 mg
Intervention: AZD1981
AZD1981 80 mg
AZD1981 80 mg
Intervention: AZD1981
AZD1981 200 mg
AZD1981 200 mg
Intervention: AZD1981
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Pre-bronchodilator FEV1 at the Clinic
Time Frame: Twelve week treatment period
Change from baseline: treatment period average minus baseline. Treatment period average defined as the mean of all available data during randomized treatment that occurred on or prior to treatment failure. Treatment failure defined as worsening asthma symptoms resulting in increased dose of inhaled corticosteroid.
Secondary Outcomes
- Morning and Evening PEF(Twelve week treatment period)
- Asthma Control Questionnaire 5-item (ACQ5)(Twelve week treatment period)
- Adverse Events(Twelve week treatment period)
- Number of Participants With at Least One Severe Asthma Exacerbation(Twelve week treatment period)
- Number of Participants With at Least One Treatment Failure(Twelve week treatment period)
- Number of Participants With Well-controlled Asthma (ACQ5<=0.75)(Twelve week treatment period)
- Asthma Quality of Life Questionnaire (AQLQ(S))(Twelve week treatment period)
- Asthma Symptom Score(Twelve week treatment period)
- Total Reliever Medication Use(Twelve week treatment period)
Study Sites (1)
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