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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

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

Status
Unknown
Phases
Phase 2
Study type
Interventional
Source
JPRN
Registry ID
JPRN-jRCT2080221485
Enrollment
Unknown
Registered
2011-06-20
Start date
2011-06-20
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Interventions

investigational material(s) Generic name etc : AZD1981 INN of investigational material : Therapeutic category code : 225 Bronchodilators Dosage and Administration for Investigational material : twice

Sponsors

AstraZeneca
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion 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

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

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026