Phase 2
Completed N=1,144
Investigation of Efficacy, Safety and Tolerability of Once and Twice Daily Doses of AZD1981 in Asthmatic Patients
Asthma Patients
Source: ClinicalTrials.gov NCT01197794 ↗
Enrolled (actual)
1,144
Serious AEs
0.5%
Results posted
Sep 2013
Primary outcomePrimary: Pre-bronchodilator FEV1 at the Clinic — 0.16; 0.19; 0.19; 0.15 Liters
Summary
The study will assess the efficacy, safety and tolerability of AZD1981 compared to non-active compound in asthmatic patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Pre-bronchodilator FEV1 at the Clinic |
0.16; 0.19; 0.19; 0.15; 0.20; 0.15 | — |
| SECONDARY Morning and Evening PEF |
5.80; 0.60; 4.70; 0.06; 9.36; 0.36 | — |
| SECONDARY Asthma Control Questionnaire 5-item (ACQ5) |
-0.88; -0.88; -0.87; -0.90; -0.98; -0.83 | — |
| SECONDARY Adverse Events |
46; 46; 46; 40; 49; 56 | — |
| SECONDARY Number of Participants With at Least One Severe Asthma Exacerbation |
4; 3; 7; 7; 5; 6 | — |
| SECONDARY Number of Participants With at Least One Treatment Failure |
4; 9; 3; 8; 10; 12 | — |
| SECONDARY Number of Participants With Well-controlled Asthma (ACQ5<=0.75) |
34; 33; 34; 34; 36; 30 | — |
| SECONDARY Asthma Quality of Life Questionnaire (AQLQ(S)) |
0.73; 0.73; 0.75; 0.80; 0.82; 0.72 | — |
| SECONDARY Asthma Symptom Score |
-0.30; -0.26; -0.28; -0.33; -0.34; -0.30 | — |
| SECONDARY Total Reliever Medication Use |
-0.51; -0.22; -0.38; -0.39; -0.37; -0.37 | — |
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
Data sourced from ClinicalTrials.gov (NCT01197794). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.