Phase 2
Completed N=368
One Month Dose Response Study of AZD1981 in Asthma Patients Uncontrolled on Inhaled Steroids
Source: ClinicalTrials.gov NCT00758589 ↗Enrolled (actual)
368
Serious AEs
0.5%
Results posted
Dec 2013
Primary outcomePrimary: Morning Peak Expiratory Flow (mPEF) — 346.42; 362.54; 352.87; 329.75 L/min
Summary
The primary objective of this study is to evaluate efficacy of AZD1981 in uncontrolled asthmatic patients on maintenance inhaled glucocorticosteroids.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Morning Peak Expiratory Flow (mPEF) |
346.42; 362.54; 352.87; 329.75 | — |
| SECONDARY Evening Peak Expiratory Flow (ePEF) |
359.83; 378.98; 368.70; 348.87 | — |
| SECONDARY Morning Forced Expiratory Volume in 1 Second (mFEV1) |
2.45; 2.65; 2.53; 2.31 | — |
| SECONDARY Evening Forced Expiratory Volume in 1 Second (eFEV1) |
2.47; 2.72; 2.63; 2.43 | — |
| SECONDARY Total Use of Reliever |
2.870; 2.640; 2.569; 2.855 | — |
| SECONDARY Night-time Asthma Symptom Score |
0.998; 0.881; 0.912; 1.008 | — |
| SECONDARY Day-time Asthma Symptom Score |
1.037; 0.933; 0.995; 1.105 | — |
| SECONDARY Awakenings |
38.59; 33.18; 33.34; 37.32 | — |
| SECONDARY Asthma Control Day |
10.78; 7.48; 13.23; 10.08 | — |
| SECONDARY Symptom Free Day |
17.33; 13.95; 15.56; 14.31 | — |
| SECONDARY Reliever Free Day |
22.59; 20.60; 24.13; 20.94 | — |
| SECONDARY Forced Expiratory Volume in 1 Second (FEV1) at the Clinic |
2.653; 2.739; 2.628; 2.400 | — |
| SECONDARY Forced Vital Capacity (FVC) at the Clinic |
3.704; 3.892; 3.546; 3.563 | — |
| SECONDARY Asthma Control Questionnaire 5 Items (ACQ5) |
1.69; 1.58; 1.64; 1.91 | — |
| SECONDARY Adverse Event (AE) |
28; 22; 33; 24 | — |
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
Data sourced from ClinicalTrials.gov (NCT00758589). 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.