Phase 2
Completed N=838
A Dose Range Finding Study to Evaluate the Efficacy and Safety of AZD9668 Administered Orally at Three Dose Levels to Patients With Chronic Obstructive Pulmonary Disease (COPD) on Treatment With Tiotropium
Source: ClinicalTrials.gov NCT00949975 ↗Enrolled (actual)
838
Serious AEs
5.4%
Results posted
Aug 2012
Primary outcomePrimary: Baseline Pre-bronchodilator FEV1 (L) — 1.51; 1.47; 1.50; 1.51 L
Summary
The primary objective is to evaluate the dose-response relationship and efficacy of AZD9668 at 3 dose levels compared with placebo in symptomatic COPD patients by assessing effects on lung function and symptoms of COPD.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Pre-bronchodilator FEV1 (L) |
1.51; 1.47; 1.50; 1.51 | — |
| PRIMARY End-value Pre-bronchodilator FEV1 (L) |
1.51; 1.47; 1.46; 1.47 | — |
| SECONDARY Post-bronchodilator FEV1 (L) - Baseline |
1.68; 1.64; 1.65; 1.69 | — |
| SECONDARY Post-bronchodilator FEV1 (L) - End-value |
1.66; 1.63; 1.63; 1.62 | — |
| SECONDARY Pre-bronchodilator FVC (L) - Baseline |
3.08; 3.01; 3.06; 3.04 | — |
| SECONDARY Pre-bronchodilator FVC (L) - End-value |
3.08; 3.05; 3.02; 3.02 | — |
| SECONDARY Post-bronchodilator FVC (L) - Baseline |
3.30; 3.24; 3.24; 3.27 | — |
| SECONDARY Post-bronchodilator FVC (L) - End-value |
3.28; 3.26; 3.24; 3.22 | — |
| SECONDARY Pre-bronchodilator IC (L) - Baseline |
2.22; 2.14; 2.15; 2.17 | — |
| SECONDARY Pre-bronchodilator IC (L) - End-value |
2.15; 2.15; 2.16; 2.15 | — |
| SECONDARY Post-bronchodilator IC (L) - Baseline |
2.37; 2.30; 2.28; 2.32 | — |
| SECONDARY Post-bronchodilator IC (L) - End-value |
2.29; 2.30; 2.31; 2.30 | — |
| SECONDARY PEF - Baseline Measured by Patient at Home (L/Min) in the Morning |
222.33; 219.86; 216.99; 221.79 | — |
| SECONDARY PEF - End-value Measured by Patient at Home (L/Min) in the Morning |
214.30; 214.55; 212.35; 220.47 | — |
| SECONDARY FEV1 - Baseline Measured by Patient at Home (L) in the Morning |
1.40; 1.34; 1.36; 1.38 | — |
| SECONDARY FEV1 - End-value Measured by Patient at Home (L) in the Morning |
1.36; 1.35; 1.33; 1.34 | — |
| SECONDARY EXACT - Baseline Total Score |
43.17; 42.38; 42.37; 40.95 | — |
| SECONDARY EXACT - End-value Total Score |
39.97; 39.72; 40.59; 39.71 | — |
| SECONDARY BCSS - Baseline Total Score |
4.85; 4.66; 4.79; 4.48 | — |
| SECONDARY BCSS - End-value Total Score |
4.09; 4.03; 4.25; 4.20 | — |
| SECONDARY Sputum Colour - Baseline |
2.15; 2.34; 2.13; 2.16 | — |
| SECONDARY Sputum Colour - End Value |
2.11; 2.03; 2.20; 2.11 | — |
| SECONDARY Use of Reliever Medication |
4.28; 4.20; 4.65; 4.56 | — |
| SECONDARY Six-minute Walk Test - Distance Walked at Baseline (m) |
386.2; 402.2; 384.9; 386.0 | — |
| SECONDARY Six-minute Walk Test - End-value Distance Walked (m) |
396.7; 397.8; 411.2; 409.5 | — |
| SECONDARY St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline |
53.98; 51.98; 52.97; 51.41 | — |
| SECONDARY St George's Respiratory Questionnaire (COPD) - End-value Overall Score |
49.50; 49.49; 47.93; 46.35 | — |
| SECONDARY Exacerbations - Clinic Defined |
29; 28; 34; 29 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COPD with symptoms over 1 year
- Smokers or ex-smokers
- Males or post-menopausal females between 40 and 80 years old
- Able to use electronic devices
Exclusion Criteria
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Patients who require long term oxygen therapy
- Treatment with antibiotics within 4 weeks of study visit 1b
Data sourced from ClinicalTrials.gov (NCT00949975). 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.