Phase 2
Completed N=615
Efficacy and Safety of Twice Daily 60mg AZD9668 in COPD for 12 Weeks in Patients on Background Budesonide/Formoterol
Source: ClinicalTrials.gov NCT01023516 ↗Enrolled (actual)
615
Serious AEs
3.7%
Results posted
Aug 2012
Primary outcomePrimary: Baseline Pre-bronchodilator FEV1 (L) — 1.49; 1.44 L
Summary
The primary objective is to evaluate the efficacy of AZD9668 compared with placebo in symptomatic COPD patients by assessing the effects on lung function and symptoms of COPD
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Baseline Pre-bronchodilator FEV1 (L) |
1.49; 1.44 | — |
| PRIMARY End-value Pre-bronchodilator FEV1 (L) |
1.45; 1.43 | — |
| SECONDARY Post-bronchodilator FEV1 (L) - Baseline |
1.59; 1.56 | — |
| SECONDARY Post-bronchodilator FEV1 (L) - End-value |
1.56; 1.54 | — |
| SECONDARY Pre-bronchodilator FVC (L) - Baseline |
2.98; 2.94 | — |
| SECONDARY Pre-bronchodilator FVC (L) - End-value |
2.94; 2.93 | — |
| SECONDARY Post-bronchodilator FVC (L) - Baseline |
3.16; 3.12 | — |
| SECONDARY Post-bronchodilator FVC (L) - End-value |
3.11; 3.11 | — |
| SECONDARY Baseline Pre-bronchodilator FEV6 (L) |
2.68; 2.61 | — |
| SECONDARY End-value Pre-bronchodilator FEV6 (L) |
2.61; 2.61 | — |
| SECONDARY Baseline Post-bronchodilator FEV6 (L) |
2.85; 2.79 | — |
| SECONDARY End-value Post-bronchodilator FEV6 (L) |
2.77; 2.78 | — |
| SECONDARY Baseline Pre-bronchodilator FEF25-75% (L/Sec) |
0.60; 0.55 | — |
| SECONDARY End-value Pre-bronchodilator FEF25-75% (L/Sec) |
0.57; 0.56 | — |
| SECONDARY Baseline Post-bronchodilator FEF25-75% (L/Sec) |
0.64; 0.60 | — |
| SECONDARY End-value Post-bronchodilator FEF25-75% (L/Sec) |
0.62; 0.61 | — |
| SECONDARY Pre-bronchodilator IC (L) - Baseline |
2.21; 2.17 | — |
| SECONDARY Pre-bronchodilator IC (L) - End-value |
2.13; 2.14 | — |
| SECONDARY Post-bronchodilator IC (L) - Baseline |
2.33; 2.30 | — |
| SECONDARY Post-bronchodilator IC (L) - End-value |
2.30; 2.27 | — |
| SECONDARY PEF - Baseline Measured by Patient at Home (L/Min) in the Morning |
215.60; 213.24 | — |
| SECONDARY PEF - End-value Measured by Patient at Home (L/Min) in the Morning |
208.68; 211.93 | — |
| SECONDARY FEV1 - Baseline Measured by Patient at Home (L) in the Morning |
1.40; 1.34 | — |
| SECONDARY FEV1 - End-value Measured by Patient at Home (L) in the Morning |
1.32; 1.32 | — |
| SECONDARY EXACT - Baseline Total Score |
45.47; 46.01 | — |
| SECONDARY EXACT - End-value Total Score |
42.78; 43.07 | — |
| SECONDARY BCSS - Baseline Total Score |
5.26; 5.44 | — |
| SECONDARY BCSS - End-value Total Score |
4.68; 4.68 | — |
| SECONDARY Sputum Colour - Baseline |
1.87; 1.88 | — |
| SECONDARY Sputum Colour - End Value |
1.63; 1.70 | — |
| SECONDARY Use of Reliever Medication |
3.40; 3.37 | — |
| SECONDARY Incremental Shuttle Walk Test - Baseline |
351; 352 | — |
| SECONDARY Incremental Shuttle Walk Test - End Value |
363.6; 363.7 | — |
| SECONDARY Endurance Shuttle Walk Test - Baseline |
419; 449 | — |
| SECONDARY Endurance Shuttle Walk Test - End Value |
449.6; 459.9 | — |
| SECONDARY St George's Respiratory Questionnaire (COPD) - Overall Score at Baseline |
54.52; 54.87 | — |
| SECONDARY St George's Respiratory Questionnaire (COPD) - End-value Overall Score |
49.89; 50.66 | — |
| SECONDARY Exacerbations - Clinic Defined |
22; 29 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of COPD with symptoms over 1 year
- FEV1/FVC = 30 and < 80 % of predicted post-bronchodilator
- Symptomatic COPD for a total of 7 days in the two weeks prior to randomisation
- At least 1 COPD exacerbation from 4 weeks to 12 months before the screening visit
Exclusion Criteria
- Past history or current evidence of clinically significant heart disease
- Current diagnosis of asthma
- Patients who require long term oxygen therapy
- Worsening of COPD requiring treatment with antibiotics, an increase in inhaled steroid dose and/or oral steroids within 4 weeks of study visit 1b
Data sourced from ClinicalTrials.gov (NCT01023516). 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.