Phase 2
N=28
The Study Will Evaluate the Effect of AZD9164 in Patients With Chronic Obstructive Pulmonary Disease
Chronic Obstructive Pulmonary Disease
Bottom Line
View on ClinicalTrials.gov: NCT00939211 ↗Enrolled (actual)
28
Serious AEs
0.0%
Results posted
Aug 2011
Primary outcome: Primary: Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose — 1.71; 1.79; 1.72; 1.71 L
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD9164 (Drug); Tiotropium (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Nov 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Forced Expiratory Volume in One Second (FEV1), Peak Effect Within 0 - 24 Hours Post-dose |
1.71; 1.79; 1.72; 1.71; 1.63 | — |
| PRIMARY Forced Expiratory Volume in One Second (FEV1), Average Effect Over 22 - 26 Hours Post-dose |
1.58; 1.63; 1.62; 1.57; 1.52 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1), Average Effect Over 0 - 24 Hours Post Dose |
1.57; 1.63; 1.56; 1.58; 1.50 | — |
| SECONDARY Forced Expiratory Volume in One Second (FEV1), Effect at 15 Minutes Post-dose |
1.42; 1.30; 1.25; 1.55; 1.49 | — |
| SECONDARY Systolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose |
125.5; 127.9; 127.3; 128.0; 126.5 | — |
| SECONDARY Diastolic Blood Pressure, Average Effect Over 0 - 4 Hours Post-dose |
73.1; 75.6; 74.2; 74.8; 73.5 | — |
| SECONDARY Pulse, Average Effect Over 0 - 4 Hours Post-dose |
61.1; 62.9; 64.8; 60.2; 61.3 | — |
| SECONDARY Heart Rate, Average Effect Over 0 - 4 Hours Post-dose |
61.0; 62.8; 65.2; 61.1; 61.3 | — |
| SECONDARY QTcF, Average Effect Over 0 - 4 Hours Post-dose |
400; 399; 396; 401; 398 | — |
| SECONDARY Plasma AZD9164 Cmax |
0.529; 3.629; 20.02 | — |
| SECONDARY Plasma AZD9164 AUC0-24 |
2.90; 15.2; 58.1 | — |
Summary
Chronic Obstructive Pulmonary Disease (COPD) is a chronic respiratory condition with deteriorating lung function over the years. Patients with COPD experience symptoms of shortness of breath, cough and sputum production. This study is to assess the treatment effects after inhalation of three different single doses of AZD9164 (100, 400 and 1200 mcg) and one single dose of tiotropium (18 mcg). One dose of placebo will be given as comparator. 25 patients are to participate in the study and all will be recruited in Sweden. Each patient will visit the study doctor 9 times during the study, whereof 5 visits will be overnight visits. All examinations, treatment and the follow-up is free of charge.
Eligibility Criteria
Inclusion Criteria
- A clinical diagnosis of COPD
- FEV1 40 - 80% of the predicted normal value (post-bronchodilator) and post- bronchodilator FEV1/FVC < 70%
Exclusion Criteria
- Any clinically relevant abnormal findings at screening examinations
- Any clinically significant disease or disorder
Data sourced from ClinicalTrials.gov (NCT00939211). 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.