Phase 2
N=329
Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients
COPD
Bottom Line
View on ClinicalTrials.gov: NCT00929708 ↗Enrolled (actual)
329
Serious AEs
3.0%
Results posted
Jan 2014
Primary outcome: Primary: FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect) — 0.21; 0.17; 0.14; 0.16 Litre
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- AZD3199 (Drug); formoterol (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 40+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Mar 2010
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect) |
0.21; 0.17; 0.14; 0.16; 0.03 | — |
| PRIMARY FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect) |
0.11; 0.12; 0.11; 0.03; 0.01 | — |
| SECONDARY Cmax; the Highest Plasma Concentration of AZD3199 Measured |
1.14; 1.88; 4.01 | — |
| SECONDARY AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose |
4.83; 8.69; 14.82 | — |
| SECONDARY FEV1 Post Salbutamol Inhalation |
0.060; 0.073; 0.077; 0.048; 0.018 | — |
| SECONDARY Total Number of Reliever Medication Inhalations Per 24h |
-0.96; -1.23; -1.15; -0.66; -0.23 | — |
| SECONDARY Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings) |
-0.96; -0.91; -1.21; -0.56; -0.43 | — |
| SECONDARY Overall Mean CCQ (Clinical COPD Questionnaire) |
-0.39; -0.29; -0.39; -0.35; -0.10 | — |
| SECONDARY Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD) |
-5.10; -8.17; -5.01; -5.16; -2.35 | — |
Summary
The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.
Eligibility Criteria
Inclusion Criteria
- COPD
- Current or exsmokers, 10 pack years
Exclusion Criteria
- Asthma
- Any clinically relevant abnormal findings at screening examinations
- Recent COPD exacerbation
Data sourced from ClinicalTrials.gov (NCT00929708). 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.