Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients

Phase 2

Completed

• Conditions: COPD
• Interventions: Drug: AZD3199; Drug: formoterol; Drug: Placebo

• Registration Number: NCT00929708
• Lead Sponsor: AstraZeneca

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2009-06
• Study First Submitted: 2009-06-26
• Study First Submitted QC: 2009-06-26
• Study First Posted: 2009-06-29
• Primary Completion: 2010-03
• Study Completion: 2010-03
• Results First Submitted: 2012-12-20
• Results First Submitted QC: 2013-12-16
• Status Verified: 2014-01
• Results First Posted: 2014-01-17
• Last Update Submitted: 2014-01-22
• Last Update Posted: 2014-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 329

Inclusion Criteria

• COPD
• Current or exsmokers, 10 pack years

Exclusion Criteria

• Asthma
• Any clinically relevant abnormal findings at screening examinations
• Recent COPD exacerbation

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	AZD3199	AZD3199 low dose
2	AZD3199	AZD3199 intermediate dose
3	AZD3199	AZD3199 high dose
4	formoterol	Formoterol 2x4.5 microgram bid
5	Placebo	Placebo

Primary Outcome Measures

Name	Time	Method
FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)	0,5 min, 15 min, 60 min, 2 h, 4 h	change from baseline
FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)	24h, 26h	change from baseline

Secondary Outcome Measures

Name	Time	Method
FEV1 Post Salbutamol Inhalation	Baseline (visit 2) and 26 h after the last morning dose (visit 5).	Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5
Cmax; the Highest Plasma Concentration of AZD3199 Measured	0,15 min, 1, 4 and 24 hours post dose	PK is only measured for AZD3199
Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)	Daily, during run-in and treatment	Score on a scale 5-point Likert-type scale, ranging from 0 (none) to 4 (severe) for each symptom, total score is the sum of each symptom ranged from 0 to 16. Change from run-in.
AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose	0,15 min, 1, 4 and 24 hours post dose	PK is only measured for AZD3199
Overall Mean CCQ (Clinical COPD Questionnaire)	Mean over week 0, mean over week 1, mean over week 2, and mean over week 4	Change from baseline to treatment in score. The total scores vary between 0 (never/not limited at all) to 6 (almost all the time/totally limited). The data below represent the average of week 1,2,4 minus week 0.
Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD)	At baseline (visit 2) and after 4 weeks of treatment (visit 5).	The total score is calculated using all questions including their weights and scores range from 0 (perfect health) to 100 (worst possible state)
Total Number of Reliever Medication Inhalations Per 24h	During day (from rising from bed until going to bed) and night (from going to bed until rising from bed) at visit 1 to visit 5 (24h), up to 4 weeks.	Change from run-in

Trial Locations

Locations (1)

Research Site; 🇷🇺 St. Petersburg, Russian Federation