Clinical Trials/NCT00929708

NCT00929708

Completed

Phase 2

A 4-week, Phase-II, Double-blind, Placebo-controlled, Randomised, Parallel-group, Multi-centre Study to Assess the Efficacy and Tolerability/Safety of Inhaled AZD3199 Once Daily Compared to 9 μg Formoterol Bid and Placebo in Patients With Moderate to Severe COPD

AstraZeneca1 site in 1 country329 target enrollmentJune 2009

ConditionsCOPD

InterventionsAZD3199 formoterol Placebo

DrugsAZD3199 formoterol Placebo

Overview

Phase: Phase 2
Intervention: AZD3199
Conditions: COPD
Sponsor: AstraZeneca
Enrollment: 329
Locations: 1
Primary Endpoint: FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)
Status: Completed
Last Updated: 12 years ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 2009

End Date

March 2010

Last Updated

12 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

AstraZeneca

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Current or exsmokers, 10 pack years

Exclusion Criteria

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

Arms & Interventions

1

AZD3199 low dose

Intervention: AZD3199

2

AZD3199 intermediate dose

Intervention: AZD3199

3

AZD3199 high dose

Intervention: AZD3199

4

Formoterol 2x4.5 microgram bid

Intervention: formoterol

5

Placebo

Intervention: Placebo

Outcomes

Primary Outcomes

FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)

Time Frame: 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)

Time Frame: 24h, 26h

change from baseline

Secondary Outcomes

FEV1 Post Salbutamol Inhalation(Baseline (visit 2) and 26 h after the last morning dose (visit 5).)
Cmax; the Highest Plasma Concentration of AZD3199 Measured(0,15 min, 1, 4 and 24 hours post dose)
Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)(Daily, during run-in and treatment)
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)
Overall Mean CCQ (Clinical COPD Questionnaire)(Mean over week 0, mean over week 1, mean over week 2, and mean over week 4)
Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD)(At baseline (visit 2) and after 4 weeks of treatment (visit 5).)
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.)