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

January 22, 2014 updated by: AstraZeneca

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

The purpose of this study is to investigate the efficacy, safety and tolerability of 4 weeks treatment with AZD3199 in moderate to severe COPD.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

329

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bulgaria
      • Blagoevgrad, Bulgaria
        • Research Site
      • Pleven, Bulgaria
        • Research Site
      • Russe, Bulgaria
        • Research Site
      • Sofia, Bulgaria
        • Research Site
      • Varna, Bulgaria
        • Research Site
  • Canada
    • New Brunswick
      • Moncton, New Brunswick, Canada
        • Research Site
    • Newfoundland and Labrador
      • St. John's, Newfoundland and Labrador, Canada
        • Research Site
    • Nova Scotia
      • Truro, Nova Scotia, Canada
        • Research Site
    • Ontario
      • Mississauga, Ontario, Canada
        • Research Site
      • Sudbury, Ontario, Canada
        • Research Site
      • Toronto, Ontario, Canada
        • Research Site
    • Quebec
      • Pointe-claire, Quebec, Canada
        • Research Site
      • Saint-romuald, Quebec, Canada
        • Research Site
      • Trois Rivieres, Quebec, Canada
        • Research Site
  • Japan
      • Kitakyusyu, Japan
        • Research Site
      • Osaka, Japan
        • Research Site
    • Fukuoka
      • Yanagawa, Fukuoka, Japan
        • Research Site
    • Hiroshima
      • Fukuyama, Hiroshima, Japan
        • Research Site
    • Hokkaido
      • Chitose, Hokkaido, Japan
        • Research Site
      • Obihiro, Hokkaido, Japan
        • Research Site
      • Tomakomai, Hokkaido, Japan
        • Research Site
    • Ibaragi
      • Hitachi, Ibaragi, Japan
        • Research Site
    • Ibaraki
      • Naka-gun, Ibaraki, Japan
        • Research Site
    • Miyagi
      • Sendai, Miyagi, Japan
        • Research Site
    • Osaka
      • Toyonaka, Osaka, Japan
        • Research Site
    • Shiga
      • Moriyama, Shiga, Japan
        • Research Site
      • Otsu, Shiga, Japan
        • Research Site
    • Tokyo
      • Machida, Tokyo, Japan
        • Research Site
  • Poland
      • BIAlYSTOK, Poland
        • Research Site
      • Gorzow Wlkp, Poland
        • Research Site
      • Lodz, Poland
        • Research Site
      • Lublin, Poland
        • Research Site
      • POZNAn, Poland
        • Research Site
      • Szczecin, Poland
        • Research Site
      • Tarnow, Poland
        • Research Site
  • Russian Federation
      • Moscow, Russian Federation
        • Research Site
      • Novosibirsk, Russian Federation
        • Research Site
      • St. Petersburg, Russian Federation
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • COPD
  • Current or exsmokers, 10 pack years

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: 5
Placebo
Drug: Placebo
Dry powder for inhalation, b.i.d., 4 weeks
Experimental: 1
AZD3199 low dose
Drug: AZD3199
Dry powder for inhalation, o.d., 4 weeks
Experimental: 2
AZD3199 intermediate dose
Drug: AZD3199
Dry powder for inhalation, o.d., 4 weeks
Experimental: 3
AZD3199 high dose
Drug: AZD3199
Dry powder for inhalation, o.d., 4 weeks
Active Comparator: 4
Formoterol 2x4.5 microgram bid
Drug: formoterol
Dry powder for inhalation, b.i.d., 4 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
0,5 min, 15 min, 60 min, 2 h, 4 h
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
24h, 26h

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cmax; the Highest Plasma Concentration of AZD3199 Measured
Time Frame: 0,15 min, 1, 4 and 24 hours post dose
PK is only measured for AZD3199
0,15 min, 1, 4 and 24 hours post dose
AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose
Time Frame: 0,15 min, 1, 4 and 24 hours post dose
PK is only measured for AZD3199
0,15 min, 1, 4 and 24 hours post dose
FEV1 Post Salbutamol Inhalation
Time Frame: 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
Baseline (visit 2) and 26 h after the last morning dose (visit 5).
Total Number of Reliever Medication Inhalations Per 24h
Time Frame: 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
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.
Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)
Time Frame: 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.
Daily, during run-in and treatment
Overall Mean CCQ (Clinical COPD Questionnaire)
Time Frame: 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.
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)
Time Frame: 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)
At baseline (visit 2) and after 4 weeks of treatment (visit 5).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Piotr Kuna, Professor, University Hospital, Lodz, Poland

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2009

Primary Completion (Actual)

March 1, 2010

Study Completion (Actual)

March 1, 2010

Study Registration Dates

First Submitted

June 26, 2009

First Submitted That Met QC Criteria

June 26, 2009

First Posted (Estimate)

June 29, 2009

Study Record Updates

Last Update Posted (Estimate)

February 17, 2014

Last Update Submitted That Met QC Criteria

January 22, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D0570C00003

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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