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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
329

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
AstraZeneca

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 26, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 26, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 29, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 17, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 22, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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