Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00929708
Recruitment Status : Completed
First Posted : June 29, 2009
Results First Posted : January 17, 2014
Last Update Posted : February 17, 2014
Sponsor:
Information provided by (Responsible Party):
AstraZeneca

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
COPD Drug: AZD3199 Drug: formoterol Drug: Placebo Phase 2

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 329 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : June 2009
Actual Primary Completion Date : March 2010
Actual Study Completion Date : March 2010

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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
Placebo Comparator: 5
Placebo
 Drug: Placebo
Dry powder for inhalation, b.i.d., 4 weeks


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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.

  6. 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.

  7. 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)


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • COPD
  • Current or exsmokers, 10 pack years

Exclusion Criteria:

  • Asthma
  • Any clinically relevant abnormal findings at screening examinations
  • Recent COPD exacerbation
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00929708


Locations
Layout table for location information
Bulgaria
Research Site
Blagoevgrad, Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Russe, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Canada, New Brunswick
Research Site
Moncton, New Brunswick, Canada
Canada, Newfoundland and Labrador
Research Site
St. John's, Newfoundland and Labrador, Canada
Canada, Nova Scotia
Research Site
Truro, Nova Scotia, Canada
Canada, Ontario
Research Site
Mississauga, Ontario, Canada
Research Site
Sudbury, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Canada, Quebec
Research Site
Pointe-claire, Quebec, Canada
Research Site
Saint-romuald, Quebec, Canada
Research Site
Trois Rivieres, Quebec, Canada
Japan
Research Site
Yanagawa, Fukuoka, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Chitose, Hokkaido, Japan
Research Site
Obihiro, Hokkaido, Japan
Research Site
Tomakomai, Hokkaido, Japan
Research Site
Hitachi, Ibaragi, Japan
Research Site
Naka-gun, Ibaraki, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Toyonaka, Osaka, Japan
Research Site
Moriyama, Shiga, Japan
Research Site
Otsu, Shiga, Japan
Research Site
Machida, Tokyo, Japan
Research Site
Kitakyusyu, Japan
Research Site
Osaka, Japan
Poland
Research Site
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
Russian Federation
Research Site
Moscow, Russian Federation
Research Site
Novosibirsk, Russian Federation
Research Site
St. Petersburg, Russian Federation
Sponsors and Collaborators
AstraZeneca
Investigators
Layout table for investigator information
Principal Investigator: Piotr Kuna, Professor University Hospital, Lodz, Poland
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Layout table for additonal information
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00929708    
Other Study ID Numbers: D0570C00003
First Posted: June 29, 2009    Key Record Dates
Results First Posted: January 17, 2014
Last Update Posted: February 17, 2014
Last Verified: January 2014
Keywords provided by AstraZeneca:
COPD
Efficacy
Safety
Inhalation
Additional relevant MeSH terms:
Layout table for MeSH terms
Formoterol Fumarate
AZD-3199
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
 Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action