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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00929708
First Posted: June 29, 2009
Last Update Posted: February 17, 2014
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.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
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 Intervention Phase
COPD Drug: AZD3199 Drug: formoterol Drug: Placebo Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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

  • 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

  • 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

  • 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

  • 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.

  • 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.

  • 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)


Enrollment: 329
Study Start Date: June 2009
Study Completion Date: March 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

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.


Ages Eligible for Study:   40 Years and older   (Adult, Senior)
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
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


  Show 38 Study Locations
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Piotr Kuna, Professor University Hospital, Lodz, Poland
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00929708     History of Changes
Other Study ID Numbers: D0570C00003
First Submitted: June 26, 2009
First Posted: June 29, 2009
Results First Submitted: December 20, 2012
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:
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Lung Diseases
Respiratory Tract Diseases
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