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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00929708
First received: June 26, 2009
Last updated: January 22, 2014
Last verified: January 2014
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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. ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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). ] [ Designated as safety issue: No ]
    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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00929708

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

No publications provided by AstraZeneca

Additional 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
Study First Received: June 26, 2009
Results First Received: December 20, 2012
Last Updated: January 22, 2014
Health Authority: Bulgaria: Bulgarian Drug Agency
Canada: Health Canada
Japan: Pharmaceuticals and Medical Devices Agency
Poland: Ministry of Health
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: Ministry of Health of the Russian Federation

Keywords provided by AstraZeneca:
COPD
Efficacy
Safety
Inhalation

Additional relevant MeSH terms:
Lung Diseases
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Formoterol
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 15, 2014