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
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, see Learn About Clinical Studies.

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

ClinicalTrials.gov processed this record on October 20, 2014