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

June 26, 2009
January 22, 2014
June 2009
March 2010   (final data collection date for primary outcome measure)
  • 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
FEV1 [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00929708 on ClinicalTrials.gov Archive Site
  • 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)
  • Pharmacokinetics [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ]
  • Clinical significant abnormalities in ECG, pulse, blood pressure, lung function, temp, lab [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ]
  • Incidence and nature of Adverse Events [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ]
Not Provided
Not Provided
 
Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients
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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
COPD
  • Drug: AZD3199
    Dry powder for inhalation, o.d., 4 weeks
  • Drug: formoterol
    Dry powder for inhalation, b.i.d., 4 weeks
  • Drug: Placebo
    Dry powder for inhalation, b.i.d., 4 weeks
  • Experimental: 1
    AZD3199 low dose
    Intervention: Drug: AZD3199
  • Experimental: 2
    AZD3199 intermediate dose
    Intervention: Drug: AZD3199
  • Experimental: 3
    AZD3199 high dose
    Intervention: Drug: AZD3199
  • Active Comparator: 4
    Formoterol 2x4.5 microgram bid
    Intervention: Drug: formoterol
  • Placebo Comparator: 5
    Placebo
    Intervention: Drug: Placebo
Kuna P, Ivanov Y, Trofimov VI, Saito T, Beckman O, Bengtsson T, Jorup C, Maltais F. Efficacy and safety of AZD3199 vs formoterol in COPD: a randomized, double-blind study. Respir Res. 2013 Jun 3;14:64. doi: 10.1186/1465-9921-14-64.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
329
March 2010
March 2010   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • COPD
  • Current or exsmokers, 10 pack years

Exclusion Criteria:

  • Asthma
  • Any clinically relevant abnormal findings at screening examinations
  • Recent COPD exacerbation
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada,   Bulgaria,   Russian Federation,   Japan,   Poland
 
NCT00929708
D0570C00003
No
AstraZeneca
AstraZeneca
Not Provided
Principal Investigator: Piotr Kuna, Professor University Hospital, Lodz, Poland
AstraZeneca
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP