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


Tracking Information

Start Date  ICMJEJune 2009
Primary Completion Date 
Current Primary Outcome Measures  ICMJE 
 (submitted: June 26, 2009)		FEV1 [ Time Frame: Before, during and after dosing ] [ Designated as safety issue: No ]
Original Primary Outcome Measures  ICMJESame as current
Change HistoryComplete list of historical versions of study NCT00929708 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE 
 (submitted: June 26, 2009)
  • 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 ]
Original Secondary Outcome Measures  ICMJESame as current

Descriptive Information

Brief Title  ICMJEEfficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients
Official Title  ICMJEA 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
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.

Detailed Description 
Study PhasePhase II
Study Type  ICMJEInterventional
Study Design  ICMJETreatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Parallel Assignment, Efficacy Study
Condition  ICMJECOPD
Intervention  ICMJE
  • 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
Study Arms / Comparison Groups
  • 1: Experimental
    AZD3199 low dose
    Intervention: Drug: AZD3199
  • 2: Experimental
    AZD3199 intermediate dose
    Intervention: Drug: AZD3199
  • 3: Experimental
    AZD3199 high dose
    Intervention: Drug: AZD3199
  • 4: Active Comparator
    Formoterol 2x4.5 microgram bid
    Intervention: Drug: formoterol
  • 5: Placebo Comparator
    Placebo
    Intervention: Drug: Placebo

Recruitment Information

Estimated Enrollment  ICMJE500
Estimated Completion DateMarch 2010
Primary Completion Date 
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • COPD
  • Current or exsmokers, 10 pack years

Exclusion Criteria:

  • Asthma
  • Any clinically relevant abnormal findings at screening examinations
  • Recent COPD exacerbation
GenderBoth
Ages40 Years and older
Accepts Healthy VolunteersNo
Contacts  ICMJE
Contact: AstraZeneca Clinical Study Information AstraZeneca Clinical Study Information800-236-9933information.center@astrazeneca.com
Contact: Clinical Study Patients www.clinicalstudypatient.ca
Location Countries  ICMJEBulgaria,   Canada,   Japan,   Poland,   Russian Federation

Administrative Information

NCT ID  ICMJENCT00929708
Responsible PartyCarin Jorup, MD, Medical Science Director, Emerging Respiratory 3, AstraZeneca R&D
Study ID Numbers  ICMJED0570C00003
Study Sponsor  ICMJEAstraZeneca
Collaborators  ICMJE 
Investigators  ICMJE
Principal Investigator:Piotr Kuna, ProfessorUniversity Hospital, Lodz, Poland
Information Provided ByAstraZeneca