Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients
GLAD
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
1 other identifier
interventional
329
5 countries
38
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_2
Started Jun 2009
Shorter than P25 for phase_2
38 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2009
CompletedFirst Submitted
Initial submission to the registry
June 26, 2009
CompletedFirst Posted
Study publicly available on registry
June 29, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2010
CompletedResults Posted
Study results publicly available
January 17, 2014
CompletedFebruary 17, 2014
January 1, 2014
9 months
June 26, 2009
December 20, 2012
January 22, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)
change from baseline
0,5 min, 15 min, 60 min, 2 h, 4 h
FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)
change from baseline
24h, 26h
Secondary Outcomes (7)
Cmax; the Highest Plasma Concentration of AZD3199 Measured
0,15 min, 1, 4 and 24 hours post dose
AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose
0,15 min, 1, 4 and 24 hours post dose
FEV1 Post Salbutamol Inhalation
Baseline (visit 2) and 26 h after the last morning dose (visit 5).
Total Number of Reliever Medication Inhalations Per 24h
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.
Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)
Daily, during run-in and treatment
- +2 more secondary outcomes
Study Arms (5)
1
EXPERIMENTALAZD3199 low dose
2
EXPERIMENTALAZD3199 intermediate dose
3
EXPERIMENTALAZD3199 high dose
4
ACTIVE COMPARATORFormoterol 2x4.5 microgram bid
5
PLACEBO COMPARATORPlacebo
Interventions
Eligibility Criteria
You may qualify if:
- COPD
- Current or exsmokers, 10 pack years
You may not qualify if:
- Asthma
- Any clinically relevant abnormal findings at screening examinations
- Recent COPD exacerbation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AstraZenecalead
Study Sites (38)
Research Site
Blagoevgrad, Bulgaria
Research Site
Pleven, Bulgaria
Research Site
Rousse, Bulgaria
Research Site
Sofia, Bulgaria
Research Site
Varna, Bulgaria
Research Site
Moncton, New Brunswick, Canada
Research Site
St. John's, Newfoundland and Labrador, Canada
Research Site
Truro, Nova Scotia, Canada
Research Site
Greater Sudbury, Ontario, Canada
Research Site
Mississauga, Ontario, Canada
Research Site
Toronto, Ontario, Canada
Research Site
Pointe-Claire, Quebec, Canada
Research Site
Saint Romuald, Quebec, Canada
Research Site
Trois-Rivières, Quebec, Canada
Research Site
Yanagawa, Fukuoka, Japan
Research Site
Fukuyama, Hiroshima, Japan
Research Site
Chitose, Hokkaido, Japan
Research Site
Obihiro, Hokkaido, Japan
Research Site
Tomakomai, Hokkaido, Japan
Research Site
Hitachi, Ibaragi, Japan
Research Site
Naka-gun, Ibaraki, Japan
Research Site
Sendai, Miyagi, Japan
Research Site
Osaka, Osaka, Japan
Research Site
Toyonaka, Osaka, Japan
Research Site
Moriyama, Shiga, Japan
Research Site
Ōtsu, Shiga, Japan
Research Site
Machida, Tokyo, Japan
Research Site
Kitakyushu, Japan
Research Site
Bialystok, Poland
Research Site
Gorzow Wlkp, Poland
Research Site
Lodz, Poland
Research Site
Lublin, Poland
Research Site
Poznan, Poland
Research Site
Szczecin, Poland
Research Site
Tarnów, Poland
Research Site
Moscow, Russia
Research Site
Novosibirsk, Russia
Research Site
Saint Petersburg, Russia
Related Publications (1)
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(1):64. doi: 10.1186/1465-9921-14-64.
PMID: 23731768DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Carin Jorup, MSD
- Organization
- AstraZeneca
Study Officials
- PRINCIPAL INVESTIGATOR
Piotr Kuna, Professor
University Hospital, Lodz, Poland
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
June 26, 2009
First Posted
June 29, 2009
Study Start
June 1, 2009
Primary Completion
March 1, 2010
Study Completion
March 1, 2010
Last Updated
February 17, 2014
Results First Posted
January 17, 2014
Record last verified: 2014-01