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

COPD Clinical Trial

— GLAD  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00929708
• Other study ID #: D0570C00003
• Status: Completed
• Phase: Phase 2
• First received: June 26, 2009
• Last updated: January 22, 2014
• Start date: June 2009
• Est. completion date: March 2010

Study information

• Verified date: January 2014
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Bulgaria: Bulgarian Drug AgencyCanada: Health CanadaJapan: Pharmaceuticals and Medical Devices AgencyPoland: Ministry of HealthPoland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Ministry of Health of the Russian Federation
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 329
• Est. completion date: March 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

Inclusion Criteria:

• COPD

• Current or exsmokers, 10 pack years

Exclusion Criteria:

• Asthma

• Any clinically relevant abnormal findings at screening examinations

• Recent COPD exacerbation

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• COPD
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• AZD3199
Dry powder for inhalation, o.d., 4 weeks
• formoterol
Dry powder for inhalation, b.i.d., 4 weeks
• Placebo
Dry powder for inhalation, b.i.d., 4 weeks

Locations

Country	Name	City	State
Bulgaria	Research Site	Blagoevgrad
Bulgaria	Research Site	Pleven
Bulgaria	Research Site	Russe
Bulgaria	Research Site	Sofia
Bulgaria	Research Site	Varna
Canada	Research Site	Mississauga	Ontario
Canada	Research Site	Moncton	New Brunswick
Canada	Research Site	Pointe-claire	Quebec
Canada	Research Site	Saint-romuald	Quebec
Canada	Research Site	St. John's	Newfoundland and Labrador
Canada	Research Site	Sudbury	Ontario
Canada	Research Site	Toronto	Ontario
Canada	Research Site	Trois Rivieres	Quebec
Canada	Research Site	Truro	Nova Scotia
Japan	Research Site	Chitose	Hokkaido
Japan	Research Site	Fukuyama	Hiroshima
Japan	Research Site	Hitachi	Ibaragi
Japan	Research Site	Kitakyusyu
Japan	Research Site	Machida	Tokyo
Japan	Research Site	Moriyama	Shiga
Japan	Research Site	Naka-gun	Ibaraki
Japan	Research Site	Obihiro	Hokkaido
Japan	Research Site	Osaka
Japan	Research Site	Otsu	Shiga
Japan	Research Site	Sendai	Miyagi
Japan	Research Site	Tomakomai	Hokkaido
Japan	Research Site	Toyonaka	Osaka
Japan	Research Site	Yanagawa	Fukuoka
Poland	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	Tarnow
Russian Federation	Research Site	Moscow
Russian Federation	Research Site	Novosibirsk
Russian Federation	Research Site	St. Petersburg

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Bulgaria,  Canada,  Japan,  Poland,  Russian Federation, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Primary	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	No
Secondary	Cmax; the Highest Plasma Concentration of AZD3199 Measured	PK is only measured for AZD3199	0,15 min, 1, 4 and 24 hours post dose	No
Secondary	AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose	PK is only measured for AZD3199	0,15 min, 1, 4 and 24 hours post dose	No
Secondary	FEV1 Post Salbutamol Inhalation	Mean value of FEV1 pre and post salbutamol at visit 2 and visit 5	Baseline (visit 2) and 26 h after the last morning dose (visit 5).	No
Secondary	Total Number of Reliever Medication Inhalations Per 24h	Change from run-in	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.	No
Secondary	Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)	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.	Daily, during run-in and treatment	No
Secondary	Overall Mean CCQ (Clinical COPD Questionnaire)	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.	Mean over week 0, mean over week 1, mean over week 2, and mean over week 4	No
Secondary	Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD)	The total score is calculated using all questions including their weights and scores range from 0 (perfect health) to 100 (worst possible state)	At baseline (visit 2) and after 4 weeks of treatment (visit 5).	No