Clinical trial NCT00929708: Efficacy of AZD3199 in Chronic Obstructive Pulmonary Disease (COPD) Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: COPD
Keywords: COPD
Efficacy
Safety
Inhalation
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-06-29
Enrollment: 329
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* COPD
* Current or exsmokers, 10 pack years

Exclusion Criteria:

* Asthma
* Any clinically relevant abnormal findings at screening examinations
* Recent COPD exacerbation

Primary outcomes:
measure: FEV1, E0-4; the Average Value at Visit 5 From Before to 4 Hours After Morning Dose (Peak Effect)
timeFrame: 0,5 min, 15 min, 60 min, 2 h, 4 h
measure: FEV1, E24-26; the Average Value at Visit 5 Between 24 and 26 Hours Following the Morning Dose (Trough Effect)
timeFrame: 24h, 26h
Secondary outcomes:
measure: Cmax; the Highest Plasma Concentration of AZD3199 Measured
timeFrame: 0,15 min, 1, 4 and 24 hours post dose
measure: AUC0-24; Area Under the Plasma Concentration Curve From Zero to 24 Hours After Dose
timeFrame: 0,15 min, 1, 4 and 24 hours post dose
measure: FEV1 Post Salbutamol Inhalation
timeFrame: Baseline (visit 2) and 26 h after the last morning dose (visit 5).
measure: Total Number of Reliever Medication Inhalations Per 24h
timeFrame: 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.
measure: Total AstraZeneca COPD Symptoms Scores (Included Breathlessness, Chest Tightness, Cough and Night-time Awakenings)
timeFrame: Daily, during run-in and treatment
measure: Overall Mean CCQ (Clinical COPD Questionnaire)
timeFrame: Mean over week 0, mean over week 1, mean over week 2, and mean over week 4
measure: Total Score SGRQ-C (St George's Respiratory Questionnaire for COPD)
timeFrame: At baseline (visit 2) and after 4 weeks of treatment (visit 5).
Other outcomes:
Locations:
city: Blagoevgrad
country: Bulgaria
facility: Research Site
city: Pleven
country: Bulgaria
facility: Research Site
city: Russe
country: Bulgaria
facility: Research Site
city: Sofia
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Moncton
country: Canada
facility: Research Site
state: New Brunswick
city: St. John's
country: Canada
facility: Research Site
state: Newfoundland and Labrador
city: Truro
country: Canada
facility: Research Site
state: Nova Scotia
city: Mississauga
country: Canada
facility: Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Research Site
state: Ontario
city: Toronto
country: Canada
facility: Research Site
state: Ontario
city: Pointe-claire
country: Canada
facility: Research Site
state: Quebec
city: Saint-romuald
country: Canada
facility: Research Site
state: Quebec
city: Trois Rivieres
country: Canada
facility: Research Site
state: Quebec
city: Yanagawa
country: Japan
facility: Research Site
state: Fukuoka
city: Fukuyama
country: Japan
facility: Research Site
state: Hiroshima
city: Chitose
country: Japan
facility: Research Site
state: Hokkaido
city: Obihiro
country: Japan
facility: Research Site
state: Hokkaido
city: Tomakomai
country: Japan
facility: Research Site
state: Hokkaido
city: Hitachi
country: Japan
facility: Research Site
state: Ibaragi
city: Naka-gun
country: Japan
facility: Research Site
state: Ibaraki
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Toyonaka
country: Japan
facility: Research Site
state: Osaka
city: Moriyama
country: Japan
facility: Research Site
state: Shiga
city: Otsu
country: Japan
facility: Research Site
state: Shiga
city: Machida
country: Japan
facility: Research Site
state: Tokyo
city: Kitakyusyu
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: BIAlYSTOK
country: Poland
facility: Research Site
city: Gorzow Wlkp
country: Poland
facility: Research Site
city: Lodz
country: Poland
facility: Research Site
city: Lublin
country: Poland
facility: Research Site
city: POZNAn
country: Poland
facility: Research Site
city: Szczecin
country: Poland
facility: Research Site
city: Tarnow
country: Poland
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: Novosibirsk
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
Study officials:
affiliation: University Hospital, Lodz, Poland
name: Piotr Kuna, Professor
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.