Clinical trial NCT00628862: Evaluation of Efficacy and Safety of Formoterol in Patients With COPD Compared With Placebo in Patients in Japan, EU
Official title: A 12-week, Randomised, Double-blind, Placebo-controlled, Parallel-group, Multi-national, Phase III, Efficacy and Safety Study of Inhaled Formoterol 4.5 μg and 9 μg Twice Daily in Japanese and European Patients With Chronic Obstructive Pulmonary Disease (COPD)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Obstructive Pulmonary Disease
Keywords: Chronic Obstructive Pulmonary Disease
COPD
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2008-03-05
Enrollment: 613
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 show the efficacy and safety of formoterol for the maintenance treatment of patients with COPD compared with placebo in patients in Japan and in European countries during 12 weeks.


Eligibility criteria: Inclusion Criteria:

* Males or females aged above 40 with a clinical diagnosis of COPD and current COPD symptoms
* Current or previous smoker with a smoking history of 10 or more pack years
* Lung function parameters: FEV1/FVC \< 70%, post-bronchodilator and post-bronchodilator FEV1 \< 80% of predicted normal value

Exclusion Criteria:

* History and/or current clinical diagnosis of asthma or atopic diseases such as allergic rhinitis
* Use of inhaled glucocorticosteroids within 4 weeks prior to Visit 2
* Any relevant cardiovascular disorder as judged by the investigator or any current respiratory tract disorder other than COPD.

Primary outcomes:
measure: Forced Expiratory Volume in 1 Second (FEV1; L) 60 Minutes Post-dose
timeFrame: from baseline up to 12 weeks
Secondary outcomes:
measure: Forced Vital Capacity (FVC) 60 Minutes Post-dose
timeFrame: from baseline up to 12 weeks
measure: FEV1 Pre-dose
timeFrame: baseline at week 0 and pre-dose at weeks 4, 8 and 12
measure: FVC Pre-dose
timeFrame: baseline at week 0 and pre-dose at weeks 4, 8 and 12
measure: FEV1 5 Minutes Post-dose
timeFrame: baseline and 5 minutes anter first dose
measure: FVC 5 Minutes Post-dose
timeFrame: baseline and 5 minutes anter first dose
measure: Change in Peak Expiratory Flow (PEF), Morning
timeFrame: run-in period and 12 week
measure: Change in Peak Expiratory Flow (PEF), Evening
timeFrame: run-in period and 12 week
measure: Change in Night-time Awakenings Due to Symptoms
timeFrame: run-in period up to 12 weeks
measure: Breathlessness
timeFrame: run-in period up to 12 weeks
measure: Cough
timeFrame: run-in period up to 12 weeks
measure: Use of Reliever Medication
timeFrame: 12 weeks (end of run-in to last visit)
measure: St George's Respiratory Questionnaire (SGRQ)
timeFrame: 12 weeks (end of run-in to last visit)
Other outcomes:
Locations:
city: Gabrovo
country: Bulgaria
facility: Research Site
city: Lovech
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: Stara Zagora
country: Bulgaria
facility: Research Site
city: Troyan
country: Bulgaria
facility: Research Site
city: Varna
country: Bulgaria
facility: Research Site
city: Nagoya
country: Japan
facility: Research Site
state: Aichi
city: Seto
country: Japan
facility: Research Site
state: Aichi
city: Noda
country: Japan
facility: Research Site
state: Chiba
city: Touon
country: Japan
facility: Research Site
state: Ehime
city: Yanagawa
country: Japan
facility: Research Site
state: Fukuoka
city: ORA
country: Japan
facility: Research Site
state: Gunma
city: OTA
country: Japan
facility: Research Site
state: Gunma
city: Asahikawa
country: Japan
facility: Research Site
state: Hokkaido
city: Chitose
country: Japan
facility: Research Site
state: Hokkaido
city: Obihiro
country: Japan
facility: Research Site
state: Hokkaido
city: Sapporo
country: Japan
facility: Research Site
state: Hokkaido
city: Tomakomai
country: Japan
facility: Research Site
state: Hokkaido
city: Yabu
country: Japan
facility: Research Site
state: Hyogo
city: Naka-gun
country: Japan
facility: Research Site
state: Ibaraki
city: Morioka
country: Japan
facility: Research Site
state: Iwate
city: Kawasaki
country: Japan
facility: Research Site
state: Kangawa
city: Sendai
country: Japan
facility: Research Site
state: Miyagi
city: Katano
country: Japan
facility: Research Site
state: Osaka
city: Kishiwada
country: Japan
facility: Research Site
state: Osaka
city: Takatsuiki
country: Japan
facility: Research Site
state: Osaka
city: Chiyoda
country: Japan
facility: Research Site
state: Tokyo
city: UBE
country: Japan
facility: Research Site
state: Yamaguchi
city: Hiroshima
country: Japan
facility: Research Site
city: Kagoshima
country: Japan
facility: Research Site
city: Kochi
country: Japan
facility: Research Site
city: Kyoto
country: Japan
facility: Research Site
city: Osaka
country: Japan
facility: Research Site
city: Wakayama
country: Japan
facility: Research Site
city: Deva
country: Romania
facility: Research Site
state: Hunedoara
city: Bucharest
country: Romania
facility: Research Site
city: Bucuresti
country: Romania
facility: Research Site
city: Constanta
country: Romania
facility: Research Site
city: Iasi
country: Romania
facility: Research Site
city: Kazan
country: Russian Federation
facility: Research Site
city: Moscow
country: Russian Federation
facility: Research Site
city: St. Petersburg
country: Russian Federation
facility: Research Site
city: Dnipropetrovsk
country: Ukraine
facility: Research Site
city: Donetsk
country: Ukraine
facility: Research Site
city: Kharkiv
country: Ukraine
facility: Research Site
city: Kyiv
country: Ukraine
facility: Research Site
Study officials:
affiliation: AstraZeneca R&D Lund, Sweden
name: Lars-Goran Carlsson, MD
role: STUDY_DIRECTOR
affiliation: Clinica Medic Or, Calea
name: Miron A Bogdan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Bogdan MA, Aizawa H, Fukuchi Y, Mishima M, Nishimura M, Ichinose M. Efficacy and safety of inhaled formoterol 4.5 and 9 mug twice daily in Japanese and European COPD patients: phase III study results. BMC Pulm Med. 2011 Nov 15;11:51. doi: 10.1186/1471-2466-11-51.