Clinical trial NCT00542880: Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®
Official title: A Double-blind, Randomised, Cross-over, Multi-centre Study, to Evaluate Onset of Effect in the Morning in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort®Turbuhaler® 320/9 μg, Compared With Seretide® Diskus® 50/500 μg, Both Given as One Inhalation Twice Daily for One Week Each.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Obstructive Pulmonary Disease (COPD)
Keywords: COPD
Symbicort
Seretide
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2007-10-12
Enrollment: 442
Sex: ALL
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.


Eligibility criteria: Inclusion Criteria:

* Outpatient, female or male aged ≥40 years, diagnosis of COPD with symptoms for at least 2 years
* FEV1 ≤50% of predicted normal value, pre-bronchodilator, FEV1/VC \<70%
* Pre-bronchodilator

Exclusion Criteria:

* Current respiratory tract disorder other than COPD
* History of asthma or rhinitis
* Significant or unstable cardiovascular disorder

Primary outcomes:
measure: Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Secondary outcomes:
measure: PEF Before Morning Dose
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: PEF 15 Minutes After Morning Dose
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: PEF Before Evening Dose
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: FEV1 15 Minutes After Morning Dose
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: FEV1 Before Evening Dose
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: Change in PEF From Before Dose to 5 Minutes After Dose in the Morning
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: Change in PEF From Before Dose to 15 Minutes After Dose in the Morning
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic
timeFrame: Baseline (run-in, and washout) and day 1 of treatment period
measure: Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic
timeFrame: Baseline (run-in, and washout) and day 1 of treatment period
measure: Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
measure: The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)
timeFrame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days
Other outcomes:
Locations:
city: Monte Grande
country: Argentina
facility: Research Site
state: Buenos Aires
city: Quilmes
country: Argentina
facility: Research Site
state: Buenos Aires
city: San Miguel de Tucuman
country: Argentina
facility: Research Site
state: Tucuman
city: Ciudad Autonoma de Bs. As.
country: Argentina
facility: Research Site
city: Ciudad de Buenos Aires
country: Argentina
facility: Research Site
city: Concord
country: Australia
facility: Research Site
state: New South Wales
city: Adelaide
country: Australia
facility: Research Site
state: South Australia
city: Daw Park
country: Australia
facility: Research Site
state: South Australia
city: Woodville South
country: Australia
facility: Research Site
state: South Australia
city: Melbourne
country: Australia
facility: Research Site
state: Victoria
city: Parkville
country: Australia
facility: Research Site
state: Victoria
city: Nedlands
country: Australia
facility: Research Site
state: Western Australia
city: Jambes
country: Belgium
facility: Research Site
city: Malmedy
country: Belgium
facility: Research Site
city: Montigny-le-tilleul
country: Belgium
facility: Research Site
city: Porto Alegre
country: Brazil
facility: Research Site
state: Brasil
city: Juiz de Fora
country: Brazil
facility: Research Site
state: MG
city: Recife
country: Brazil
facility: Research Site
state: PE
city: Rio de Janeiro
country: Brazil
facility: Research Site
state: RJ
city: Porto Alegre
country: Brazil
facility: Research Site
state: RS
city: Florianopolis
country: Brazil
facility: Research Site
state: Santa Catarina
city: Santo Andre
country: Brazil
facility: Research Site
state: SP
city: Sao Paulo
country: Brazil
facility: Research Site
state: SP
city: Rio de Janeiro
country: Brazil
facility: Research Site
city: Aalborg
country: Denmark
facility: Research Site
city: Alborg
country: Denmark
facility: Research Site
city: Hellerup
country: Denmark
facility: Research Site
city: Hvidovre
country: Denmark
facility: Research Site
city: Kobenhavn Nv
country: Denmark
facility: Research Site
city: Odense C
country: Denmark
facility: Research Site
city: Rodovre
country: Denmark
facility: Research Site
city: Silkeborg
country: Denmark
facility: Research Site
city: Berlin
country: Germany
facility: Research Site
city: Erfurt
country: Germany
facility: Research Site
city: Leipzig
country: Germany
facility: Research Site
city: Marburg
country: Germany
facility: Research Site
city: Hyderabad
country: India
facility: Research Site
state: Andhra Pradesh
city: Bangalore
country: India
facility: Research Site
state: Karnataka
city: Jaipur
country: India
facility: Research Site
state: Rajasthan
city: Coimbatore
country: India
facility: Research Site
city: Noida
country: India
facility: Research Site
city: Manila
country: Philippines
facility: Research Site
city: Quezon City
country: Philippines
facility: Research Site
city: Dartford
country: United Kingdom
facility: Research Site
state: Kent
city: Hamilton
country: United Kingdom
facility: Research Site
state: Lanarkshire
city: Motherwell
country: United Kingdom
facility: Research Site
state: Lanarkshire
city: Cookstown
country: United Kingdom
facility: Research Site
state: N. Ireland
city: Limavady
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Newtownabbey
country: United Kingdom
facility: Research Site
state: Northern Ireland
city: Barry
country: United Kingdom
facility: Research Site
state: South Glamorgan
city: Barry
country: United Kingdom
facility: Research Site
state: Vale of Glamorgan
city: Bradford-on-avon
country: United Kingdom
facility: Research Site
state: Wiltshire
city: Airdrie
country: United Kingdom
facility: Research Site
city: Birmingham
country: United Kingdom
facility: Research Site
city: Blantyre
country: United Kingdom
facility: Research Site
city: Bolton
country: United Kingdom
facility: Research Site
city: Carrickfergus
country: United Kingdom
facility: Research Site
city: Chesterfield
country: United Kingdom
facility: Research Site
city: Coventry
country: United Kingdom
facility: Research Site
city: Hamilton
country: United Kingdom
facility: Research Site
Study officials:
affiliation: AstraZeneca
name: Tomas Andersson, MD
role: STUDY_DIRECTOR
affiliation: Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK
name: Martyn R Partridge, MD FRCP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Partridge MR, Miravitlles M, Stahl E, Karlsson N, Svensson K, Welte T. Development and validation of the Capacity of Daily Living during the Morning questionnaire and the Global Chest Symptoms Questionnaire in COPD. Eur Respir J. 2010 Jul;36(1):96-104. doi: 10.1183/09031936.00123709. Epub 2009 Nov 6.