Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide®

Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial

— SPEED  

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00542880
• Other study ID #: D5892C00016
• Status: Completed
• Phase: Phase 4
• First received: October 10, 2007
• Last updated: July 27, 2012
• Start date: September 2007
• Est. completion date: August 2008

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia MedicaAustralia: Department of Health and Ageing Therapeutic Goods AdministrationBelgium: Ministerie Van Sociale ZakenBrazil: National Health Surveillance AgencyDenmark: Danish Medicines AgencyGermany: Bundesinstitut für Arzneimittel und MedizinIndia: Drug Controller GeneralPhilippines: Bureau of Food and DrugsUnited Kingdom: Information Processing Unit - Area 6
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 442
• Est. completion date: August 2008
• Est. primary completion date: August 2008
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years and older

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease (COPD)
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Symbicort Turbuhaler (budesonide/formoterol) 320/9 µg

• Seretide Diskus (salmeterol/fluticasone) 50/500 µg

Locations

Country	Name	City	State
Argentina	Research Site	Ciudad Autonoma de Bs. As.
Argentina	Research Site	Ciudad de Buenos Aires
Argentina	Research Site	Monte Grande	Buenos Aires
Argentina	Research Site	Quilmes	Buenos Aires
Argentina	Research Site	San Miguel de Tucuman	Tucuman
Australia	Research Site	Adelaide	South Australia
Australia	Research Site	Concord	New South Wales
Australia	Research Site	Daw Park	South Australia
Australia	Research Site	Melbourne	Victoria
Australia	Research Site	Nedlands	Western Australia
Australia	Research Site	Parkville	Victoria
Australia	Research Site	Woodville South	South Australia
Belgium	Research Site	Jambes
Belgium	Research Site	Malmedy
Belgium	Research Site	Montigny-le-tilleul
Brazil	Research Site	Florianopolis	Santa Catarina
Brazil	Research Site	Juiz de Fora	MG
Brazil	Research Site	Porto Alegre	Brasil
Brazil	Research Site	Porto Alegre	RS
Brazil	Research Site	Recife	PE
Brazil	Research Site	Rio de Janeiro	RJ
Brazil	Research Site	Rio de Janeiro
Brazil	Research Site	Santo Andre	SP
Brazil	Research Site	Sao Paulo	SP
Denmark	Research Site	Aalborg
Denmark	Research Site	Alborg
Denmark	Research Site	Hellerup
Denmark	Research Site	Hvidovre
Denmark	Research Site	Kobenhavn Nv
Denmark	Research Site	Odense C
Denmark	Research Site	Rodovre
Denmark	Research Site	Silkeborg
Germany	Research Site	Berlin
Germany	Research Site	Erfurt
Germany	Research Site	Leipzig
Germany	Research Site	Marburg
India	Research Site	Bangalore	Karnataka
India	Research Site	Coimbatore
India	Research Site	Hyderabad	Andhra Pradesh
India	Research Site	Jaipur	Rajasthan
India	Research Site	Noida
Philippines	Research Site	Manila
Philippines	Research Site	Quezon City
United Kingdom	Research Site	Airdrie
United Kingdom	Research Site	Barry	South Glamorgan
United Kingdom	Research Site	Barry	Vale of Glamorgan
United Kingdom	Research Site	Birmingham
United Kingdom	Research Site	Blantyre
United Kingdom	Research Site	Bolton
United Kingdom	Research Site	Bradford-on-avon	Wiltshire
United Kingdom	Research Site	Carrickfergus
United Kingdom	Research Site	Chesterfield
United Kingdom	Research Site	Cookstown	N. Ireland
United Kingdom	Research Site	Coventry
United Kingdom	Research Site	Dartford	Kent
United Kingdom	Research Site	Hamilton	Lanarkshire
United Kingdom	Research Site	Hamilton
United Kingdom	Research Site	Limavady	Northern Ireland
United Kingdom	Research Site	Motherwell	Lanarkshire
United Kingdom	Research Site	Newtownabbey	Northern Ireland

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Argentina,  Australia,  Belgium,  Brazil,  Denmark,  Germany,  India,  Philippines,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose	The change from baseline in PEF was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and all days of treatment, with baseline as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	PEF Before Morning Dose	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	PEF 15 Minutes After Morning Dose	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	PEF Before Evening Dose	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	FEV1 15 Minutes After Morning Dose	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	FEV1 Before Evening Dose	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	Change in PEF From Before Dose to 5 Minutes After Dose in the Morning	The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with pre-dose run-in/washout as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	Change in PEF From Before Dose to 15 Minutes After Dose in the Morning	The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning	The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning	The change from pre-dose was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with mean pre-dose run-in/washout as covariate.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic	The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.	Baseline (run-in, and washout) and day 1 of treatment period	No
Secondary	Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic	The change from pre-dose was calculated using the pre-dose baseline value (run-in and washout period respectively), and pre-dose value at day 1, with pre-dose run-in/washout as covariate.	Baseline (run-in, and washout) and day 1 of treatment period	No
Secondary	Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment)	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	Yes
Secondary	Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment)	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 5 with 0=worst and 5 = best.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No
Secondary	The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment)	The change from baseline was calculated using the average over baseline (the last 7 days of run-in and washout period respectively), and over all days of treatment, with baseline as covariate. Score scale 0 - 6 with 0=worst and 6 = best.	Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days	No