Chronic Obstructive Pulmonary Disease (COPD) Clinical Trial
— SPEEDOfficial 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.
This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.
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 |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment
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 |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Argentina, Australia, Belgium, Brazil, Denmark, Germany, India, Philippines, United Kingdom,
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 |
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