Evaluation of Onset of Effect in Patients With Severe Chronic Obstructive Pulmonary Disease (COPD) Treated With Symbicort® Compared to Seretide® (SPEED)
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| ClinicalTrials.gov Identifier: NCT00542880 |
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Recruitment Status :
Completed
First Posted : October 12, 2007
Results First Posted : August 30, 2012
Last Update Posted : August 30, 2012
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Sponsor:
AstraZeneca
Information provided by (Responsible Party):
AstraZeneca
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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.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Chronic Obstructive Pulmonary Disease (COPD) | Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 442 participants |
| Allocation: | Randomized |
| Intervention Model: | Crossover Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 Start Date : | September 2007 |
| Actual Primary Completion Date : | August 2008 |
| Actual Study Completion Date : | August 2008 |
Resource links provided by the National Library of Medicine
| Arm | Intervention/treatment |
|---|---|
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Experimental: Symbicort Turbuhaler First, then Seretide Diskus
Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg
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Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
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Experimental: Seretide Diskus First, then Symbicort Turbuhaler
Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
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Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
Primary Outcome Measures :
- Peak Expiratory Flow (PEF) 5 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
Secondary Outcome Measures :
- PEF Before Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- PEF 15 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- PEF Before Evening Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- Forced Expiratory Volume in 1 Second (FEV1) Before Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- FEV1 15 Minutes After Morning Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- FEV1 Before Evening Dose [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- Change in PEF From Before Dose to 5 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- Change in PEF From Before Dose to 15 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- Change in FEV1from Before Dose to 5 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- Change in FEV1 From Before Dose to 15 Minutes After Dose in the Morning [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- Change in FEV1 From Before Dose to 5 Minutes After Dose at the Clinic [ Time Frame: Baseline (run-in, and washout) and day 1 of treatment period ]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.
- Change in Forced Vital Capacity (FVC) From Before Dose to5 Minutes After Dose at the Clinic [ Time Frame: Baseline (run-in, and washout) and day 1 of treatment period ]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.
- Capacity of Daily Living in the Morning (CDLM) (Change From Pre to End of Treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- Difficulty in Getting Out From Bed (MASQ) (Change From Pre to End of Treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
- The Clinical Chronic Obstructive Pulmonary Disease (COPD) Questionnaire (Change From Pre to End of Treatment) [ Time Frame: Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days ]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.
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| Ages Eligible for Study: | 40 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00542880
Locations
Show 60 study locations
Sponsors and Collaborators
AstraZeneca
Investigators
| Study Director: | Tomas Andersson, MD | AstraZeneca | |
| Principal Investigator: | Martyn R Partridge, MD FRCP | Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | AstraZeneca |
| ClinicalTrials.gov Identifier: | NCT00542880 |
| Other Study ID Numbers: |
D5892C00016 |
| First Posted: | October 12, 2007 Key Record Dates |
| Results First Posted: | August 30, 2012 |
| Last Update Posted: | August 30, 2012 |
| Last Verified: | July 2012 |
Keywords provided by AstraZeneca:
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COPD Symbicort Seretide |
Additional relevant MeSH terms:
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Lung Diseases Lung Diseases, Obstructive Pulmonary Disease, Chronic Obstructive Respiratory Tract Diseases Fluticasone Budesonide Formoterol Fumarate Salmeterol Xinafoate Fluticasone-Salmeterol Drug Combination Budesonide, Formoterol Fumarate Drug Combination Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs |
Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Sympathomimetics |