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This study is to assess the effects with two different inhaled respiratory medications with regards to improvement of lung function, symptoms and morning activities.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Symbicort Turbuhaler First, then Seretide Diskus | Experimental | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
|
| Seretide Diskus First, then Symbicort Turbuhaler | Experimental | Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Tomas Andersson, MD | AstraZeneca | Study Director |
| Martyn R Partridge, MD FRCP | Faculty of Medicine, Imperial College, NHLI at Charing Cross Hospital, LONDON, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Research Site | Monte Grande | Buenos Aires | Argentina | |||
| Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 19897551 | Derived | 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. |
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706 subjects were enrolled; 264 were not randomised: 190 with eligibility not fulfilled, 11 with adverse events, 4 with discontinuation criteria, 40 voluntary discontinuations, 2 lost to follow-ups, 6 non-compliance, 1 for safety reasons, 10 with other reasons not specified. 442 subjects were randomised
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| ID | Title | Description |
|---|---|---|
| FG000 | Symbicort Turbuhaler First, Then Seretide Diskus | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
| FG001 | Seretide Diskus First, Then Symbicort Turbuhaler |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Period 1 |
|
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| Seretide Diskus (salmeterol/fluticasone) 50/500 μg | Drug |
|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| Quilmes |
| Buenos Aires |
| Argentina |
| Research Site | San Miguel de Tucumán | Tucumán Province | Argentina |
| Research Site | Ciudad Autonoma de Bs. As. | Argentina |
| Research Site | Ciudad de Buenos Aires | Argentina |
| Research Site | Concord | New South Wales | Australia |
| Research Site | Adelaide | South Australia | Australia |
| Research Site | Daw Park | South Australia | Australia |
| Research Site | Woodville South | South Australia | Australia |
| Research Site | Melbourne | Victoria | Australia |
| Research Site | Parkville | Victoria | Australia |
| Research Site | Nedlands | Western Australia | Australia |
| Research Site | Jambes | Belgium | Belgium |
| Research Site | Malmedy | Belgium | Belgium |
| Research Site | Montigny-le-Tilleul | Belgium | Belgium |
| Research Site | Porto Alegre | Brasil | Brazil |
| Research Site | Juiz de Fora | Minas Gerais | Brazil |
| Research Site | Recife | Pernambuco | Brazil |
| Research Site | Rio de Janeiro | Rio de Janeiro | Brazil |
| Research Site | Porto Alegre | Rio Grande do Sul | Brazil |
| Research Site | Florianópolis | Santa Catarina | Brazil |
| Research Site | Santo André | São Paulo | Brazil |
| Research Site | São Paulo | São Paulo | Brazil |
| Research Site | Rio de Janeiro | Brazil |
| Research Site | Aalborg | Denmark |
| Research Site | Hellerup | Denmark |
| Research Site | Hvidovre | Denmark |
| Research Site | København NV | Denmark |
| Research Site | Odense C | Denmark |
| Research Site | Rødovre Municipality | Denmark |
| Research Site | Silkeborg | Denmark |
| Research Site | Berlin | Germany |
| Research Site | Erfurt | Germany |
| Research Site | Leipzig | Germany |
| Research Site | Marburg | Germany |
| Research Site | Hyderabad | Andhra Pradesh | India |
| Research Site | Bangalore | Karnataka | India |
| Research Site | Jaipur | Rajasthan | India |
| Research Site | Coimbatore | India |
| Research Site | Noida | India |
| Research Site | Manila | Philippines |
| Research Site | Quezon City | Philippines |
| Research Site | Dartford | Kent | United Kingdom |
| Research Site | Hamilton | Lanarkshire | United Kingdom |
| Research Site | Motherwell | Lanarkshire | United Kingdom |
| Research Site | Cookstown | Northern Ireland | United Kingdom |
| Research Site | Limavady | Northern Ireland | United Kingdom |
| Research Site | Newtownabbey | Northern Ireland | United Kingdom |
| Research Site | Barry | South Glamorgan | United Kingdom |
| Research Site | Barry | Vale of Glamorgan | United Kingdom |
| Research Site | Bradford-on-Avon | Wiltshire | United Kingdom |
| Research Site | Airdrie | United Kingdom |
| Research Site | Birmingham | United Kingdom |
| Research Site | Blantyre | United Kingdom |
| Research Site | Bolton | United Kingdom |
| Research Site | Carrickfergus | United Kingdom |
| Research Site | Chesterfield | United Kingdom |
| Research Site | Coventry | United Kingdom |
| Research Site | Hamilton | United Kingdom |
Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg
| COMPLETED |
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| NOT COMPLETED |
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| Period 2 |
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| Period 3 |
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| ID | Title | Description |
|---|---|---|
| BG000 | Symbicort Turbuhaler First, Then Seretide Diskus | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg |
| BG001 | Seretide Diskus First, Then Symbicort Turbuhaler | Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age Continuous | Mean | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | liters/minute | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
|
|
| ||||||||||||||||||||||||||||
| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters/minutes | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
|
| |||||||||||||||||||||||||||||
| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters/minute | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
|
| |||||||||||||||||||||||||||||
| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters/minute | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
|
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| 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. | Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
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| 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. | Includes all subjects with at least one dose of study medication and contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
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| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
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| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters/minute | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
|
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| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters/minute | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
|
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| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
|
| |||||||||||||||||||||||||||||
| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
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| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters | Baseline (run-in, and washout) and day 1 of treatment period |
|
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| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Liters | Baseline (run-in, and washout) and day 1 of treatment period |
|
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| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | units on a scale | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
|
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| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
|
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| 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. | Includes all subjects with at least one dose of study medication and who contribute sufficient data for the endpoint to be calculated. | Posted | Mean | Standard Deviation | Units on a scale | Baseline (daily records during run-in, and washout) and daily records during the treatment period of 7 days |
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Symbicort Turbuhaler | Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg | 3 | 420 | 0 | 420 | ||
| EG001 | Seretide Diskus | Seretide Diskus (salmeterol/fluticasone) 50/500 μg | 1 | 429 | 0 | 429 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Gait disturbance | General disorders | MedDRA 11.0 | Systematic Assessment |
| |
| Chronic obstructive oulmonary disease | Respiratory, thoracic and mediastinal disorders | MedDRA 11.0 | Systematic Assessment |
|
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Prior to any publication or disclosure, the PI provides AstraZeneca with preliminary data and drafts and with the proposed final manuscript. AstraZeneca shall have a period of 30 days from receipt of the proposed final manuscript to review it and may within such time frame require that submission for publication or disclosure be delayed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gerard Lynch | AstraZeneca | AZTrial_Results_Posting@astrazeneca.com |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D000069502 | Budesonide, Formoterol Fumarate Drug Combination |
| D019819 | Budesonide |
| D000068759 | Formoterol Fumarate |
| D000068299 | Salmeterol Xinafoate |
| D000068298 | Fluticasone |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D000588 | Amines |
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D004338 | Drug Combinations |
| D004364 | Pharmaceutical Preparations |
| D000420 | Albuterol |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000730 | Androstadienes |
| D000736 | Androstenes |
| D000731 | Androstanes |
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| Discontinuation criteria |
|
| Severe non-compliance |
|
| Other |
|
| Male |
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