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

Purpose

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	Intervention	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
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Crossover Assignment Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

MedlinePlus related topics: COPD (Chronic Obstructive Pulmonary Disease) Methamphetamine

Drug Information available for: Formoterol fumarate Budesonide Formoterol Fluticasone propionate Salmeterol Fluticasone Salmeterol xinafoate Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: Yes ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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.

Enrollment:	442
Study Start Date:	September 2007
Study Completion Date:	August 2008
Primary Completion Date:	August 2008 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Symbicort Turbuhaler First, then Seretide Diskus Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg First, then Seretide Diskus (salmeterol/fluticasone) 50/500 μg	Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg
Experimental: Seretide Diskus First, then Symbicort Turbuhaler Seretide Diskus (salmeterol/fluticasone) 50/500 μg First, then Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg	Drug: Symbicort Turbuhaler (budesonide/formoterol) 320/9 μg Drug: Seretide Diskus (salmeterol/fluticasone) 50/500 μg

Eligibility

Ages Eligible for Study:	40 Years and older
Genders Eligible for Study:	Both
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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00542880

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

More Information

No publications provided by AstraZeneca

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Partridge MR, Miravitlles M, Ståhl 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. Epub 2009 Nov 6.

Responsible Party:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00542880 History of Changes
Other Study ID Numbers:	D5892C00016
Study First Received:	October 10, 2007
Results First Received:	August 4, 2009
Last Updated:	July 27, 2012
Health Authority:	Argentina: Administracion Nacional de Medicamentos, Alimentos y Tecnologia Medica Australia: Department of Health and Ageing Therapeutic Goods Administration Belgium: Ministerie Van Sociale Zaken Brazil: National Health Surveillance Agency Denmark: Danish Medicines Agency Germany: Bundesinstitut für Arzneimittel und Medizin India: Drug Controller General Philippines: Bureau of Food and Drugs United Kingdom: Information Processing Unit - Area 6

Keywords provided by AstraZeneca:

COPD
Symbicort
Seretide

Additional relevant MeSH terms:

Lung Diseases
Respiration Disorders
Pulmonary Disease, Chronic Obstructive
Lung Diseases, Obstructive
Respiratory Tract Diseases
Budesonide
Formoterol
Salmeterol
Fluticasone
Fluticasone, salmeterol drug combination
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs

Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Dermatologic Agents

ClinicalTrials.gov processed this record on May 19, 2013

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