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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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EUCTR |
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Last refreshed on:
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4 January 2022 |
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Main ID: |
EUCTR2007-001337-34-BE |
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Date of registration:
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08/10/2007 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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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 budesonide/formoterol (Symbicort®Turbuhaler®) 320/9 µg, compared with salmeterol/fluticasone (Seretide® Diskus®) 50/500 µg, both given as one inhalation twice daily for one week each. - SPEED
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Scientific title:
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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 budesonide/formoterol (Symbicort®Turbuhaler®) 320/9 µg, compared with salmeterol/fluticasone (Seretide® Diskus®) 50/500 µg, both given as one inhalation twice daily for one week each. - SPEED |
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Date of first enrolment:
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25/10/2007 |
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Target sample size:
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420 |
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Recruitment status: |
Not Recruiting |
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URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2007-001337-34 |
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Study type:
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Interventional clinical trial of medicinal product |
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Study design:
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Controlled: yes
Randomised: yes
Open: no
Single blind: no
Double blind: yes
Parallel group: no
Cross over: yes
Other: yes
Other trial design description: Double dummy technique for blinding
If controlled, specify comparator, Other Medicinial Product: yes
Placebo: yes
Other: no
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): no
Therapeutic use (Phase IV): yes
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Countries of recruitment
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Belgium
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Denmark
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Germany
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United Kingdom
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Contacts
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Key inclusion & exclusion criteria
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Inclusion criteria:
For inclusion in the study patients must fulfil all of the following criteria:
1. Provision of informed consent prior to conducting any study-related procedures.
2. Outpatient, female or male aged =40 years.
3. A clinical diagnosis of COPD with symptoms for more than 2 years, prior to visit 2.
4. A current or previous smoker with a smoking history =10 pack years (1 pack year
= 20 cigarettes smoked per day for one year).
5. FEV1 =50% of predicted normal value, pre-bronchodilator.
6. FEV1/VC <70%, pre-bronchodilator.
7. Previous use of a short-acting inhaled bronchodilator (ß2-agonist or anticholinergics) as reliever medication.
8. A history of at least one COPD exacerbation requiring a course of oral steroids and/or antibiotics within 1 to 12 months prior to visit 2.
9. Able to read and write and use the electronic devices (eDiary and ePEF).
To be randomised the patient must fulfil the following criteria at Visit 3:
10. Total morning symptoms score of at least 2 (GCSQ score) on 5 out of the last 7 days of the run-in period, excluding day of visit 3.
11. Complete morning records of PEF data on at least 5 out of the last 7 days of the run-in period, excluding day of visit 3.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range
Exclusion criteria:
Any of the following is regarded as a criterion for exclusion from the study:
1. A history of asthma.
2. A history of seasonal allergic rhinitis before 40 years of age.
3. Significant or unstable ischaemic heart disease, arrhythmia, cardiomyopathy, heart
failure, uncontrolled hypertension as defined by the investigator, or any other relevant cardiovascular disorder, as judged by the investigator.
4. Any current respiratory tract disorder other than COPD, which is considered by the investigator to be clinically significant.
5. Any significant disease or disorder which, in the opinion of the investigator, may either put the patient at risk because of participation in the study, or may influence the results of the study, or the patients ability to participate in the study.
6. Patients taking oral or ophthalmic non-cardioselective ß-blocking agents.
7. Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
8. Regular oxygen therapy.
9. Known or suspected hypersensitivity to study therapy or excipients of the investigational products.
10. Scheduled in-patient hospitalization during the course of the study.
11. Patients who have participated in a clinical study evaluating an investigational
drug in the last 4 weeks (3 months in the UK) prior to visit 2, or who have been previously allocated a randomisation code in this study.
12. Patients with a history of chronic alcohol or drug abuse or any condition associated with poor compliance.
13. Patient participating in or scheduled for an intensive COPD rehabilitation
programme during the course of the study.
14. Any clinically relevant abnormal findings in clinical, physical examination, and vital signs at Visit 2, which in the opinion of the investigator(s) may put the patient at risk because of his/her participation in the study (to be checked before allocation of randomisation code at Visit 3).
15. Exacerbation of COPD during run-in or within 4 weeks prior to visit 2 (from end of
exacerbation), requiring hospitalisation, a course of oral and/or increased doses of inhaled steroids and/or antibiotics.
16. Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the study site)
17. Use of oral/parenteral glucocorticosteroids within 4 weeks prior to Visit 2.
Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes
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Health Condition(s) or Problem(s) studied
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Severe Chronic Obstructive Pulmonary Disease (COPD)
MedDRA version: 9.1
Level: LLT
Classification code 10010952
Term: COPD
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Intervention(s)
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Trade Name: Symbicort forte Turbohaler 320/9 µg/dose
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BUDESONIDE
CAS Number: 51333223
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 320-
INN or Proposed INN: FORMOTEROL FUMARATE
CAS Number: 43229807
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 9-
Pharmaceutical form of the placebo: Inhalation powder
Route of administration of the placebo: Inhalation use
Trade Name: Seretide Diskus 50/500 microgrammes/dose
Pharmaceutical Form: Inhalation powder, pre-dispensed
INN or Proposed INN: SALMETEROL
CAS Number: 89365504
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 50-
INN or Proposed INN: FLUTICASONE PROPIONATE
CAS Number: 80474142
Concentration unit: µg microgram(s)
Concentration type: equal
Concentration number: 500-
Pharmaceutical form of the placebo: Inhalation powder, pre-dispensed
Route of administration of the placebo: Inhalation use
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Primary Outcome(s)
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Secondary Objective: The secondary objective is to evaluate safety by assessing the nature and incidence of adverse events (AEs).
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Main Objective: The primary objective is to evaluate early morning efficacy of Symbicort Turbuhaler
320/9 µg one inhalation twice daily compared to Seretide Diskus 50/500 µg one inhalation twice daily in patients with severe COPD over one week treatment.
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Primary end point(s): The primary efficacy variable will be Peak Expiratory Flow (PEF) 5 minutes after morning dose.
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Secondary ID(s)
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2007-001337-34-GB
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Not Applicable
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D5892C00016
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Source(s) of Monetary Support
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Ethics review
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Status: Approved
Approval date: 25/10/2007
Contact:
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