Real life effectiveness in asthma of Symbicort® Single Inhaler Therapy (RELEASE) - RELEASE

Phase 1

• Conditions: Classification code 10003553; This is a Phase IIIb Trial to be conducted in adult, uncontrolled asthmatic patients.

• Registration Number: EUCTR2005-000372-41-GB
• Lead Sponsor: AstraZeneca UK Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-04-05
• Study Completion: 2008-10-15
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

For inclusion in the study run-in period Subjects must fulfil the following criteria:
1.Provision of written informed consent.
2.Female or male aged at least 18 years.
3.Confirmed diagnosis of asthma (minimum of 6 months documented history prior to visit 1).
4.Currently receiving a daily dose of 200 to 1000 µg of BDP or 100 to 500 µg of fluticasone or 200 to 800 µg of budesonide or equivalent for at least 4 weeks.
5.Subjects, identified by the investigator, or during routine asthma management, requiring review of their current asthma treatment.
6.The Subject needs to be able to read and to be fluent in English.

For inclusion in the study treatment period Subjects must fulfil the following criteria:
7.At least 1 positive answer on the RCP-3 questionnaire at visit 2.
8.No asthma exacerbations during the run-in period (see section 3.3.5.1 for definition of an asthma exacerbation).
9.No changes deemed necessary in existing asthma medication during the run-in period.

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

1.Documented history of Chronic Obstructive Pulmonary Disease.
2.PEF < 50% of predicted normal value.
3.Any non-asthma related, clinically significant abnormal finding in physical examination and/or vital signs at visit 1, which in the opinion of the Investigator, may put the Subject at risk because of his/her participation in the study.
4.Use of oral, rectal or parenteral glucocorticosteroids (GCS) 30 days prior to visit 1.
5.Women who are pregnant, breast-feeding or planning a pregnancy during the study. Women must be post-menopausal (at least 1 year must have passed after the last menstruation), surgically sterile or using acceptable contraceptives, as judged by the Investigator.
6.Any respiratory tract infection affecting the asthma within 30 days prior to visit 1, as judged by the Investigator.
7.Current use of any ß-blocker therapy (including eye drops).
8.Any significant disease or disorder (e.g. cardiovascular, pulmonary {other than asthma}, gastrointestinal, liver, renal, neurological, musculoskeletal, endocrine, metabolic, malignant, psychiatric, major physical impairment) which, in the opinion of the Investigator, may either put the Subject at risk because of participation in the study, or may influence the results of the study, or the Subject’s ability to participate in the study.
9.Planned in-patient hospitalisation during the course of the study.
10.Subjects not considered capable, as judged by the Investigator, of following the instructions of the study, e.g. because of a history of alcohol or drug abuse or any other reason.
11.Previous enrolment or randomisation of treatment in the present study.
12.Subjects who have participated in another clinical study within 90 days of visit 1.
13.Known or suspected hypersensitivity to active ingredients of study medication or excipients.
14.Involvement in the planning and conduct of the study (applies to both AstraZeneca staff or staff at the investigational site).
15. Smoking, current or previous with a smoking history of more than 10 pack years (one pack year = 1 pack (20 cigarettes) per day for 1 year or equivalent)

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to compare Symbicort® (budesonide 160 µg/inhalation and formoterol fumarate dihydrate 4.5 µg /inhalation) as Single Inhaler Therapy, with a Subject’s previous therapy (including low dose inhaled corticosteroids), by assessment of the changes in the Asthma Control Questionnaire (ACQ) in uncontrolled asthmatic Subjects.;Secondary Objective: Not applicable.;Primary end point(s): The primary outcome variable is the change in ACQ score from baseline (visit 2) to the average value of available data for visits 3-5. In addition, the change in ACQ score from baseline (visit 2) to 4 weeks (visit 3) will be analysed to assess whether Symbicort® Single Inhaler Therapy provides an early onset of action.