A comparison of Symbicort Single inhaler Therapy (Symbicort Turbuhaler 160/4.5 mg, 1 inhalation b.i.d. plus as needed) and conventional best practice for the treatment of persistent asthma in adolescents and adults - a 26-week, randomised, open-label, parallel-group, multicentre study - STYLE

• Conditions: This is a Phase IIIB trial to be conducted in patients with persistent asthma; MedDRA version: 7.0Level: LLTClassification code 10003553

• Registration Number: EUCTR2005-000532-25-IS
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-05-12
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

For inclusion in the study patients must fulfil all of the following criteria at Visit 1:
1.Signed informed consent form. For underage patients, informed consent from both patient and the patient’s parent/legal guardian must be obtained.
2.Female or male outpatients aged 12 years and older*.
3.Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (9).
4.Ability to read and write in the local language.
5.Prescribed inhaled GCS at a dose of 320 µg or more per day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
6.Either
- daily maintenance treatment with both inhaled GCS and long-acting Beta2-agonist (LABA)
or
- daily treatment with inhaled GCS alone (i.e. without LABA) and a history of suboptimal asthma control the month prior to enrolment as judged by the investigator
and use of 3 or more inhalations of as needed medication for symptom relief during the last 7 days before enrolment.

* In some countries aged 18 years and older.

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.Previous treatment with Symbicort Single inhaler Therapy (use of Symbicort Turbuhaler for both maintenance treatment and as needed).
2.Use of any Beta-blocking agent, including eye-drops.
3.Use of oral GCS as maintenance treatment for any indication.
4.Known or suspected hypersensitivity to study therapy or excipients.
5.A history of smoking 10 or more pack years (1 pack year = 1 pack (20 cigarettes) per day for one year or equivalent).
6.Pregnancy, breast-feeding or planned pregnancy during the study. Fertile women not using acceptable contraceptive measures, as judged by the investigator.
7.Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study.
8.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 patient at risk because of his/her participation in the study.
9.Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
10.Planned in-patient hospitalisation during the course of the study.
11.Suspected poor capability to follow instructions of the study, e.g. because of a history of drug abuse, difficulty in reading and/or understand instructions or any other reason, as judged by the investigator.
12.Previous allocation of randomisation code in this study.
13.Participating in another clinical trial during the course of this study or within 30 days prior to Visit 1.
14.Involvement in the planning or conduct of this study.

Study & Design

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