A comparison of the efficacy of Symbicort Single inhaler Therapy (Symbicort Turbuhaler 160/4.5 microg, one inhalation twice a day plus as-needed) and conventional best standard treatment for the treatment of persistent asthma in adolescents and adults. A randomised, open, parallel-group, multicentre, 26 weeks study - MONO

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

• Registration Number: EUCTR2004-000679-32-FI
• Lead Sponsor: AstraZeneca Oy

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-11-16
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 1900

Inclusion Criteria

1. Provision of oral and written informed consent. For underage patients, informed consent from both patient and the patient’s parent/legal guardian must be obtained. If the patient cannot read and write, verbal consent from the patient is required.
2. Female or male outpatients aged over 12 years of age
3. Minimum of 3 months history of asthma, diagnosed according to the American Thoracic Society (ATS) definition
4. Prescribed inhaled GCS at a dose of over 320 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
5. a) daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA)(free or fixed combination) or
b) daily treatment with inhaled GCS alone (i.e. without LABA)

and a history of suboptimal asthma control the month prior to inclusion as judged by the investigator and use of over 3 inhalations of as-needed medication for symptom relief during the last 7 days before enrolment.

Are the trial subjects under 18? yes
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. Previous treatment with Symbicort Single inhaler Therapy (use of Symbicort Turbuhaler for both maintenance treatment and as-needed in response to symptoms as described in Section 3.4.1.3).
2. Use of any b-blocking agent, including eye-drops.
3. Use of oral GCS as maintenance treatment.
4. Known or suspected hypersensitivity to study therapy or excipients.
5. A history of smoking over 10 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.
7. Fertile women not using acceptable contraceptives, as judged by the investigator.
8. Any significant disease or disorder, which, in the opinion of the investigator, may put the patient at risk because of participating in the study.
9. 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.
10. Asthma exacerbation requiring change in asthma treatment during the last 14 days prior to or at Visit 1.
11. Planned in-patient hospitalisation during the course of the study.
12. 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.
13. Previous allocation of randomisation code in this study.
14. Participating in another clinical trial during the course of this study or within 30 days prior to Visit 1.
15. Involvement in the planning or conduct of this study.

Study & Design

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