A comparison of Symbicort Single inhaler Therapy (Symbicort Turbohaler 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, multi-centre study (SALTO) - SALTO
- Conditions
- persistent asthmaMedDRA version: 7.0Classification code 10003553
- Registration Number
- EUCTR2004-001107-36-BE
- Lead Sponsor
- AstraZeneca NV/SA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 1200
For inclusion in the study patients must fulfil all of the following criteria at Visit 1:
1.Provision of written informed consent. This must have been obtained before conducting any study related procedures. For underage patients, informed consent from both patient and the patient’s parent/legal guardian must be obtained. Female or male outpatients aged ³12 years.
2.Minimum of 3 months documented history of asthma, diagnosed according to the American Thoracic Society (ATS) definition (Error! Reference source not found.).
3.Prescribed inhaled GCS at a dose of ³320 µg/day and within the approved label for the relevant drug during the last 3 months prior to Visit 1.
4.Either
- daily maintenance treatment with both inhaled GCS and long-acting b2-agonist (LABA)
or
- daily treatment with inhaled GCS alone (i.e. without LABA) and a history of sub optimal asthma control the month prior to enrolment as judged by the investigator and use of ³3 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
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 Turbohaler for both maintenance treatment and as needed in response to symptoms as described in Section Error! Reference source not found.).
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 ³ 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. 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
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective is to compare the efficacy of Symbicort Single inhaler Therapy with treatment according to conventional best practice in adolescent and adult patients with persistent asthma.<br>The primary outcome variable is: time to first severe asthma exacerbation. <br>;Secondary Objective: A secondary objective is to collect safety data for treatment in the two treatment groups in adolescent and adult patients with persistent asthma, by evaluating the incidence and types of serious adverse events and discontinuations due to adverse events;Primary end point(s): The primary outcome variable is: time to first severe asthma exacerbation.
- Secondary Outcome Measures
Name Time Method