A randomised, double blind, placebo controlled, parallel-group study with use of budesonide/formoterol as-needed”, or terbutaline as-needed” or regular use of budesonide + terbutaline as-needed”, in patients with mild intermittent asthma
- Conditions
- Exercise induced bronchoconstrictionMedDRA version: 9.1Level: LLTClassification code 10015649Term: Exercise induced asthma
- Registration Number
- EUCTR2009-012805-20-SE
- Lead Sponsor
- AstraZeneca AB
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Recruiting
- Sex
- All
- Target Recruitment
- Not specified
For inclusion in the study patients must fulfil the following criteria:
1. Provision of informed consent prior to any study specific procedures
2. Out-patients, male or female ³ 12 years
3. History of exercise induced asthma according to GINA guidelines (GINA, guidelines)
4. Anamnesis of maximum 4 symptomatic asthma episodes per week requiring use of reliever medication (including use for prevention)
5. Baseline FEV1 at Visit 1 should be = 80.0% of predicted normal value according to European Community for Steel and Coal (Quanjer et al.1993) for adults and according to Solymar (Solymar et al. Eur J Respir Dis 1980;61:275-286) for children, 12-18 years. If FEV1 is between 75.0-80.0%, a reversibility test can be done with salbutamol, 0.4 mg. If FEV1 15 minutes after salbutamol inhalation has increased < 12.0% (<200 ml) compared to pre-inhalation, the patient can proceed with the maximal exercise test. If FEV1 15 minutes after salbutamol inhalation has increased > 12.0% (>200 ml) compared to pre-inhalation, the patient will be discontinued.
Inclusion criteria at Visit 3 (randomisation visit)
6. A fall of ³ 10.0% in FEV1 following a standardized ECT at Visit 2
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) no
F.1.3.1 Number of subjects for this age range
Patients must not enter the study if any of the following exclusion criteria are fulfilled:
1. Previous treatment with inhaled or oral corticosteroids during the last month and/or intravenous corticosteroids = 2 months before randomisation
2. Indication for regular maintenance treatment with anti-inflammatory asthma medication, i.e. corticosteroids, disodium cromoglycate and leukotriene antagonist according to the Investigators judgement
3. Known or suspected hypersensitivity to b2-agonists, inhaled corticosteroids or inhaled lactose
4. b-blocker therapy (including eye drops)
5. Any treatment for a concomitant disease that may affect the participation in or results of the study
6. 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 influence the results of the study, or the patients ability to participate in the study
7. Any clinically relevant abnormal findings in physical examination, vital signs at baseline visit, which, in the opinion of the investigator, may put the patient at risk because of his/her participation in the study
8. Pregnancy, breast feeding, planned pregnancy during the study and fertile women not using acceptable contraceptive measures, as judged by the investigator.
9. Suspected poor capability to follow instructions of the study, e.g. because of a history of drug abuse, difficult to read and/or understand Swedish or any other reason, as judged by the investigator
10. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site)
11. Previous randomisation of treatment in the present study
12. Participation in another clinical study 30 days prior to and during this study
13. Current smoker or stopped smoking < 1 year ago
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method