Exercise induced bronchoconstriction MedDRA version: 9.1 Level: LLT Classification code 10015649 Term: Exercise induced asthma
Conditions
Interventions
Trade Name: Symbicort Turbuhaler 160 mikrogram/4,5 mikrogram/inhalation inhalationspulver
Pharmaceutical Form: Inhalation powder
INN or Proposed INN: BUDESONIDE
CAS Number: 51333223
Concentration unit
Sponsors
AstraZeneca AB
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 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 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol on an as-needed basis compared to the use of terbutaline as-needed on Exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma;Secondary Objective: To evaluate the magnitude of the protective effect of the combination of budesonide and formoterol as-needed compared to regular once daily use of budesonide plus terbutaline as-needed on exercise induced bronchoconstriction in adults and adolescents with mild intermittent asthma To evaluate safety of budesonide/formoterol as-needed, terbutaline as-needed and regular use of budesonide + terbutaline as-needed as terms of adverse event ;Primary end point(s): The combination of budesonide and formoterol used as prevention before exercise is more effective than standard treatment (b2-agonist) in protecting against exercise-induced bronchoconstriction. The combination of budesonide and formoterol used as prevention before exercise is as effective as regular treatment with budesonide in protecting against exercise-induced bronchoconstriction. | — |
Countries
Sweden
Outcome results
None listed