Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients

Study Overview
=================
Brief Summary
-----------------
The primary objective of this study is: 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 The secondary objectives of this study are: 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

Official Title
-----------------
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 Asthma

Intervention / Treatment
-----------------
* Drug: budesonide
* Drug: terbutaline
* Drug: budesonide/formoterol


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: History of exercise induced asthma Maximum 4 asthmatic episodes per week requiring use of reliever medication Exclusion Criteria: No previous treatment with inhaled oral corticosteroids during the last month before randomisation Suspected poor capability to follow instructions, ie to exercise 3-4 times a week

Ages Eligible for Study
-----------------
Minimum Age: 12 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: A<br>budesonide 400yg + terbutaline 0.4 mg as-needed | Drug: budesonide<br>* 400 yg x 1<br>* Other names: Pulmicort Turbuhaler;Drug: terbutaline<br>* 0.4 mg as-needed<br>* Other names: Bricanyl Turbuhaler;|
| Active Comparator: B<br>placebo + terbutaline 0.4 mg as-needed | Drug: terbutaline<br>* 0.4 mg as-needed<br>* Other names: Bricanyl Turbuhaler;|
| Active Comparator: C<br>placebo + budesonide/formoterol 160/4.5 yg as-needed | Drug: budesonide/formoterol<br>* 160/4.5 yg as-needed<br>* Other names: Symbicort Turbuhaler;|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks | FEV1 | Baseline and Visit 6 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks | FEV1 | Baseline and 3 weeks | 
| Bronchial Responsiveness to Mannitol | Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15) | Baseline and 6 weeks | 
| Concentration of Exhaled Nitric Oxide |  | 6 weeks | 
| Use of as Needed Medication | Mean number of as needed inhalations taken before exercise | 6 weeks | 
| Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5) | Change in overall ACQ5. ACQ5 measures asthma control and a lower values shows a better asthma control, a higher value is worse. A decrease in the ACQ5 shows an improvement during the treatment period. Range of ACQ5 is 0-5, with 0 as the best value and 5 as the worst value. Further information at www.qoltech.co.uk. | Baseline e and 6 weeks | 
| Diary Recording of Asthma Symptoms | Asthma symptoms during days with exercise | 6 weeks | 
| Number of Participants With an Adverse Event During the Study |  | 6 weeks | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Exercise induced asthma, Mild intermittent asthma, Exercise induced bronchoconstriction