Exercise Induced Asthma Clinical Trial
— MIAOfficial 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
1. 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
2. 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
Status | Completed |
Enrollment | 66 |
Est. completion date | July 2010 |
Est. primary completion date | July 2010 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 12 Years and older |
Eligibility |
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 |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
Norway | Research Site | Oslo | |
Norway | Research Site | Trondheim | |
Sweden | Research Site | Goteborg | |
Sweden | Research Site | Huddinge | |
Sweden | Research Site | Linkoping | |
Sweden | Research Site | Lulea | |
Sweden | Research Site | Lund | |
Sweden | Research Site | Skene | |
Sweden | Research Site | Stockholm | |
Sweden | Research Site | Uppsala |
Lead Sponsor | Collaborator |
---|---|
AstraZeneca |
Norway, Sweden,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks | FEV1 | Baseline and Visit 6 | No |
Secondary | Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks | FEV1 | Baseline and 3 weeks | No |
Secondary | 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 | No |
Secondary | Concentration of Exhaled Nitric Oxide | 6 weeks | No | |
Secondary | Use of as Needed Medication | Mean number of as needed inhalations taken before exercise | 6 weeks | No |
Secondary | 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 | No |
Secondary | Diary Recording of Asthma Symptoms | Asthma symptoms during days with exercise | 6 weeks | No |
Secondary | Number of Participants With an Adverse Event During the Study | 6 weeks | Yes |
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