Phase 2
Completed N=66
Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients
Exercise Induced Asthma
Source: ClinicalTrials.gov NCT00989833 ↗
Enrolled (actual)
66
Serious AEs
0.0%
Results posted
Aug 2012
Primary outcomePrimary: Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks — -5.85; 0.61; -5.24 Percent change
Summary
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
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks |
-5.85; 0.61; -5.24 | — |
| SECONDARY Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks |
-4.07; -1.19; -3.81 | — |
| SECONDARY Bronchial Responsiveness to Mannitol |
67.26; -6.15; 151.87 | — |
| SECONDARY Concentration of Exhaled Nitric Oxide |
25.9; 35.5; 24.4 | — |
| SECONDARY Use of as Needed Medication |
0.6; 0.8; 0.7 | — |
| SECONDARY Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5) |
-0.3; -0.2; -0.4 | — |
| SECONDARY Diary Recording of Asthma Symptoms |
51.1; 50.9; 49.8 | — |
| SECONDARY Number of Participants With an Adverse Event During the Study |
13; 13; 13 | — |
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
Data sourced from ClinicalTrials.gov (NCT00989833). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.