Phase 2 N=66 Randomized Double-blind Treatment

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

Exercise Induced Asthma

Bottom Line

View on ClinicalTrials.gov: NCT00989833 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2012

Primary outcome: Primary: 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

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: budesonide (Drug); terbutaline (Drug); budesonide/formoterol (Drug)
Age: Pediatric, Adult, Older Adult · 12+ yrs
Sex: All
Sponsor: AstraZeneca
Primary completion: Jul 2010

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	—

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

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

View full record on ClinicalTrials.gov →

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.