CompletedPhase 2

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

Norway, Sweden66 participantsStarted 2009-09

Plain-language 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

Who can participate

Age range12 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks

Timeframe: Baseline and Visit 6

Trial details

NCT IDNCT00989833

SponsorAstraZeneca

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2010-07

Results submitted2011-08-22

View on ClinicalTrials.gov More Exercise Induced Asthma trials