Clinical trial NCT00989833: Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Exercise Induced Asthma
Keywords: Exercise induced asthma
Mild intermittent asthma
Exercise induced bronchoconstriction
Lead sponsor: AstraZeneca
Sponsor class: INDUSTRY
First posted: 2009-10-06
Enrollment: 66
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Primary outcomes:
measure: Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks
timeFrame: Baseline and Visit 6
Secondary outcomes:
measure: Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks
timeFrame: Baseline and 3 weeks
measure: Bronchial Responsiveness to Mannitol
timeFrame: Baseline and 6 weeks
measure: Concentration of Exhaled Nitric Oxide
timeFrame: 6 weeks
measure: Use of as Needed Medication
timeFrame: 6 weeks
measure: Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)
timeFrame: Baseline e and 6 weeks
measure: Diary Recording of Asthma Symptoms
timeFrame: 6 weeks
measure: Number of Participants With an Adverse Event During the Study
timeFrame: 6 weeks
Other outcomes:
Locations:
city: Oslo
country: Norway
facility: Research Site
city: Trondheim
country: Norway
facility: Research Site
city: Goteborg
country: Sweden
facility: Research Site
city: Huddinge
country: Sweden
facility: Research Site
city: Linkoping
country: Sweden
facility: Research Site
city: Lulea
country: Sweden
facility: Research Site
city: Lund
country: Sweden
facility: Research Site
city: Skene
country: Sweden
facility: Research Site
city: Stockholm
country: Sweden
facility: Research Site
city: Uppsala
country: Sweden
facility: Research Site
Study officials:
affiliation: AstraZeneca MC Sweden
name: Kjell Larsson, Professor
role: PRINCIPAL_INVESTIGATOR
affiliation: AstraZeneca MC Sweden
name: Georgios Stratelis
role: STUDY_DIRECTOR
References:
citation: Lazarinis N, Jorgensen L, Ekstrom T, Bjermer L, Dahlen B, Pullerits T, Hedlin G, Carlsen KH, Larsson K. Combination of budesonide/formoterol on demand improves asthma control by reducing exercise-induced bronchoconstriction. Thorax. 2014 Feb;69(2):130-6. doi: 10.1136/thoraxjnl-2013-203557. Epub 2013 Oct 3.