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

Phase 2

Completed

• Conditions: Exercise Induced Asthma
• Interventions: Drug: budesonide/formoterol; Drug: budesonide; Drug: terbutaline

• Registration Number: NCT00989833
• Lead Sponsor: AstraZeneca

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

Detailed Description

Not available

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-09-30
• Study First Submitted QC: 2009-10-05
• Study First Posted: 2009-10-06
• Primary Completion: 2010-07
• Study Completion: 2010-07
• Results First Submitted: 2011-08-22
• Status Verified: 2012-07
• Results First Submitted QC: 2012-07-06
• Last Update Submitted: 2012-07-06
• Results First Posted: 2012-08-14
• Last Update Posted: 2012-08-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 66

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
C	budesonide/formoterol	placebo + budesonide/formoterol 160/4.5 yg as-needed
A	budesonide	budesonide 400yg + terbutaline 0.4 mg as-needed
B	terbutaline	placebo + terbutaline 0.4 mg as-needed
A	terbutaline	budesonide 400yg + terbutaline 0.4 mg as-needed

Primary Outcome Measures

Name	Time	Method
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks	Baseline and Visit 6	FEV1

Secondary Outcome Measures

Name	Time	Method
Concentration of Exhaled Nitric Oxide	6 weeks
Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks	Baseline and 3 weeks	FEV1
Bronchial Responsiveness to Mannitol	Baseline and 6 weeks	Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)
Use of as Needed Medication	6 weeks	Mean number of as needed inhalations taken before exercise
Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)	Baseline e and 6 weeks	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.
Diary Recording of Asthma Symptoms	6 weeks	Asthma symptoms during days with exercise
Number of Participants With an Adverse Event During the Study	6 weeks

Trial Locations

Locations (1)

Research Site; 🇸🇪 Uppsala, Sweden