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”

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

Study Type: Interventional

Study Design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Intervention(s) in this Clinical Trial

• Drug: budesonide
  • 400 yg x 1
• Drug: terbutaline
  • 0.4 mg as-needed
• Drug: budesonide/formoterol
  • 160/4.5 yg as-needed

Arms, Groups and Cohorts in this Clinical Trial

• Active Comparator: A
  • budesonide 400yg + terbutaline 0.4 mg as-needed
• Active Comparator: B
  • placebo + terbutaline 0.4 mg as-needed
• Active Comparator: C
  • placebo + budesonide/formoterol 160/4.5 yg as-needed

Primary Measures

• Change in post-exercise FEV1
  • Time Frame: Day -6-2, day 21 and day 42
    Safety Issue?: Yes

Secondary Measures

• Change in bronchial responsiveness to mannitol
  • Time Frame: Day 0 and day 42
    Safety Issue?: Yes
• Change in NO in exhaled air
  • Time Frame: Day -6-2, day 0, day 21, day 42, day 42 + 2-5 days
    Safety Issue?: Yes
• Use of as-needed medication
  • Time Frame: Day 0 - day 42
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 12 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: AstraZeneca

Overall Clinical Trial Officials and Contacts

Kjell Larsson, Professor Principal Investigator AstraZeneca MC Sweden  

Overall Contact: AstraZeneca Clinical Study Information +46 8 553 260 00 

Information obtained from ClinicalTrials.gov on September 07, 2010

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00989833

Study ID Number: D5890L00032

ClinicalTrials.gov Identifier: NCT00989833

Health Authority: Norway: Norwegian Medicines Agency