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”

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

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 Investigator: AstraZeneca Industry

Overall Clinical Trial Officials and Contacts

Kjell Larsson, Professor Principal Investigator AstraZeneca MC Sweden  

Information obtained from ClinicalTrials.gov on February 08, 2012

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