Comparing Symbicort As-Needed or Bricanyl As-Needed or Pulmicort Once Daily + Bricanyl As-Needed in Asthma Patients
Information source: AstraZeneca
Information obtained from ClinicalTrials.gov on October 04, 2010
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Exercise Induced Asthma
Intervention: budesonide (Drug); terbutaline (Drug); budesonide/formoterol (Drug)
Phase: Phase 2/Phase 3
Status: Not yet recruiting
Sponsored by: AstraZeneca Official(s) and/or principal investigator(s):
Kjell Larsson, Professor, Principal Investigator, Affiliation: AstraZeneca MC Sweden
Georgios Stratelis, Study Director, Affiliation: AstraZeneca MC Sweden
Overall contact:
AstraZeneca Clinical Study Information, Phone: +46 8 553 260 00
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
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Primary outcome: Change in post-exercise FEV1
Secondary outcome: Change in bronchial responsiveness to mannitolChange in NO in exhaled air Use of as-needed medication
Eligibility
Minimum age: 12 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
AstraZeneca Clinical Study Information, Phone: +46 8 553 260 00
Research Site, Oslo, Norway
Research Site, Trondheim, Norway
Research Site, Goteborg, Sweden
Research Site, Huddinge, Sweden
Research Site, Linkoping, Sweden
Research Site, Lulea, Sweden
Research Site, Lund, Sweden
Research Site, Skene, Sweden
Research Site, Stockholm, Sweden
Research Site, Uppsala, Sweden
Additional Information
Starting date: September 2009
Last updated: October 5, 2009
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