Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients (MIA)
Primary Purpose
Exercise Induced Asthma
Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
budesonide
terbutaline
budesonide/formoterol
Sponsored by
About this trial
This is an interventional treatment trial for Exercise Induced Asthma focused on measuring Exercise induced asthma, Mild intermittent asthma, Exercise induced bronchoconstriction
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
Sites / Locations
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
- Research Site
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
A
B
C
Arm Description
budesonide 400yg + terbutaline 0.4 mg as-needed
placebo + terbutaline 0.4 mg as-needed
placebo + budesonide/formoterol 160/4.5 yg as-needed
Outcomes
Primary Outcome Measures
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks
FEV1
Secondary Outcome Measures
Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks
FEV1
Bronchial Responsiveness to Mannitol
Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)
Concentration of Exhaled Nitric Oxide
Use of as Needed Medication
Mean number of as needed inhalations taken before exercise
Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)
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
Asthma symptoms during days with exercise
Number of Participants With an Adverse Event During the Study
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00989833
Brief Title
Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients
Acronym
MIA
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
2. Study Status
Record Verification Date
July 2012
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
July 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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
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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Exercise Induced Asthma
Keywords
Exercise induced asthma, Mild intermittent asthma, Exercise induced bronchoconstriction
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
66 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Active Comparator
Arm Description
budesonide 400yg + terbutaline 0.4 mg as-needed
Arm Title
B
Arm Type
Active Comparator
Arm Description
placebo + terbutaline 0.4 mg as-needed
Arm Title
C
Arm Type
Active Comparator
Arm Description
placebo + budesonide/formoterol 160/4.5 yg as-needed
Intervention Type
Drug
Intervention Name(s)
budesonide
Other Intervention Name(s)
Pulmicort Turbuhaler
Intervention Description
400 yg x 1
Intervention Type
Drug
Intervention Name(s)
terbutaline
Other Intervention Name(s)
Bricanyl Turbuhaler
Intervention Description
0.4 mg as-needed
Intervention Type
Drug
Intervention Name(s)
budesonide/formoterol
Other Intervention Name(s)
Symbicort Turbuhaler
Intervention Description
160/4.5 yg as-needed
Primary Outcome Measure Information:
Title
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks
Description
FEV1
Time Frame
Baseline and Visit 6
Secondary Outcome Measure Information:
Title
Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks
Description
FEV1
Time Frame
Baseline and 3 weeks
Title
Bronchial Responsiveness to Mannitol
Description
Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)
Time Frame
Baseline and 6 weeks
Title
Concentration of Exhaled Nitric Oxide
Time Frame
6 weeks
Title
Use of as Needed Medication
Description
Mean number of as needed inhalations taken before exercise
Time Frame
6 weeks
Title
Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)
Description
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.
Time Frame
Baseline e and 6 weeks
Title
Diary Recording of Asthma Symptoms
Description
Asthma symptoms during days with exercise
Time Frame
6 weeks
Title
Number of Participants With an Adverse Event During the Study
Time Frame
6 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kjell Larsson, Professor
Organizational Affiliation
AstraZeneca MC Sweden
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georgios Stratelis
Organizational Affiliation
AstraZeneca MC Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Oslo
Country
Norway
Facility Name
Research Site
City
Trondheim
Country
Norway
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Huddinge
Country
Sweden
Facility Name
Research Site
City
Linkoping
Country
Sweden
Facility Name
Research Site
City
Lulea
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden
Facility Name
Research Site
City
Skene
Country
Sweden
Facility Name
Research Site
City
Stockholm
Country
Sweden
Facility Name
Research Site
City
Uppsala
Country
Sweden
12. IPD Sharing Statement
Citations:
PubMed Identifier
24092567
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.
Results Reference
derived
Learn more about this trial
Comparing Symbicort® As-Needed or Bricanyl As-Needed or Pulmicort® Once Daily + Bricanyl As-Needed in Asthma Patients
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