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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00989833
First Posted: October 6, 2009
Last Update Posted: August 14, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
AstraZeneca
  Purpose
  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

Condition Intervention Phase
Exercise Induced Asthma Drug: budesonide Drug: terbutaline Drug: budesonide/formoterol Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by AstraZeneca:

Primary Outcome Measures:
  • Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks [ Time Frame: Baseline and Visit 6 ]
    FEV1


Secondary Outcome Measures:
  • Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks [ Time Frame: Baseline and 3 weeks ]
    FEV1

  • Bronchial Responsiveness to Mannitol [ Time Frame: Baseline and 6 weeks ]
    Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)

  • Concentration of Exhaled Nitric Oxide [ Time Frame: 6 weeks ]
  • Use of as Needed Medication [ Time Frame: 6 weeks ]
    Mean number of as needed inhalations taken before exercise

  • Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5) [ Time Frame: 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 [ Time Frame: 6 weeks ]
    Asthma symptoms during days with exercise

  • Number of Participants With an Adverse Event During the Study [ Time Frame: 6 weeks ]

Enrollment: 66
Study Start Date: September 2009
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: A
budesonide 400yg + terbutaline 0.4 mg as-needed
Drug: budesonide
400 yg x 1
Other Name: Pulmicort Turbuhaler
Drug: terbutaline
0.4 mg as-needed
Other Name: Bricanyl Turbuhaler
Active Comparator: B
placebo + terbutaline 0.4 mg as-needed
Drug: terbutaline
0.4 mg as-needed
Other Name: Bricanyl Turbuhaler
Active Comparator: C
placebo + budesonide/formoterol 160/4.5 yg as-needed
Drug: budesonide/formoterol
160/4.5 yg as-needed
Other Name: Symbicort Turbuhaler

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00989833


Locations
Norway
Research Site
Oslo, Norway
Research Site
Trondheim, Norway
Sweden
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
Sponsors and Collaborators
AstraZeneca
Investigators
Principal Investigator: Kjell Larsson, Professor AstraZeneca MC Sweden
Study Director: Georgios Stratelis AstraZeneca MC Sweden
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: AstraZeneca
ClinicalTrials.gov Identifier: NCT00989833     History of Changes
Other Study ID Numbers: D5890L00032
First Submitted: September 30, 2009
First Posted: October 6, 2009
Results First Submitted: August 22, 2011
Results First Posted: August 14, 2012
Last Update Posted: August 14, 2012
Last Verified: July 2012

Keywords provided by AstraZeneca:
Exercise induced asthma
Mild intermittent asthma
Exercise induced bronchoconstriction

Additional relevant MeSH terms:
Asthma
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Formoterol Fumarate
Budesonide
Terbutaline
Budesonide, Formoterol Fumarate Drug Combination
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists