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:
Information provided by (Responsible Party):
AstraZeneca
ClinicalTrials.gov Identifier:
NCT00989833
First received: September 30, 2009
Last updated: July 6, 2012
Last verified: July 2012
  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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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 ] [ Designated as safety issue: No ]
    FEV1


Secondary Outcome Measures:
  • Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks [ Time Frame: Baseline and 3 weeks ] [ Designated as safety issue: No ]
    FEV1

  • Bronchial Responsiveness to Mannitol [ Time Frame: Baseline and 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Use of as Needed Medication [ Time Frame: 6 weeks ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Asthma symptoms during days with exercise

  • Number of Participants With an Adverse Event During the Study [ Time Frame: 6 weeks ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by AstraZeneca

Additional 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
Study First Received: September 30, 2009
Results First Received: August 22, 2011
Last Updated: July 6, 2012
Health Authority: Norway: Norwegian Medicines Agency
Sweden: Medical Products Agency

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
Terbutaline
Budesonide
Formoterol
Symbicort
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on July 29, 2014