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

July 6, 2012 updated by: AstraZeneca

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

66

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Norway
      • Oslo, Norway
        • Research Site
      • Trondheim, Norway
        • Research Site
  • Sweden
      • 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
        • Research Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

12 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: A
budesonide 400yg + terbutaline 0.4 mg as-needed
Drug: budesonide
400 yg x 1
Other Names:
  • Pulmicort Turbuhaler
Drug: terbutaline
0.4 mg as-needed
Other Names:
  • Bricanyl Turbuhaler
Active Comparator: B
placebo + terbutaline 0.4 mg as-needed
Drug: terbutaline
0.4 mg as-needed
Other Names:
  • Bricanyl Turbuhaler
Active Comparator: C
placebo + budesonide/formoterol 160/4.5 yg as-needed
Drug: budesonide/formoterol
160/4.5 yg as-needed
Other Names:
  • Symbicort Turbuhaler

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks
Time Frame: Baseline and Visit 6
FEV1
Baseline and Visit 6

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks
Time Frame: Baseline and 3 weeks
FEV1
Baseline and 3 weeks
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)
Baseline and 6 weeks
Concentration of Exhaled Nitric Oxide
Time Frame: 6 weeks
6 weeks
Use of as Needed Medication
Time Frame: 6 weeks
Mean number of as needed inhalations taken before exercise
6 weeks
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.
Baseline e and 6 weeks
Diary Recording of Asthma Symptoms
Time Frame: 6 weeks
Asthma symptoms during days with exercise
6 weeks
Number of Participants With an Adverse Event During the Study
Time Frame: 6 weeks
6 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AstraZeneca

Investigators

  • Principal Investigator: Kjell Larsson, Professor, AstraZeneca MC Sweden
  • Study Director: Georgios Stratelis, AstraZeneca MC Sweden

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

July 1, 2010

Study Completion (Actual)

July 1, 2010

Study Registration Dates

First Submitted

September 30, 2009

First Submitted That Met QC Criteria

October 5, 2009

First Posted (Estimate)

October 6, 2009

Study Record Updates

Last Update Posted (Estimate)

August 14, 2012

Last Update Submitted That Met QC Criteria

July 6, 2012

Last Verified

July 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D5890L00032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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