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Completed

NCT Number: NCT00989833

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

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

Completed

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Key information

Conditions

Exercise Induced Asthma Asthma Asthma, Exercise-Induced Bronchial Diseases Exercise-Induced Allergies Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Research Site, Oslo, Norway

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Budesonide

Drug

400 yg x 1

Other names: Pulmicort Turbuhaler

Terbutaline

Drug

0.4 mg as-needed

Other names: Bricanyl Turbuhaler

budesonide/formoterol

Drug

160/4.5 yg as-needed

Other names: Symbicort Turbuhaler

Primary outcomes

  1. 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 outcomes

  1. Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks

    Time frame: Baseline and 3 weeks

    FEV1

  2. 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)

  3. Concentration of Exhaled Nitric Oxide

    Time frame: 6 weeks

  4. Use of as Needed Medication

    Time frame: 6 weeks

    Mean number of as needed inhalations taken before exercise

  5. 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.

  6. Diary Recording of Asthma Symptoms

    Time frame: 6 weeks

    Asthma symptoms during days with exercise

  7. Number of Participants With an Adverse Event During the Study

    Time frame: 6 weeks

Sponsors and collaborators

Lead sponsor

AstraZeneca

Industry

Registry information

Official study 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

Acronym: MIA

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Oct 6, 2009
Registry last updated
Aug 14, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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