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

AstraZeneca

Status and phase: Completed; Phase 2

Conditions: Exercise Induced Asthma

Treatments: Drug: terbutaline; Drug: budesonide/formoterol; Drug: budesonide

Study type: Interventional

Funder types: Industry

Identifiers

NCT00989833

D5890L00032

Details and patient eligibility

About

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

Enrollment: 66 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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66 participants in 3 patient groups

A

Active Comparator group

Description:

budesonide 400yg + terbutaline 0.4 mg as-needed

Treatment:

Drug: budesonide

Drug: terbutaline

B

Active Comparator group

Description:

placebo + terbutaline 0.4 mg as-needed

Treatment:

Drug: terbutaline

C

Active Comparator group

Description:

placebo + budesonide/formoterol 160/4.5 yg as-needed

Treatment:

Drug: budesonide/formoterol