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

AstraZeneca66 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Exercise Induced Asthma

Interventions

Eligibility

Sex: ALLMin age: 12 Years

Medical Language ↔ Plain English

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

Locations (10)

Research Site

Oslo, Norway

Research Site

Trondheim, Norway

Research Site

Gothenburg, Sweden

Research Site

Huddinge, Sweden

Research Site

Linköping, Sweden

Research Site

Luleå, Sweden

Research Site

Lund, Sweden

Research Site

Skene, Sweden

Research Site

Stockholm, Sweden

Research Site

Uppsala, Sweden

Outcomes

Primary Outcomes

Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks

FEV1

Time frame: Baseline and Visit 6

Secondary Outcomes

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

FEV1

Time frame: Baseline and 3 weeks

Bronchial Responsiveness to Mannitol

Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)

Time frame: Baseline and 6 weeks

Concentration of Exhaled Nitric Oxide

Time frame: 6 weeks

Use of as Needed Medication

Mean number of as needed inhalations taken before exercise

Time frame: 6 weeks

Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)

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.

Time frame: Baseline e and 6 weeks

Diary Recording of Asthma Symptoms

Asthma symptoms during days with exercise

Time frame: 6 weeks

Number of Participants With an Adverse Event During the Study

Time frame: 6 weeks