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

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

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00989833

Acronym

MIA

Enrollment

Registered

2009-10-06

Start date

2009-09-30

Completion date

2010-07-31

Last updated

2012-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Exercise Induced Asthma

Keywords

Exercise induced asthma, Mild intermittent asthma, Exercise induced bronchoconstriction

Brief summary

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

Interventions

DRUGbudesonide

400 yg x 1

DRUGterbutaline

0.4 mg as-needed

DRUGbudesonide/formoterol

160/4.5 yg as-needed

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

12 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Bronchial Responsiveness to Mannitol	Baseline and 6 weeks	Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)
Concentration of Exhaled Nitric Oxide	6 weeks	—
Use of as Needed Medication	6 weeks	Mean number of as needed inhalations taken before exercise
Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks	Baseline and 3 weeks	FEV1
Diary Recording of Asthma Symptoms	6 weeks	Asthma symptoms during days with exercise
Number of Participants With an Adverse Event During the Study	6 weeks	—
Asthma Control Measured by a 5-item Asthma Control Questionnaire (ACQ5)	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.

Countries

Norway, Sweden

Participant flow

Recruitment details

On Visit 1, a total of 189 patients, aged 12-67, were enrolled at 10 study sites in 2 countries: Sweden and Norway. Of 189 enrolled patients, 66 patients were randomized and allocated to study treatment on Visit 3 (7 patients in Norway and 59 patients in Sweden).

Pre-assignment details

A standardized exercise test (ECT) with duration of 6 minutes, at approximately 90% of maximal aerobic capacity (as defined on Visit 1) was performed on a treadmill while breathing dry air on Visit 2. Patients with exercised induced bronchoconstriction (defined as fall in FEV1 ≥ 10% ) could be randomized on Visit 3.

Participants by arm

Arm	Count
Budesonide/Terbutaline Budesonide once daily and terbutaline before exercise and as needed	21
Terbutaline Placebo budesonide once daily and terbutaline before exercise and as needed	22
Budesonide/Formoterol Placebo budesonide once daily and budesonide/formoterol before exercise and as needed	23
Total	66

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Overall Study	Incorrectly randomized	1	0	0
Overall Study	Lost to Follow-up	0	1	0
Overall Study	Protocol Violation	1	2	1
Overall Study	Withdrawal by Subject	0	0	1

Baseline characteristics

Characteristic	Budesonide/Terbutaline	Terbutaline	Budesonide/Formoterol	Total
Age, Categorical <=18 years	2 Participants	5 Participants	5 Participants	12 Participants
Age, Categorical >=65 years	1 Participants	1 Participants	0 Participants	2 Participants
Age, Categorical Between 18 and 65 years	18 Participants	16 Participants	18 Participants	52 Participants
Sex: Female, Male Female	10 Participants	6 Participants	14 Participants	30 Participants
Sex: Female, Male Male	11 Participants	16 Participants	9 Participants	36 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk	EG002 affected / at risk
deaths Total, all-cause mortality	— / —	— / —	— / —
other Total, other adverse events	7 / 21	10 / 22	9 / 23
serious Total, serious adverse events	0 / 21	0 / 22	0 / 23

Outcome results

Primary