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

Exercise Induced Asthma Clinical Trial

— MIA  

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989833
• Other study ID #: D5890L00032
• Status: Completed
• Phase: Phase 2
• First received: September 30, 2009
• Last updated: July 6, 2012
• Start date: September 2009
• Est. completion date: July 2010

Study information

• Verified date: July 2012
• Source: AstraZeneca
• Contact: n/a
• Is FDA regulated: No
• Health authority: Norway: Norwegian Medicines AgencySweden: Medical Products Agency
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 66
• Est. completion date: July 2010
• Est. primary completion date: July 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma
• Asthma, Exercise-Induced
• Exercise Induced Asthma

Intervention

Drug:
• budesonide
400 yg x 1
• terbutaline
0.4 mg as-needed
• budesonide/formoterol
160/4.5 yg as-needed

Locations

Country	Name	City	State
Norway	Research Site	Oslo
Norway	Research Site	Trondheim
Sweden	Research Site	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

Sponsors (1)

Lead Sponsor	Collaborator
AstraZeneca

Countries where clinical trial is conducted

Norway,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent Change in Maximum Post-exercise Forced Expiratory Volume in One Second (FEV1) Fall After 6 Weeks	FEV1	Baseline and Visit 6	No
Secondary	Percent Change in Maximum Post-exercise FEV1 Fall After 3 Weeks	FEV1	Baseline and 3 weeks	No
Secondary	Bronchial Responsiveness to Mannitol	Change in cumulative Mannitol dose in mg in patients with a positive mannitol provocation test at baseline (PD15)	Baseline and 6 weeks	No
Secondary	Concentration of Exhaled Nitric Oxide		6 weeks	No
Secondary	Use of as Needed Medication	Mean number of as needed inhalations taken before exercise	6 weeks	No
Secondary	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.	Baseline e and 6 weeks	No
Secondary	Diary Recording of Asthma Symptoms	Asthma symptoms during days with exercise	6 weeks	No
Secondary	Number of Participants With an Adverse Event During the Study		6 weeks	Yes