Comparing Symbicort As-Needed or Bricanyl As-Needed or Pulmicort Once Daily + Bricanyl As-Needed in Asthma Patients - Full Text View

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00989833

Purpose

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
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

Condition	Intervention	Phase
Exercise Induced Asthma	Drug: budesonide Drug: terbutaline Drug: budesonide/formoterol	Phase II

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

Resource links provided by NLM:

MedlinePlus related topics: Asthma Exercise and Physical Fitness

Drug Information available for: Terbutaline Terbutaline sulfate Formoterol fumarate Budesonide Arformoterol Formoterol Symbicort Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

Change in post-exercise FEV1 [ Time Frame: Day -6-2, day 21 and day 42 ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:

Change in bronchial responsiveness to mannitol [ Time Frame: Day 0 and day 42 ] [ Designated as safety issue: Yes ]
Change in NO in exhaled air [ Time Frame: Day -6-2, day 0, day 21, day 42, day 42 + 2-5 days ] [ Designated as safety issue: Yes ]
Use of as-needed medication [ Time Frame: Day 0 - day 42 ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	65
Study Start Date:	September 2009
Study Completion Date:	July 2010
Primary Completion Date:	July 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: A budesonide 400yg + terbutaline 0.4 mg as-needed	Drug: budesonide 400 yg x 1 Other Name: Pulmicort Turbuhaler Drug: terbutaline 0.4 mg as-needed Other Name: Bricanyl Turbuhaler
Active Comparator: B placebo + terbutaline 0.4 mg as-needed	Drug: terbutaline 0.4 mg as-needed Other Name: Bricanyl Turbuhaler
Active Comparator: C placebo + budesonide/formoterol 160/4.5 yg as-needed	Drug: budesonide/formoterol 160/4.5 yg as-needed Other Name: Symbicort Turbuhaler

Eligibility

Ages Eligible for Study:	12 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989833

Locations

Norway
Research Site
Oslo, Norway
Research Site
Trondheim, Norway
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, Sweden

Sponsors and Collaborators

AstraZeneca

Investigators

Principal Investigator:	Kjell Larsson, Professor	AstraZeneca MC Sweden
Study Director:	Georgios Stratelis	AstraZeneca MC Sweden

More Information

No publications provided

Responsible Party:	MC MD, AstraZeneca
ClinicalTrials.gov Identifier:	NCT00989833 History of Changes
Other Study ID Numbers:	D5890L00032
Study First Received:	September 30, 2009
Last Updated:	December 2, 2010
Health Authority:	Norway: Norwegian Medicines Agency; Sweden: Medical Products Agency

Keywords provided by AstraZeneca:

Exercise induced asthma
Mild intermittent asthma
Exercise induced bronchoconstriction

Additional relevant MeSH terms:

Asthma
Asthma, Exercise-Induced
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Terbutaline
Budesonide
Formoterol
Symbicort
Bronchodilator Agents

Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Sympathomimetics
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents

ClinicalTrials.gov processed this record on February 09, 2012