Evaluation of Safety and Efficacy of Symbicort pMDI, With or Without Spacer, in Children (6-11 Years) With Asthma

This study has been completed.

First Received on September 26, 2007. Last Updated on March 28, 2008 History of Changes

Sponsor:	AstraZeneca
Information provided by:	AstraZeneca
ClinicalTrials.gov Identifier:	NCT00536913

Purpose

The purpose of the study is to compare Symbicort pMDI with and without spacer in terms of steroid potency, improvement of lung function and asthma symptoms in children with asthma (6-11 years).

Condition	Intervention	Phase
Asthma	Drug: Budesonide/formoterol pMDI 40/2.25ug + spacer Drug: Budesonide/formoterol pMDI 40/2.25 ug	Phase III

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A 4-Week, Open-Label, Randomized, Multi-Centre, Parallel-Group Study Evaluating the Safety and Efficacy of 4 Actuations Symbicort® (Budesonide/Formoterol) HFA pMDI 40/2.25 μg Twice Daily, With and Without Spacer, in Children (6-11 Years) With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Asthma

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

U.S. FDA Resources

Further study details as provided by AstraZeneca:

Primary Outcome Measures:

The primary outcome variable will be 24-hour urinary free cortisol (UFC) excretion at the end of the treatment period

Secondary Outcome Measures:

Efficacy variables will be spirometry measurements at clinic visits, morning & evening Peak Expiratory Flow (PEF), asthma symptoms, night-time awakenings due to asthma & use of reliever medication recorded in daily diary.

Estimated Enrollment:	100
Study Start Date:	September 2007
Primary Completion Date:	March 2008 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Years to 11 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

children 6-11 years, diagnosed asthma treated
6 months, PEF
50% of predicted normal value pre-bronchodilator

Exclusion Criteria:

current systemic glucocorticosteroids usage
current respiratory infection
any significant disease or disorder as judged by investigator

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00536913

Locations

Hungary
Research Site
Budapest, Hungary
Research Site
Debrecen, Hungary
Research Site
Kaposvar, Hungary
Poland
Research Site
Biaystok, Poland
Research Site
Bydgoszcz, Poland
Research Site
Bytom, Poland
Research Site
Karpacz, Poland
Research Site
Krakow, Poland
Research Site
Od, Poland
Research Site
Warszawa, Poland
Russian Federation
Research Site
Moscow, Russian Federation

Sponsors and Collaborators

AstraZeneca

Investigators

Study Director:	Tomas Anderson, MD PhD	AstraZeneca
Principal Investigator:	Piotr Kuna, MD PhD	Uniwersytecki Spital

More Information

No publications provided

ClinicalTrials.gov Identifier:	NCT00536913 History of Changes
Other Study ID Numbers:	D5897C00004
Study First Received:	September 26, 2007
Last Updated:	March 28, 2008
Health Authority:	Hungary: National Institute of Pharmacy; Poland: Ministry of Health; Russia: Ministry of Health and Social Welfare

Keywords provided by AstraZeneca:

Symbicort pMDI
spacer
children

Additional relevant MeSH terms:

Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
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
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on February 09, 2012