Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma - Full Text View

Sponsor:	Medical Universtity of Lodz
Information provided by:	Medical Universtity of Lodz
ClinicalTrials.gov Identifier:	NCT00490243

Purpose

The present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique, plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and clinical symptoms.

Condition	Intervention	Phase
Asthma	Drug: budesonide and montelukast Drug: budesonide and formoterol Drug: montelukast Drug: budesonide Drug: placebo	Phase IV

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment
Official Title:	A Randomized, Double-Blind Trial of the Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma

Resource links provided by NLM:

MedlinePlus related topics: Allergy Asthma Exercise and Physical Fitness

Drug Information available for: Formoterol fumarate Budesonide Arformoterol Formoterol Montelukast sodium Montelukast Arformoterol Tartrate

U.S. FDA Resources

Further study details as provided by Medical Universtity of Lodz:

Primary Outcome Measures:

FEF25-75%, Rint, sRaw, FEV1, PEFR, maximum percentage fall in FEV1 after exercise test, the area under the curve (AUC) for the FEV1 values over the 20-min period from exercise [ Time Frame: baseline (second visit) and after 4 weeks of treatment (third visit) ]

Secondary Outcome Measures:

symptoms score [ Time Frame: baseline (second visit) and after 4 weeks of treatment (third visit) ]

Enrollment:	150
Study Start Date:	July 2003
Study Completion Date:	October 2006

Detailed Description:

Asthma is one of the most common chronic disease worldwide, imposing a substantial social burden on children. Allergic inflammation is responsible for all clinical symptoms of asthma. The effects of allergic inflammation are: bronchial muscle constriction, excessive mucus production, and edema of mucosa, all elements of „asthmatic triad” causing bronchial obturation. Normal lung function is one of the goals of asthma management. In most of the studies the effect of monotherapy on the symptom scores, lung function parameters and bronchial hyperreactivity was assessed.

The present study was conducted to determine the effects of four week treatment with budesonide, montelukast, budesonide with montelukast and budesonide with formoterol in children with atopic asthma on lung function: forced expiratory volume in one second, mid-expiratory flow, peak expiratory flow rate, resistance by the interrupter technique, plethysmographic specific airway resistance, exercise-induced bronchial hyperreactivity and clinical symptoms.

Eligibility

Ages Eligible for Study:	6 Years to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Male and female outpatients
Aged 6 to 18 with a clinical diagnosis of bronchial asthma with a duration of at least 6 months before the first visit and with current history of moderate persistent asthma
Sensitive to house dust mites as shown by positive skin-prick tests to Dermatophagoides pteronyssinus or Dermatophagoides farinae
To become eligible for the active treatment period, patients and their parents were required to do reproducible spirometry, whole body plethysmography and interrupter technique.
In order to be included in the study the patients had to have a resting FEV1 of more or equal 70%.

Exclusion Criteria:

Study exclusions included:

Active upper respiratory tract infection within 3 weeks before the study and acute sinus disease requiring antibiotic treatment within 1 month before the study
Previous intubation
Asthma hospitalisation during the 3 months before the first visit.
Additional criteria were other clinically significant pulmonary, hematologic, hepatic, gastrointestinal, renal, endocrine, neurologic, cardiovascular, and/or psychiatric diseases or malignancy that either put the patient at risk when participating in the study or could influence the results of the study or the patient's ability to participate in the study as judged by the investigator.
Excluded medications were β-blockers (eye drops included), astemizole within 3 months, or oral corticosteroids within 1 month before the first visit.
Patients who were receiving immunotherapy were also excluded.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00490243

Locations

Poland
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Lodz, Poland, 93-513

Sponsors and Collaborators

Medical Universtity of Lodz

Investigators

Principal Investigator:	Tomasz Grzelewski, MD, PhD	Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Study Chair:	Iwona Stelmach, MD, PhD, Prof	Department of Pediatrics and Allergy, Medical University of Lodz, Poland

More Information

Publications:

Stelmach I, Grzelewski T, Bobrowska-Korzeniowska M, Stelmach P, Kuna P. A randomized, double-blind trial of the effect of anti-asthma treatment on lung function in children with asthma. Pulm Pharmacol Ther. 2006 Sep 14; [Epub ahead of print]

ClinicalTrials.gov Identifier:	NCT00490243 History of Changes
Other Study ID Numbers:	RNN/135/03/KE
Study First Received:	June 21, 2007
Last Updated:	June 27, 2007
Health Authority:	Poland: Ministry of Health

Keywords provided by Medical Universtity of Lodz:

Asthma
Children
Exercise
Pulmonary Function

Budesonide
Montelukast
Formoterol

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
Anti-Asthmatic Agents
Montelukast
Bronchodilator Agents
Autonomic Agents

Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
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