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

NCT00490243 | Completed Phase 4 DMC

• 1 other identifier: RNN/135/03/KE
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Asthma

Keywords

Asthma; Children; Exercise; Pulmonary Function; Budesonide; Montelukast; Formoterol

Outcome Measures

Primary Outcomes (1)

• 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

  baseline (second visit) and after 4 weeks of treatment (third visit)

Secondary Outcomes (1)

• symptoms score

  baseline (second visit) and after 4 weeks of treatment (third visit)

Interventions

budesonide and montelukast DRUG

budesonide and formoterol DRUG

montelukast DRUG

budesonide DRUG

placebo DRUG

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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%.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of Pediatrics and Allergy, Medical University of Lodz, Poland

Lodz, 93-513, Poland

Location

Related Publications (1)

• 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. 2007;20(6):691-700. doi: 10.1016/j.pupt.2006.08.003. Epub 2006 Sep 14.

  PMID: 17046300 RESULT

MeSH Terms

Conditions

Asthma; Motor Activity

Interventions

Budesonide; montelukast; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Officials

• Tomasz Grzelewski, MD, PhD

  Department of Pediatrics and Allergy, Medical University of Lodz, Poland

  PRINCIPAL INVESTIGATOR

• Iwona Stelmach, MD, PhD, Prof

  Department of Pediatrics and Allergy, Medical University of Lodz, Poland

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: June 21, 2007
• First Posted: June 22, 2007
• Study Start: July 1, 2003
• Study Completion: October 1, 2006
• Last Updated: June 28, 2007

Record last verified: 2007-06

Locations

PL (1)