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

Primary Purpose

Asthma

Status
Completed
Phase
Phase 4
Locations
Poland
Study Type
Interventional
Intervention
budesonide and montelukast
budesonide and formoterol
montelukast
budesonide
placebo
Sponsored by
Medical University of Lodz
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Asthma focused on measuring Asthma, Children, Exercise, Pulmonary Function, Budesonide, Montelukast, Formoterol

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Outcomes

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

Secondary Outcome Measures

symptoms score

Full Information

First Posted
June 21, 2007
Last Updated
June 27, 2007
Sponsor
Medical University of Lodz
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1. Study Identification

Unique Protocol Identification Number
NCT00490243
Brief Title
Effect of Different Anti-Asthmatic Treatments on Lung Function and on Exercise-Induced Bronchoconstriction in Children With Asthma
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2007
Overall Recruitment Status
Completed
Study Start Date
July 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
October 2006 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Medical University of Lodz

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Asthma
Keywords
Asthma, Children, Exercise, Pulmonary Function, Budesonide, Montelukast, Formoterol

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Double
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
budesonide and montelukast
Intervention Type
Drug
Intervention Name(s)
budesonide and formoterol
Intervention Type
Drug
Intervention Name(s)
montelukast
Intervention Type
Drug
Intervention Name(s)
budesonide
Intervention Type
Drug
Intervention Name(s)
placebo
Primary Outcome Measure Information:
Title
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 Measure Information:
Title
symptoms score
Time Frame
baseline (second visit) and after 4 weeks of treatment (third visit)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tomasz Grzelewski, MD, PhD
Organizational Affiliation
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Iwona Stelmach, MD, PhD, Prof
Organizational Affiliation
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
Official's Role
Study Chair
Facility Information:
Facility Name
Department of Pediatrics and Allergy, Medical University of Lodz, Poland
City
Lodz
ZIP/Postal Code
93-513
Country
Poland

12. IPD Sharing Statement

Citations:
PubMed Identifier
17046300
Citation
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.
Results Reference
result

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

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