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OpenTrials
Completed

NCT Number: NCT00675285

Effects of Montelukast in Children With Asthma

Leukotriene receptor antagonists (LTRAs) reduce fractional exhaled nitric oxide (FENO) concentrations in children with asthma, but the effect of LTRA withdrawal on FENO and lung function is unknown. We will aim to study the effect of treatment and withdrawal of montelukast, a LTRA, on airway inflammation as reflected by FENO and lung function in children with asthma.

A double-blind, randomized, placebo controlled, parallel group study will be undertaken in 18 atopic children with mild persistent asthma who will be treated with oral montelukast (5 mg/day for 4 weeks) and 18 atopic children with mild persistent asthma who will receive matching placebo.

A follow-up visit will be performed 2 weeks after montelukast or placebo withdrawal.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

6 year–14 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Catholic University of the Sacred Heart

Rome, 00168, Italy

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Children 6 to 14 yrs old, step 1 and step 2 GINA (Global INitiative for Asthma) guidelines
  • exhaled nitric oxide (NO) >20 PPB at visit 2
  • symptoms more often than twice a day, FEV1 equal or higher than 80% of predicted value and reversibility equal or higher than 12% to salbutamol, or a positive provocation test with methacholine, or exercise
  • no regular medication, inhaled short-acting beta-2 agonists for symptom relief

Exclusion criteria

  • Patient is hospitalized
  • Patient has FEV1 < 80% predicted on visit 1
  • Patient has 2 or more nighttime awakenings for asthma per week or pef variability 30% or more
  • upper respiratory infection in the previous 3 weeks
  • treatment with glucocorticoids or LTRAs in the previous 4 weeks
  • treatment with inhaled glucocorticoids for more than 4 weeks in the previous year

Treatment and study plan

montelukast sodium

Drug

one tablet 5 mg once/day for 4 weeks

Placebo

Drug

one tablet 5 mg once/day for 4 weeks

Primary outcomes

  1. post-treatment fractional exhaled nitric oxide

Secondary outcomes

  1. fractional exhaled nitric oxide 2 weeks after montelukast withdrawal

  2. post-treatment FEV1

  3. post-treatment FVC

  4. post-treatment FEV1/FVC

  5. post-treatment FEF25%-75%

  6. FEV1 2 weeks after montelukast withdrawal

  7. FVC 2 weeks after montelukast withdrawal

  8. FEV1/FVC 2 weeks after montelukast withdrawal

  9. FEF25%-75% 2 weeks after montelukast withdrawal

  10. asthma exacerbation rate

Sponsors and collaborators

Lead sponsor

Catholic University of the Sacred Heart

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Effects of Oral Montelukast on Airway Inflammation in Children With Mild Asthma

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
May 9, 2008
Registry last updated
May 9, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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