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Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis

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ClinicalTrials.gov Identifier: NCT00488176
Recruitment Status : Unknown
Verified February 2013 by Iwona Stelmach, Medical University of Lodz.
Recruitment status was:  Recruiting
First Posted : June 20, 2007
Last Update Posted : February 7, 2013
Sponsor:
Information provided by (Responsible Party):
Iwona Stelmach, Medical University of Lodz

Tracking Information
First Submitted Date  ICMJE June 19, 2007
First Posted Date  ICMJE June 20, 2007
Last Update Posted Date February 7, 2013
Study Start Date  ICMJE April 2007
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 19, 2007)
exhaled nitric oxide concentration [ Time Frame: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit) ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 19, 2007)
symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements [ Time Frame: baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit) ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation in Children With Allergic Rhinitis
Official Title  ICMJE Comparison of the Effect of Montelukast and Cetirizine on Allergic Inflammation Measured by Exhaled Nitric Oxide Concentration in Children With Seasonal Allergic Rhinitis
Brief Summary The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.
Detailed Description

During the pollen season children with seasonal allergic rhinitis without concomitant asthma are at risk of having allergic inflammation in the lower respiratory tract. About 60% of children with seasonal allergic rhinitis present bronchial hyperresponsiveness and signs and symptoms of asthma.

The aim of this study is to compare the effect of montelukast and cetirizine on allergic inflammation measured by exhaled nitric oxide concentration in children with seasonal allergic rhinitis.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Seasonal Allergic Rhinitis
Intervention  ICMJE
  • Drug: montelukast
    montelukast sodium
    Other Name: montelukast sodium
  • Drug: cetirizine
    cetirizine
  • Drug: montelukast and cetirizine
    montelukast and cetirizine
  • Drug: placebo
    placebo
Study Arms  ICMJE
  • Active Comparator: 1
    monteluksat sodium
    Intervention: Drug: montelukast
  • Active Comparator: 2
    cetirizine
    Intervention: Drug: cetirizine
  • Active Comparator: 3
    montelukast sodium and cetirizine
    Intervention: Drug: montelukast and cetirizine
  • Placebo Comparator: 4
    placebo
    Intervention: Drug: placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: June 19, 2007)
116
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2013
Estimated Primary Completion Date November 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • clinical symptoms of seasonal allergic rhinitis during last two seasons, moderate and severe according to ARIA guidelines

Exclusion Criteria:

  • diagnosis of bronchial asthma
  • allergy to perennial allergens
  • specific immunotherapy
  • other chronic diseases
  • tobacco smoking
  • acute respiratory tract infection
  • excluded drugs: inhaled and systemic glucocorticosteroids
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 6 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Poland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00488176
Other Study ID Numbers  ICMJE RNN/94/07KE
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Iwona Stelmach, Medical University of Lodz
Original Responsible Party Not Provided
Current Study Sponsor  ICMJE Medical University of Lodz
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Violetta Ścibiorek, MD 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
PRS Account Medical University of Lodz
Verification Date February 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP