NCT00488176

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
116

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Apr 2007

Longer than P75 for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2007

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

June 19, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 20, 2007

Completed
6.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2013

Completed
Last Updated

February 7, 2013

Status Verified

February 1, 2013

Enrollment Period

6.6 years

First QC Date

June 19, 2007

Last Update Submit

February 6, 2013

Conditions

Seasonal Allergic Rhinitis

Keywords

seasonal allergic rhinitischildrenmontelukastcetirizine

Outcome Measures

Primary Outcomes (1)

  • exhaled nitric oxide concentration

    baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)

Secondary Outcomes (1)

  • symptoms score (based on PAQLQ), bronchial hyperresponsiveness with methacholine, spirometry, PEFR measurements

    baseline (first visit), after 4 weeks (second visit) and after 6 weeks from second visit (third visit)

Study Arms (4)

1

ACTIVE COMPARATOR

monteluksat sodium

Drug: montelukast

2

ACTIVE COMPARATOR

cetirizine

Drug: cetirizine

3

ACTIVE COMPARATOR

montelukast sodium and cetirizine

Drug: montelukast and cetirizine

4

PLACEBO COMPARATOR

placebo

Drug: placebo

Interventions

montelukastDRUG

montelukast sodium

Also known as: montelukast sodium
1
cetirizineDRUG

cetirizine

2
montelukast and cetirizineDRUG

montelukast and cetirizine

3
placeboDRUG

placebo

4

Eligibility Criteria

Age6 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Lodz, 93-513, Poland

RECRUITING

MeSH Terms

Conditions

Rhinitis, Allergic, Seasonal

Interventions

montelukastCetirizine

Condition Hierarchy (Ancestors)

Rhinitis, AllergicRhinitisNose DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityOtorhinolaryngologic DiseasesHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

HydroxyzinePiperazinesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Study Officials

  • Violetta Ścibiorek, MD

    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

Central Study Contacts

Violetta Ścibiorek, MD

CONTACT

00 48 42 6895972alergol@kopernik.lodz.pl

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Professor

Study Record Dates

First Submitted

June 19, 2007

First Posted

June 20, 2007

Study Start

April 1, 2007

Primary Completion

November 1, 2013

Study Completion

December 1, 2013

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

PL(1)