NCT00935415

Brief Summary

The aim of this study is to verify MNT time of onset of protection against EIB in asthmatic children by evaluating different time intervals between dosing and challenge, after a single-dose and after three days of once a day MNT administration.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
69

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Jan 2007

Geographic Reach
1 country

1 active site

Status
completed

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

January 1, 2007

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2008

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 7, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 9, 2009

Completed
Last Updated

July 9, 2009

Status Verified

July 1, 2009

Enrollment Period

1.6 years

First QC Date

July 7, 2009

Last Update Submit

July 8, 2009

Conditions

Exercise-Induced AsthmaAsthma

Keywords

asthmaexercise-induced bronchoconstrictionmontelukastclinical protectionchildrentime effect

Outcome Measures

Primary Outcomes (1)

  • maximal percentage fall in FEV1 after exercise test from the baseline value

    at the first and at the third day of single day drug administration

Secondary Outcomes (1)

  • clinical protection

    at the first and at the third day of single day drug administration

Study Arms (2)

Montelukast

ACTIVE COMPARATOR

capsules prepared in blindness

Drug: Montelukast

Placebo

PLACEBO COMPARATOR

matched placebo

Drug: Placebo

Interventions

MontelukastDRUG

Montelukast 5 mg

Also known as: Singulair
Montelukast
PlaceboDRUG

capsules of matching placebo

Placebo

Eligibility Criteria

Age6 Years - 14 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

  • children with exercise-induced asthma

You may not qualify if:

  • viral infections
  • montelukast treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Pediatric Dept Hospital of Bolzano

Bolzano, Italy

Location

MeSH Terms

Conditions

Asthma, Exercise-InducedAsthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesRespiratory HypersensitivityExercise-Induced AllergiesHypersensitivity, ImmediateHypersensitivityImmune System DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • Attilio Boner, MD

    Universita di Verona

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 7, 2009

First Posted

July 9, 2009

Study Start

January 1, 2007

Primary Completion

August 1, 2008

Study Completion

August 1, 2008

Last Updated

July 9, 2009

Record last verified: 2009-07

Locations

IT(1)