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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00935415
Other study ID # PPDD1962
Secondary ID
Status Completed
Phase Phase 4
First received July 7, 2009
Last updated July 8, 2009
Start date January 2007
Est. completion date August 2008

Study information

Verified date July 2009
Source Universita di Verona
Contact n/a
Is FDA regulated No
Health authority Italy: Ethics Committee
Study type Interventional

Clinical Trial 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.


Description:

Within few days after a baseline exercise challenge, children was randomized to a double blind, placebo-controlled, three day doses, crossover study design. In practice each eligible patient was randomized by a computer-generated schedule to receive in sequence double-blind treatments with placebo or MNT (5 mg). Patients in sequence 1 received MNT, then crossed over to matching placebo; vice versa the case was for patients in sequence 2. Placebo and active treatments were separated by a 7-10 day wash-out period. Each child was assigned to one out of seven groups in order to perform the exercise challenge at different time intervals from drug administration which occurred always at 8.00 A.M. On day one the challenge was performed in the different groups 1, 2, 3, 4, 5, 6, and 8 hours after drug administration, respectively. Then treatment was continued as a single day dose for three consecutive days and a third challenge was then performed at the same time of the day.


Recruitment information / eligibility

Status Completed
Enrollment 69
Est. completion date August 2008
Est. primary completion date August 2008
Accepts healthy volunteers No
Gender Both
Age group 6 Years to 14 Years
Eligibility Inclusion Criteria:

- children with exercise-induced asthma

Exclusion Criteria:

- viral infections

- montelukast treatment

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
Montelukast
Montelukast 5 mg
Placebo
capsules of matching placebo

Locations

Country Name City State
Italy Pediatric Dept Hospital of Bolzano Bolzano

Sponsors (1)

Lead Sponsor Collaborator
Universita di Verona

Country where clinical trial is conducted

Italy, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary clinical protection at the first and at the third day of single day drug administration No
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