NCT00770900

Brief Summary

Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic in patients with persistent asthma treated with montelukast

Trial Health

100
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for phase_4 asthma

Timeline
Completed

Started Sep 2008

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

September 1, 2008

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 9, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 10, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

December 20, 2010

Status Verified

January 1, 2010

Enrollment Period

1.2 years

First QC Date

October 9, 2008

Last Update Submit

December 17, 2010

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Verify if the quantitative parameters of the eosinophils activation and phagocyte system function show a predictive value for clinical response and prognostic.

    12 weeks

Study Arms (2)

Montelukast

EXPERIMENTAL

Asthmatic children and teenagers took montelukast daily.

Drug: montelukast sodium

Placebo

PLACEBO COMPARATOR

Placebo to montelukast tablet daily.

Drug: Comparator: placebo comparator

Interventions

montelukast sodiumDRUG

Asthmatic children and teenagers took montelukast daily for 12 weeks. Children aged 2-5 years took 4mg tablet of montelukast Children aged 6-15 years took 5mg tablet of montelukast Children \>15 years took 10mg tablet of montelukast

Also known as: Singulair
Montelukast
Comparator: placebo comparatorDRUG

Asthmatic children and teenagers took Placebo tablet daily for 12 weeks.

Placebo

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • Patients Between 2-18 Years With Persistent Asthma

You may not qualify if:

  • Patients \> 18 Years Old And \< 2 Years Old

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Asthma

Interventions

montelukast

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Study Officials

  • Medical Monitor

    Merck Sharp & Dohme LLC

    STUDY DIRECTOR

Study Design

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

Study Record Dates

First Submitted

October 9, 2008

First Posted

October 10, 2008

Study Start

September 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

December 20, 2010

Record last verified: 2010-01