NCT01266772

Brief Summary

This is 9 month, placebo-controlled, double blind, randomised trial using the oral leucotrienes receptor antagonist montelukast (5 mg) in 160 children with mild and moderate asthma age 6-14 year old, sensitive to house dust mite. There are two study groups: montelukast group 80 patients and placebo group 80 patients. All patients will receive budesonide in dose sufficient to control asthma symptoms and short-acting beta agonist as needed. Medication used in the study: montelukast 5mg, budesonide. There are 7 doctor's visits - one initial visit (June) and 6 follow-up visits. First visit is on the first day of asthma symptom and each follow-up visit is every 6 weeks. Children with full asthma control (as measured by exhaled NO) had administered 100 mcg lower dose of budesonide and children with not fully control asthma had administered 100 mcg higher dose of budesonide.

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
160

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Jan 2011

Typical duration for phase_3

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

First Submitted

Initial submission to the registry

December 23, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 24, 2010

Completed
8 days until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2013

Completed
Same day 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

2.9 years

First QC Date

December 23, 2010

Last Update Submit

February 6, 2013

Conditions

Bronchial Asthma

Keywords

asthma; children; montelukast; treatment; exacerbation

Outcome Measures

Primary Outcomes (1)

  • Steroid dose,medium steroid dose/day,number of asthma exacerbations,maximum fall of FEV1 in exercise, asthma symptoms, lung function, number of patients with positive airway hyperresponsiveness

    * steroid doses sufficient to control asthma symptoms * medium steroid dose/day times 6 month * number of asthma exacerbations in 9 month period * maximum fall of FEV1 in exercise induced bronchoconstriction test * asthma symptoms scale and lung function * number of patients with positive airway hyperresponsiveness test

    9 months

Study Arms (2)

montelukast group

ACTIVE COMPARATOR

Children with asthma treated with montelukast and budesonide.

Drug: Montelukast sodium.

Placebo group

PLACEBO COMPARATOR

Children with asthma treated with placebo tablet and budesonide.

Drug: Placebo tablet and budesonide

Interventions

Montelukast sodium.DRUG

Children with asthma treated with montelukast and budesonide.

Also known as: Montelukast and Budesonide
montelukast group
Placebo tablet and budesonideDRUG

Children with asthma treated with placebo tablet and budesonide.

Also known as: Placebo tablet and Budesonide.
Placebo group

Eligibility Criteria

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

You may qualify if:

  • Children with bronchial asthma

You may not qualify if:

  • All other serious diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital

Lodz, 93-513, Poland

RECRUITING

Related Publications (1)

  • Stelmach I, Ozarek-Hanc A, Zaczeniuk M, Stelmach W, Smejda K, Majak P, Jerzynska J, Anna J. Do children with stable asthma benefit from addition of montelukast to inhaled corticosteroids: randomized, placebo controlled trial. Pulm Pharmacol Ther. 2015 Apr;31:42-8. doi: 10.1016/j.pupt.2015.01.004. Epub 2015 Jan 30.

    PMID: 25640020DERIVED

MeSH Terms

Conditions

Asthma

Interventions

montelukastBudesonide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

PregnenedionesPregnenesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Agata Ożarek-Hanc, MD

    Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland.

    PRINCIPAL INVESTIGATOR

  • Iwona Stelmach, Prof.

    Department of Pediatrics and Allergy, Medical University of Lodz, N. Copernicus Hospital, Lodz, Poland

    STUDY CHAIR

Central Study Contacts

Agata Ożarek-Hanc, MD

CONTACT

0048426895972alergol@kopernik.lodz.pl

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, PhD, Prof

Study Record Dates

First Submitted

December 23, 2010

First Posted

December 24, 2010

Study Start

January 1, 2011

Primary Completion

December 1, 2013

Study Completion

December 1, 2013

Last Updated

February 7, 2013

Record last verified: 2013-02

Locations

PL(1)