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Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma (LOS)

Primary Purpose

Asthma

Status

Completed

Phase

Phase 2

Locations

Germany

Study Type

Interventional

Intervention

Montelukast

Fluticasone

About this trial

This is an interventional treatment trial for Asthma focused on measuring Pre-School Asthma, Responder Profiles, Fluticasone, Montelukast, Leukotriene, Children with Pre-School Asthma

Eligibility Criteria

4 Years - 6 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Male or female patients age 4 -6 years
Diagnosis of mild intermittent bronchial asthma (Step I-II) in the past 6 - 12 months as stated by the investigator:
Use of inhaled beta-2-agonists < 1/week (max 3 puff /d)
Exacerbation-free interval > 4 weeks prior to visit 1
The written informed consent of parents after received written and oral information about the aim, purpose and risks of the study must be present

Exclusion Criteria:

Asthma severity ≥ Step 2
Severe concomitant diseases
Suspected non-compliance
age below 4 and age above 7 years
last study participation < 30 days

Sites / Locations

Goethe University, Department of Pulmonology

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Arm Description

Montelukast

Fluticasone

Outcomes

Primary Outcome Measures

The primary efficacy variable is the number of responders with a very good asthma symptom control defined as requiring no rapid acting beta agonist (RABA) between the 2. and 6th week of intervention (end of trial)

Secondary Outcome Measures

the number of patients requiring at least five times RABA between the 2. and 6th week, the number of patients with an increase of FEV1 7.5%, the symptom score, symptom free days, rescue medication, presence of allergy RAST > 2, concentration of eNO, PD20

Full Information

NCT ID

NCT00543686

First Posted

October 11, 2007

Last Updated

February 3, 2009

Sponsor

Johann Wolfgang Goethe University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT00543686

Brief Title

Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

Acronym

LOS

Official Title

A Randomised Controlled Open-Label Phase IV Mono Centre Study to Compare the Response Profiles of Montelukast Versus Fluticasone in Children With Pre-School Asthma

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Completed

Study Start Date

August 2007 (undefined)

Primary Completion Date

January 2009 (Actual)

Study Completion Date

February 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Johann Wolfgang Goethe University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Explorative comparison of montelukast with inhaled steroids (fluticasone) to estimate responder profiles, in terms of symptom scores, rescue medication, increase of FEV1, in correlation to presence of allergy, bronchial hyperreactivity (PD20), exhaled NO, excretion of leukotrienes, response to RABA and laboratory parameters in patients with pre-school asthma i.e. asthma phenotypes.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Asthma

Keywords

Pre-School Asthma, Responder Profiles, Fluticasone, Montelukast, Leukotriene, Children with Pre-School Asthma

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Montelukast

Arm Title

Arm Type

Active Comparator

Arm Description

Fluticasone

Intervention Type

Drug

Intervention Name(s)

Montelukast

Intervention Description

Intake of Montelukast

Intervention Type

Drug

Intervention Name(s)

Fluticasone

Intervention Description

Intake of Fluticasone

Primary Outcome Measure Information:

Title

Secondary Outcome Measure Information:

Title

10. Eligibility

Sex

All

Minimum Age & Unit of Time

4 Years

Maximum Age & Unit of Time

6 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Male or female patients age 4 -6 years Diagnosis of mild intermittent bronchial asthma (Step I-II) in the past 6 - 12 months as stated by the investigator: Use of inhaled beta-2-agonists < 1/week (max 3 puff /d) Exacerbation-free interval > 4 weeks prior to visit 1 The written informed consent of parents after received written and oral information about the aim, purpose and risks of the study must be present Exclusion Criteria: Asthma severity ≥ Step 2 Severe concomitant diseases Suspected non-compliance age below 4 and age above 7 years last study participation < 30 days

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Stefan Zielen, Prof. Dr.

Organizational Affiliation

Johann Wolfgang Goethe-University Frankfurt, Zentrum für Kinderheilkunde I, Haus 32, Abt. Pneumologie

Official's Role

Principal Investigator

Facility Information:

Facility Name

Goethe University, Department of Pulmonology

City

Frankfurt

State/Province

Hessen

ZIP/Postal Code

60590

Country

Germany

12. IPD Sharing Statement

Citations:

PubMed Identifier

20001651

Citation

Zielen S, Christmann M, Kloska M, Dogan-Yildiz G, Lieb A, Rosewich M, Schubert R, Rose MA, Schulze J. Predicting short term response to anti-inflammatory therapy in young children with asthma. Curr Med Res Opin. 2010 Feb;26(2):483-92. doi: 10.1185/03007990903485148.

Results Reference

derived

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Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

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