Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

Asthma Clinical Trial

— 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00543686
• Other study ID #: 165/07/FFM
• Status: Completed
• Phase: Phase 2
• First received: October 11, 2007
• Last updated: February 3, 2009
• Start date: August 2007
• Est. completion date: February 2009

Study information

• Verified date: February 2009
• Source: Johann Wolfgang Goethe University Hospitals
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: February 2009
• Est. primary completion date: January 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 4 Years to 6 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• Montelukast
Intake of Montelukast
• Fluticasone
Intake of Fluticasone

Locations

Country	Name	City	State
Germany	Goethe University, Department of Pulmonology	Frankfurt	Hessen

Sponsors (1)

Lead Sponsor	Collaborator
Johann Wolfgang Goethe University Hospitals

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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