LOS: Leukotriene Receptor Antagonists or Steroids in Pre-School Asthma

• Sponsor: Johann Wolfgang Goethe University Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT00543686
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arms: 2
• Duration (Months): 18.1
• Patients Per Site Per Month: 5.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Asthma	Drug: Montelukast; Drug: Fluticasone	Phase 2

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Aug 1, 2007
• Actual Primary Completion Date: Jan 1, 2009
• Actual Study Completion Date: Feb 1, 2009

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 1 Montelukast	Drug: Montelukast; Intake of Montelukast
Active Comparator: 2 Fluticasone	Drug: Fluticasone; Intake of Fluticasone

Outcome Measures

Primary Outcome Measures

1. 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

1. 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 []

Eligibility Criteria

Criteria

• Ages Eligible for Study: 4 Years to 6 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Goethe University, Department of Pulmonology	Frankfurt	Hessen	Germany	60590

Sponsors and Collaborators

• Johann Wolfgang Goethe University Hospital

Investigators

• Principal Investigator: Stefan Zielen, Prof. Dr., Johann Wolfgang Goethe-University Frankfurt, Zentrum für Kinderheilkunde I, Haus 32, Abt. Pneumologie

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• ClinicalTrials.gov Identifier: NCT00543686
• Other Study ID Numbers: 165/07/FFM
• First Posted: Oct 15, 2007
• Last Update Posted: Feb 4, 2009
• Last Verified: Feb 1, 2009

• Keywords provided by , ,: Pre-School Asthma; Responder Profiles; Fluticasone; Montelukast; Leukotriene; Children with Pre-School Asthma
• Additional relevant MeSH terms: Asthma; Fluticasone; Montelukast

Study Results

No Results Posted as of Feb 4, 2009