NCT00311051

Brief Summary

The purpose of this study is to examine wether the combination of Ramatroban/Montelukast is as effective as Montelukast alone in patients with mild to moderate atopic asthma (GINA I and II) sensitive to house dust mite. The test is performed by a specific inhalative provocation.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Apr 2005

Typical duration for phase_2 asthma

Geographic Reach
1 country

1 active site

Status
withdrawn

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

April 1, 2005

Completed
1 year until next milestone

First Submitted

Initial submission to the registry

April 1, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 5, 2006

Completed
12 months until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2007

Completed
Last Updated

April 16, 2012

Status Verified

April 1, 2012

First QC Date

April 1, 2006

Last Update Submit

April 13, 2012

Conditions

Asthma

Keywords

AsthmaAllergenshouse dust mitesRamatrobanMontelukastBronchial Provocation Tests

Outcome Measures

Primary Outcomes (2)

  • Lung function by spirometry

  • Allergen concentration for specific bronchoprovocation

Secondary Outcomes (1)

  • Blood level of thromboxane and leukotriene metabolite

Interventions

ramatrobanDRUG
montelukastDRUG

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Atopic (house dust mite) asthma
  • Severity GINA one and two

You may not qualify if:

  • No reaction in specific bronchial provocation test
  • Other kind of clinical relevant atopic reaction

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Research Center Borstel

Borstel, 23845, Germany

Location

Related Publications (1)

  • Wohlsen A, Martin C, Vollmer E, Branscheid D, Magnussen H, Becker WM, Lepp U, Uhlig S. The early allergic response in small airways of human precision-cut lung slices. Eur Respir J. 2003 Jun;21(6):1024-32. doi: 10.1183/09031936.03.00027502.

    PMID: 12797499BACKGROUND

MeSH Terms

Conditions

Asthma

Interventions

ramatrobanmontelukast

Condition Hierarchy (Ancestors)

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

Study Officials

  • Peter Zabel, Prof.

    Research Center Borstel

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 1, 2006

First Posted

April 5, 2006

Study Start

April 1, 2005

Study Completion

April 1, 2007

Last Updated

April 16, 2012

Record last verified: 2012-04

Locations

DE(1)