Ignite Creation Date:
2024-05-05 @ 4:47 PM
Last Modification Date:
2024-10-26 @ 9:24 AM
Study NCT ID:
NCT00311051
Status:
WITHDRAWN
Last Update Posted:
2012-04-16
First Post:
2006-04-01
Brief Title:
RamatrobanMontelukast Versus MontelukastPlacebo on the Early Allergic Reaction in Asthma Sensitive to House Dust Mite
Sponsor:
Research Center Borstel
Organization:
Research Center Borstel
Study Overview
Official Title:
A Randomized Double-blind and Placebo-controlled Study to the Influence of RamatrobanMontelukast Versus MontelukastPlacebo on the Early Allergic Reaction in Patients With Mild to Moderate Atopic Asthma House Dust Mite
Status:
WITHDRAWN
Status Verified Date:
2012-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to examine wether the combination of RamatrobanMontelukast 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
Detailed Description:
In the early allergic response in asthma allergens connect to IgE on mast cells and basophile granulocytes For that there are 3 main pathways in activation
Besides quick liberation of Histamine and induction of cytokines there is a liberation of mediators from the arachidonate metabolism In addition to Histamine there are especially Prostaglandin PGD2 Leukotriene LTC4 and also Thromboxane A2 for the classic symptoms of the early allergic reaction responsible All of those mediators have potent bronchoconstrictive activity
Prostaglandin D2 and Thromboxane A2 work on Thromboxane receptors LTC4 links to Cys-LT-receptors
According to an in-vitro-model of the early allergic reaction in human precision-cut lung slices with passive specific sensitization against grass-pollen it has been shown that the early allergic response can only be suppressed partly by giving Antihistamines Leukotriene receptor antagonists or Thromboxane receptor antagonist all on its own It goes in consent with clinical findings that all of these drugs alone have just an insufficient activity on asthma
In the described human in-vitro-model the combination of Thromboxane receptor antagonist with Leukotriene receptor antagonist Montelukast blocked the early response in asthma completely
These findings are the rationale for our study because so far there is no clinical data about the effect of the combination of Leukotriene receptor antagonist Montelukast with Thromboxane receptor antagonist
The drug Montelukast is a Leukotriene receptor antagonist which is known for the treatment of mild to moderate asthma in Germany According to the GINA-Guidelines Montelukast is given in addition to steroids and β-mimetics in asthma severity grade II and III
The drug Ramatroban is a Thromboxane A2 receptor antagonist which is in Japan allowed for the treatment of allergic rhinitis It also has an anti-asthmatic effect because it blocks bronchoconstriction hyperresponsiveness of the airways and infiltration of inflammation cells Furthermore it has positive effects on allergic rhinitis by blocking the permeability of capillaries blocking the nasal hyperresponsiveness and the infiltration of the mucosa by eosinophils
During the studies Ramatroban has proved to be a save drug for the indication allergic rhinitis and also allergic asthma In contrast to sufficient effectiveness in the indication allergic rhinitis it has been said that there is just insufficient effectiveness in the indication asthma
About the combination of Ramatroban and Montelukast exists no clinical data so the study at hand examines the effect of RamatrobanMontelukast versus MontelukastPlacebo on the early allergic reaction in patients with mild to moderate atopic asthma GINA I and II sensitive to house dust mites in a specific inhalative provocation
Besides quick liberation of Histamine and induction of cytokines there is a liberation of mediators from the arachidonate metabolism In addition to Histamine there are especially Prostaglandin PGD2 Leukotriene LTC4 and also Thromboxane A2 for the classic symptoms of the early allergic reaction responsible All of those mediators have potent bronchoconstrictive activity
Prostaglandin D2 and Thromboxane A2 work on Thromboxane receptors LTC4 links to Cys-LT-receptors
According to an in-vitro-model of the early allergic reaction in human precision-cut lung slices with passive specific sensitization against grass-pollen it has been shown that the early allergic response can only be suppressed partly by giving Antihistamines Leukotriene receptor antagonists or Thromboxane receptor antagonist all on its own It goes in consent with clinical findings that all of these drugs alone have just an insufficient activity on asthma
In the described human in-vitro-model the combination of Thromboxane receptor antagonist with Leukotriene receptor antagonist Montelukast blocked the early response in asthma completely
These findings are the rationale for our study because so far there is no clinical data about the effect of the combination of Leukotriene receptor antagonist Montelukast with Thromboxane receptor antagonist
The drug Montelukast is a Leukotriene receptor antagonist which is known for the treatment of mild to moderate asthma in Germany According to the GINA-Guidelines Montelukast is given in addition to steroids and β-mimetics in asthma severity grade II and III
The drug Ramatroban is a Thromboxane A2 receptor antagonist which is in Japan allowed for the treatment of allergic rhinitis It also has an anti-asthmatic effect because it blocks bronchoconstriction hyperresponsiveness of the airways and infiltration of inflammation cells Furthermore it has positive effects on allergic rhinitis by blocking the permeability of capillaries blocking the nasal hyperresponsiveness and the infiltration of the mucosa by eosinophils
During the studies Ramatroban has proved to be a save drug for the indication allergic rhinitis and also allergic asthma In contrast to sufficient effectiveness in the indication allergic rhinitis it has been said that there is just insufficient effectiveness in the indication asthma
About the combination of Ramatroban and Montelukast exists no clinical data so the study at hand examines the effect of RamatrobanMontelukast versus MontelukastPlacebo on the early allergic reaction in patients with mild to moderate atopic asthma GINA I and II sensitive to house dust mites in a specific inhalative provocation
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| Bundesinstitut BfArM | None | None | None |
| 4022229 | None | None | None |