CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 15 enrolled
Drug / intervention
montelukastdrug
Likely dose
montelukast 10 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00947453
NCT00947453Phase 2Completed

The Effect of Montelukast Therapy on mRNA Profile of Matrix Metalloproteinases and Their Inhibitors in the Sputum of Patients With Asthma

University of East Anglia·interventional·Posted Jul 28, 2009·Updated Aug 23, 2012

In Brief

A Phase 2 clinical trial evaluating montelukast for Asthma. Completed, enrolled 15 participants across 1 site.

Detailed Summary

Matrix metalloproteinases (MMPs) are a group of 24 zinc containing enzymes in man. These enzymes were originally described as cleaving extracellular matrix (ECM) substrates with a predominant role in ECM homeostasis, but it is now clear that they have much wider functionality. An imbalance between MMP activity and that of their inhibitors (tissue inhibitors of metalloproteinases, TIMPs) is considered to play a critical role in the synthesis or degradation of the extracellular matrix of the airway architecture which results in fixed airflow obstruction in both asthma and chronic obstructive pulmonary disease (COPD). Using quantitative real time polymerase chain reaction (RT-PCR) the investigators have identified a difference between the level of steady state mRNA for MMP-9, MMP-14 and MMP-2 in 2 patients with asthma compared to 4 healthy controls using our method. However the investigators require further refinement of the process in order to optimise RNA quality and to evaluate the effect of montelukast across the entire family of MMPs and their inhibitors (TIMPs).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
CountriesUnited Kingdom

Timeline

Phase 2CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedJul 28, 2009
Enrollment StartJul 1, 2009
Primary CompletionDec 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 16.9 years ago

Interventions

montelukastdrug

montelukast 10 mg once daily for 8 weeks