CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Nedocromil +3 moredrug
Likely dose
Nedocromil 4 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/NCT01061333
NCT01061333Phase 1Completed
CompareCT.gov

A Two-Part, Randomized, Placebo-Controlled, Crossover Trial to Evaluate the Differential Effects of Inhaled Nedocromil, Oral Montelukast, and Inhaled Mometasone on Markers of the Early Airway Response to Allergen in Asthmatics

Merck Sharp & Dohme LLC·interventional·Posted Feb 3, 2010·Updated Sep 4, 2015

In Brief

A Phase 1 clinical trial evaluating Nedocromil, Comparator: Montelukast, and 2 other interventions for Asthma. Completed, enrolled 16 participants.

Detailed Summary

This study will assess the Early Airway Response (EAR) associated change in forced expiratory volume in one second (FEV1) and plasma 9α-11ß-PGF2 ('9P') after single dose pretreatment of nedocromil, montelukast, and mometasone.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAsthma
Countries--
Collaborators--

Timeline

Phase 1CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
First PostedFeb 3, 2010
Enrollment StartJun 1, 2010
Primary CompletionFeb 1, 2011
Study CompletionMar 1, 2011
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 16.4 years ago

Interventions

Nedocromildrug

Nedocromil 4 mg, as metered dose inhaler 1 hour prior to allergen challenge

Comparator: Montelukastdrug

Montelukast single 10 mg tablet administered 2 hours prior to allergen challenge

Comparator: Mometasonedrug

Mometasone furoate 400 mcg by twisthaler, administered 2 hours prior to allergen challenge

Placebodrug

Mometasone placebo twisthaler, Nedocromil placebo metered dose inhaler, Montelukast placebo tablet