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NCT00461812

A Single-Blind, Randomized, Positive-controlled Study to Compare Monotherapy With an Inhaled Corticosteroid (Mometasone) to Combination Therapy With an Inhaled Corticosteroid + a Long-Acting Bronchodilator (Advair) in Patients With Milder Persistent Asthma

Terminated Phase 4 Results posted Last updated 19 September 2017
What this trial tests

Phase 4 trial testing Mometasone in Asthma in 33 participants. Terminated before completion.

Timeline
1 April 2007
Primary endpoint
19 January 2010
19 January 2010

Quick facts

Lead sponsorJohns Hopkins University
PhasePhase 4
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment33
Start date1 April 2007
Primary completion19 January 2010
Estimated completion19 January 2010
Sites1 location across United States

Drugs / interventions tested

Conditions studied

Sponsor

Johns Hopkins University

Who can join

Adults 18 to 65, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

What's being measured

Primary outcomes are the specific endpoints the trial is designed to prove or disprove.

Sponsor's own description

The research hypothesis for the proposed study asks the question, can Asmanex® demonstrate comparable anti-inflammatory therapeutic efficacy to the combination product, Advair® in control of mild persistent asthma? The purpose is to demonstrate that the anti-inflammatory protection afforded by monotherapy with an inhaled steroid (Asmanex®) is comparable to combination therapy with Advair® 100/50, when measured by this standard methodology (methacholine bronchoprovocation) in subjects with mild persistent asthma.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

  1. Combination fixed-dose beta agonist and steroid inhaler as required for adults or children with mild asthma.
    Crossingham I, Turner S, Ramakrishnan S, Fries A, et al · · 2021 · cited 41× · PMID 33945639 · DOI 10.1002/14651858.cd013518.pub2

Verify or expand the search:

Other trials of Mometasone

Trials testing the same drug.

Other recruiting trials for Asthma

Currently open trials in the same condition.

Other Johns Hopkins University trials

Trials by the same sponsor.

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Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing