Last reviewed · How we verify
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
Phase 4 trial testing Mometasone in Asthma in 33 participants. Terminated before completion.
19 January 2010
Quick facts
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | Phase 4 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 33 |
| Start date | 1 April 2007 |
| Primary completion | 19 January 2010 |
| Estimated completion | 19 January 2010 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Mometasone — full drug profile →
- Advair — full drug profile →
Conditions studied
- Asthma — all drugs for Asthma →
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.
-
Efficacy as Assessed my Pulmonary Function Tests
Time frame: change from baseline to study completion
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):
-
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:
- PubMed search for NCT00461812
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of Mometasone
Trials testing the same drug.
- NCT05311475 — Prospective, Randomized, Multinational, Multicenter, Double-blind, Placebo and Active Controlled Trial in 4 Parallel-gro · Phase 3 · completed
- NCT03758950 — Inhaled Mometasone to Promote Reduction in Vasoocclusive Events 2 · Phase 2 · completed
- NCT00783237 — Onset of Effect of Mometasone Nasal Spray in Induced Allergic Rhinitis (Study P03431) · Phase 4 · completed
- NCT00070707 — Nasonex Compared With Placebo in Participants With Seasonal Allergic Rhinitis (SAR) and Concomitant Asthma (P03280) · Phase 4 · completed
- NCT00763529 — Elocon vs Fluticasone in Localized Psoriasis (P03197) · Phase 4 · completed
Other recruiting trials for Asthma
Currently open trials in the same condition.
- NCT07525375 — A Phase II Study to Investigate Lung Function With 2 Different Doses of Inhaled Glycopyrronium Taken With BFF Compared t · Phase 2 · recruiting
- NCT07536256 — Community Connections Through Native Hawaiian Cultural Values to Strengthen Youth Resilience, Health, and Well-Being · NA · recruiting
- NCT07556159 — A Study Evaluating Disease Characteristics and Outcomes in Participants With Asthma in Routine Clinical Practice · recruiting
- NCT07282886 — VENTURI (VENTilation Using Respiratory Imaging) · Phase 2 · recruiting
- NCT07433569 — A Study to Investigate How Budesonide and Formoterol Move Through the Body (Pharmacokinetics) When Delivered With Differ · Phase 1 · recruiting
Other Johns Hopkins University trials
Trials by the same sponsor.
- NCT06236542 — Tracheostomy Robotics and Cutting-edge Health Education for Airway Safety · NA · not yet recruiting
- NCT07532252 — Daridorexant for Alcohol Use Disorder · Phase 2 · not yet recruiting
- NCT06687655 — Impact of Exogenous Ketones on Sleep Apnea · Phase 1, PHASE2 · not yet recruiting
- NCT07079111 — 3D Printed Occlusal Splints for Intraoperative Use · NA · not yet recruiting
- NCT02998502 — The Use of a FDA Cleared, Drug-free, Breathing System for Anxiety and Panic Disorders in Children and Teens · NA · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT00461812 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Johns Hopkins University
- Last refreshed: 19 September 2017
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00461812.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing