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NCT02061202 · ClinicalTrials.gov registry record · Phase 2

Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease

A Phase 2 study of Sickle Cell Disease, sponsored by Jeffrey Glassberg.

Completed
Registry status
Phase 2
Development phase
54
Enrollment target
1
Study location

NCT02061202 is a Phase 2 study of Sickle Cell Disease that has completed, run by Jeffrey Glassberg. The registered enrollment target is 54 participants, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (82% lower). The trial reports 1 study location across 1 state.

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The verdict

NCT02061202, a Phase 2 study of Sickle Cell Disease, has completed, sponsored by Jeffrey Glassberg.

COMPLETED
Registry status
Phase 2
Development phase
54 participants
Enrollment target
1
Study location

Study Summary

The proposed research is designed to test the global hypothesis that inhaled corticosteroids (ICS), a therapy developed to treat asthma, will prevent vasoocclusive painful episodes in adults with Sickle Cell Disease (SCD) who wheeze, but do not meet criteria for a diagnosis of asthma. The specific aims of this proposal are 1) Conduct a feasibility study - a randomized controlled trial of ICS for adults with SCD who do not meet criteria for a diagnosis of asthma but report recurrent cough or wheezing, 2) Measure the effects of ICS on biological correlates of pulmonary inflammation (as determined by exhaled nitric oxide) and vascular injury (as determined by sVCAM) in SCD, and 3) Compare properties of traditional and Bayesian adaptive clinical trial design for therapeutic trials in SCD in preparation for designing a definitive trial of ICS. These aims have the potential to 1) change the standard of care for individuals with SCD and recurrent cough or wheeze, 2) provide insight into the pathogenesis of non-asthmatic wheezing in SCD and its response to treatment, 3) explore the suitability of innovative clinical trial designs to overcome the challenges that have hindered therapeutic innovation for SCD.

Conditions Studied

Sickle Cell Disease

Interventions

  • DRUG Placebo
  • DRUG Mometasone Furoate

Study Locations (1)

New York

  • Icahn School of Medicine at Mount Sinai - New York

Trial Details

FieldValue
Enrollment Target 54 participants
Start Date 2014-03
Est. Completion 2017-11
Phase Phase 2

Sponsor

Jeffrey Glassberg

2 total trials

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What the Registry Record Tells You About NCT02061202

The ClinicalTrials.gov registry entry for NCT02061202 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 293-participant average among 213 other Sickle Cell Disease trials with a reported enrollment target (82% lower). The listed sponsor is Jeffrey Glassberg, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Sickle Cell Disease appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.

NCT02061202 reports 1 study location spanning 1 distinct geographic area - top geographies include New York.

Frequently Asked Questions

What is clinical trial NCT02061202 about?

NCT02061202 is a clinical study titled "Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease". The proposed research is designed to test the global hypothesis that inhaled corticosteroids (ICS), a therapy developed to treat asthma, will prevent vasoocclusive painful episodes in adults with Sickle Cell Disease (SCD) who wheeze, but do not meet criteria for a diagnosis of asthma. The specific a...

What is the current status of trial NCT02061202?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 54 participants. The study started on 2014-03. Estimated completion is 2017-11.

What conditions does trial NCT02061202 study?

This clinical trial studies the following conditions: Sickle Cell Disease.

What interventions are being tested in trial NCT02061202?

The interventions under investigation include: Placebo (DRUG), Mometasone Furoate (DRUG).

Who is sponsoring clinical trial NCT02061202?

This trial is sponsored by Jeffrey Glassberg, which has 2 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT02061202 being conducted?

This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.