Inhaled Mometasone to Promote Reduction in Vasoocclusive Events 2

Completed · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

The study team proposes a triple-blind, placebo-controlled, phase II clinical trial of once-daily inhaled mometasone for 48 weeks (with 4-week washout at study completion) in individuals with Sickle Cell Disease (SCD) who report episodic cough or wheeze (ECW) but do not have asthma. Patients will be recruited from and followed in SCD clinics at participating sites. The primary endpoint will be a reduction in sVCAM level of 20% or more in comparison to placebo.

Key facts

Study ID

NCT03758950

Run by

Jeffrey Glassberg

People needed

80

Starts

2018-11-29

Expected to finish

2023-05-31

Last updated by the study team

2023-06-18

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants age 18 and older with severe SCD phenotypes (Hb SS and Sβthalassemia0):
• Do not have asthma (see exclusion criteria)
• Not currently having a painful crisis (as defined by validated pain diary questions)
• Do not have acute respiratory symptoms
• Report of recent ECW (answers "Yes" to any question in Box 1)
• Participant is already medically optimized (i.e. already on maximum dose hydroxyurea unless contraindicated and not undergoing medication titration).

You may not qualify if…

• Participant screens positive for possible undiagnosed asthma (Box 2)
• Pregnant or planning to become pregnant
• > 15 ED visits for SCD pain over the previous 12 months (due to concern for multi-factorial pain that may be less responsive to SCD therapies)
• Have been discharged from the hospital within the previous 7 days.

Where it is running

• Mount Sinai St Luke's — New York, New York, United States
• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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