Inhaled Mometasone to Promote Reduction in Vasoocclusive Events 2

About the study

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.

Study point of contact

Jeffrey Glassberg, MD
212-241-3650
[email protected]
Cindy Clesca, BA
212-824-8057
[email protected]

Locations

2 United States sites

Age

> 18 Years

Genotypes

Hb SS

Phase

Phase 2

Study type

Interventional

Gender

All

Interventions

Drug

participation requirements

Participants age 18 and older with severe SCD phenotypes (Hb SS and SĪ²thalassemia0):
Do not have asthma (see

participation restrictions

)
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).

Exclusion Criteria:

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.

Locations

  • New York, New York, United States, Mount Sinai St Luke's
  • New York, New York, United States, Icahn School of Medicine at Mount Sinai
Last updated 2020-11-24