Inhaled Mometasone to Promote Reduction in Vasoocclusive Events 2

• Status: Recruiting
• Trial end date: 2023-06-30
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Jeffrey Glassberg
• Collaborator: National Heart, Lung, and Blood Institute (NHLBI)
• Treatments: Mometasone Furoate

Criteria

Inclusion Criteria:

• 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).

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.