Status:
COMPLETED
Inhaled Mometasone to Promote Reduction in Vasoocclusive Events 2
Lead Sponsor:
Jeffrey Glassberg
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief 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 C...
Detailed Description
Dose rationale: Mometasone furoate 220mcg dry powder inhalation is a low-moderate ICS dose that can be given once daily. Higher doses can have systemic effects and systemic glucocorticoids can precipi...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 29 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 31 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT03758950
Start Date
November 29 2018
End Date
May 31 2023
Last Update
June 18 2023
Active Locations (2)
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1
Mount Sinai St Luke's
New York, New York, United States, 10025
2
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10029