Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease
Information source: Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Sickle Cell Disease
Intervention: Mometasone Furoate (Drug); Placebo (Drug)
Phase: Phase 2
Status: Recruiting
Sponsored by: Jeffrey Glassberg Official(s) and/or principal investigator(s): Jeffrey Glassberg, MD, MA, Principal Investigator, Affiliation: Icahn School of Medicine at Mount Sinai
Overall contact: Alexa Punzalan, BA, Phone: 212-824-8085, Email: alexa.punzalan@mountsinai.org
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 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.
Clinical Details
Official title: Inhaled Mometasone to Promote Reduction in Vasoocclusive Events
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Feasibility
Secondary outcome: Change in Effects of inhaled corticosteroids on pulmonary inflammationChange in Effects of inhaled corticosteroids vascular injury
Eligibility
Minimum age: 15 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Age 15 or older
- Sever SCD phenotypes (Hb SS and Sβthalassemia0)
- A positive response to cough/wheeze questions
Exclusion Criteria:
- Patient carries a physician diagnosis of asthma
- Patient is prescribed asthma medications
- Patient is currently having a painful crisis (as defined by validated pain diary
questions)
- Patient has acute respiratory symptoms
- Known hypersensitivity to milk proteins
- Meets criteria for our operational diagnosis of asthma
- More than 15 ED visits for pain over the preceding 12 months
- Admitted or discharged from the hospital for SCD pain within the last 7 days
Locations and Contacts
Alexa Punzalan, BA, Phone: 212-824-8085, Email: alexa.punzalan@mountsinai.org
Icahn School of Medicine at Mount Sinai, New York, New York 10029, United States; Recruiting Alexa Punzalan, BA, Phone: 212-824-8085, Email: alexa.punzalan@mountsinai.org Aria Mattias, Phone: 212-824-8089, Email: aria.mattias@mountsinai.org Jeffrey Glassberg, MD, MA, Principal Investigator
Additional Information
Starting date: March 2014
Last updated: April 8, 2015
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