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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 inflammation

Change 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

Page last updated: August 23, 2015

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