Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease

Completed · Phase 2 · Has a placebo group

Conditions studied: Sickle Cell Disease

In brief

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 Sickle Cell Disease (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.

Key facts

Study ID

NCT02061202

Run by

Jeffrey Glassberg

People needed

54

Starts

2014-03-01

Expected to finish

2017-11-01

Last updated by the study team

2019-03-11

Who can join

Age: 15 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Age 15 or older
• Sever SCD phenotypes (Hb SS and Sβthalassemia0)
• A positive response to cough/wheeze questions

You may not qualify if…

• 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

Where it is running

• Icahn School of Medicine at Mount Sinai — New York, New York, United States

Full record on ClinicalTrials.gov

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