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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Study Completion Date

2017-11-30

Brief Summary

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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.

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Detailed Description

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Conditions

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Sickle Cell Disease

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Mometasone Furoate

1 puff daily (220mcg) for 16 weeks

Group Type EXPERIMENTAL

Mometasone Furoate

Intervention Type DRUG

inhaled cortico-steroid (ICS) with a dosage of 220mcg once daily for 16 weeks

Placebo

1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo).

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

placebo training inhaler with the same instructions as the experimental group.

Interventions

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Mometasone Furoate

inhaled cortico-steroid (ICS) with a dosage of 220mcg once daily for 16 weeks

Intervention Type DRUG

Placebo

placebo training inhaler with the same instructions as the experimental group.

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No