Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease (IMPROVE)
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|ClinicalTrials.gov Identifier: NCT02061202|
Recruitment Status : Completed
First Posted : February 12, 2014
Results First Posted : March 11, 2019
Last Update Posted : March 11, 2019
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|Condition or disease||Intervention/treatment||Phase|
|Sickle Cell Disease||Drug: Mometasone Furoate Drug: Placebo||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||54 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||Inhaled Mometasone to Promote Reduction in Vasoocclusive Events|
|Study Start Date :||March 2014|
|Actual Primary Completion Date :||November 2017|
|Actual Study Completion Date :||November 2017|
Experimental: Mometasone Furoate
1 puff daily (220mcg) for 16 weeks
Drug: Mometasone Furoate
inhaled cortico-steroid (ICS) with a dosage of 220mcg once daily for 16 weeks
Placebo Comparator: Placebo
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo).
placebo training inhaler with the same instructions as the experimental group.
- Number of Participants Who Completed Follow up [ Time Frame: at 2 years ]Feasibility is determined by calculating the proportion of randomized participants who complete follow up and a minimum of 30 pain diaries with good adherence to the study medication vs. the number enrolled.
- Change in Exhaled Nitric Oxide (eNO) [ Time Frame: Before ICS therapy begins and at 8 weeks post enrollment ]Change in effects of inhaled corticosteroids (ICS) as measured by exhaled nitric oxide levels, which is the primary marker of pulmonary inflammation.
- Change in Soluble Vascular Cell Adhesion Molecule (sVCAM) Level [ Time Frame: Before ICS therapy begins and at 8 weeks post enrollment ]Mean Change in effects of inhaled corticosteroids vascular injury, assessed by biomarker sVCAM as a surrogate for vascular injury.
- Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me) [ Time Frame: baseline and week 20 ]Mean changes in ASCQ-Me (NHLBI developed a patient-reported Sickle Cell Disease (SCD) quality of life measurement tool) pain impact, at week 20 as compared to baseline. A reduction change on a 100-point scale indicated improved quality of life. ASCQ-Me uses a T-score metric (0-100) in which 50 is the mean of the reference population and 10 is the standard deviation (SD) of that population.
- The Medication Adherence Report Scale [ Time Frame: 20 weeks ]The medication adherence report scale for asthma is a 10 question tool scored between 0 and 5, with full scale from 0 to 25, with higher scores indicating greater adherence
- Change in the Numerical Rating Scale (NRS) for Pain [ Time Frame: baseline and 20 weeks ]Mean change in patient reported pain NRS score, full scale range 0- 10, higher score indicate more pain
- Asthma Control Test [ Time Frame: 8 weeks ]Asthma control test, total score from 0-25, with higher score indicating more symptoms
- Admissions or Visits to the Hospital [ Time Frame: baseline through 8 weeks ]Number of times participant visited the Emergency Department (ED) or was admitted to the hospital
- Change in Reticulocytes Count [ Time Frame: baseline and 8 weeks ]Mean change in reticulocytes count - the number of new red blood cells.
- Change in FEV1/FVC [ Time Frame: baseline and 8 weeks ]Mean change in FEV1/FVC at 8 weeks compared to baseline
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|Ages Eligible for Study:||15 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- Age 15 or older
- Sever SCD phenotypes (Hb SS and Sβthalassemia0)
- A positive response to cough/wheeze questions
- 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061202
|United States, New York|
|Icahn School of Medicine at Mount Sinai|
|New York, New York, United States, 10029|
|Principal Investigator:||Jeffrey Glassberg, MD, MA||Icahn School of Medicine at Mount Sinai|
Documents provided by Jeffrey Glassberg, Icahn School of Medicine at Mount Sinai:
|Responsible Party:||Jeffrey Glassberg, Assistant Professor, Icahn School of Medicine at Mount Sinai|
|Other Study ID Numbers:||
K23HL119351 ( U.S. NIH Grant/Contract )
|First Posted:||February 12, 2014 Key Record Dates|
|Results First Posted:||March 11, 2019|
|Last Update Posted:||March 11, 2019|
|Last Verified:||March 2019|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
Sickle Cell Disease
Anemia, Sickle Cell
Genetic Diseases, Inborn
Anemia, Hemolytic, Congenital