Trial record 2 of 4 for:
corticosteroids | Sickle Cell Disease
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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Sponsor:
Jeffrey Glassberg
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey Glassberg, Icahn School of Medicine at Mount Sinai
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Study Type | Interventional |
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Study Design | Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor); Primary Purpose: Treatment |
Condition |
Sickle Cell Disease |
Interventions |
Drug: Mometasone Furoate Drug: Placebo |
Enrollment | 54 |
Participant Flow
Recruitment Details | Recruitment began in February 2014, with first enrollment in March 2014, and last enrollment in October 2016 |
Pre-assignment Details |
Arm/Group Title | Mometasone Furoate | Placebo |
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1 puff daily (220mcg) for 16 weeks | 1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo) |
Period Title: Overall Study | ||
Started | 36 | 18 |
Completed | 35 | 17 |
Not Completed | 1 | 1 |
Reason Not Completed | ||
Lost to Follow-up | 1 | 1 |
Baseline Characteristics
Arm/Group Title | Mometasone Furoate | Placebo | Total | |
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1 puff daily (220mcg) for 16 weeks | 1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo) | Total of all reporting groups | |
Overall Number of Baseline Participants | 35 | 17 | 52 | |
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1 participant in each group was lost to follow up prior to data collection and excluded from analyses.
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Age, Continuous
Mean (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 35 participants | 17 participants | 52 participants | |
30 (8.56) | 36 (9.81) | 32 (9.28) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 35 participants | 17 participants | 52 participants | |
Female |
18 51.4%
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6 35.3%
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24 46.2%
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Male |
17 48.6%
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11 64.7%
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28 53.8%
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Race and Ethnicity Not Collected
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 0 participants | 0 participants | 0 participants | |
0 | ||||
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
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Outcome Measures
Adverse Events
Limitations and Caveats
[Not Specified]
More Information
Results Point of Contact
Name/Title: | Dr. Jeffrey Glassberg |
Organization: | Icahn School of Medicine at Mount Sinai |
Phone: | 212-241-3650 |
EMail: | jeffrey.glassberg@mountsinai.org |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Jeffrey Glassberg, Icahn School of Medicine at Mount Sinai |
ClinicalTrials.gov Identifier: | NCT02061202 |
Other Study ID Numbers: |
GCO 12-1565 K23HL119351 ( U.S. NIH Grant/Contract ) |
First Submitted: | January 14, 2014 |
First Posted: | February 12, 2014 |
Results First Submitted: | October 26, 2018 |
Results First Posted: | March 11, 2019 |
Last Update Posted: | March 11, 2019 |