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Trial record 2 of 2 for:    corticosteroids | Sickle Cell Disease
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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
Sponsor:
Collaborator:
National Heart, Lung, and Blood Institute (NHLBI)
Information provided by (Responsible Party):
Jeffrey Glassberg, Icahn School of Medicine at Mount Sinai

Study Type Interventional
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
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
Hide Arm/Group Description 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
Arm/Group Title Mometasone Furoate Placebo Total
Hide Arm/Group Description 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
Hide Baseline Analysis Population Description
1 participant in each group was lost to follow up prior to data collection and excluded from analyses.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
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
Number Analyzed 35 participants 17 participants 52 participants
Female
18
  51.4%
6
  35.3%
24
  46.2%
Male
17
  48.6%
11
  64.7%
28
  53.8%
Race and Ethnicity Not Collected   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 0 participants 0 participants 0 participants
0
[1]
Measure Analysis Population Description: Race and Ethnicity were not collected from any participant.
1.Primary Outcome
Title Number of Participants Who Completed Follow up
Hide Description 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.
Time Frame at 2 years
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description:
1 puff daily (220mcg) for 16 weeks
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
Overall Number of Participants Analyzed 36 18
Measure Type: Count of Participants
Unit of Measure: Participants
35
  97.2%
17
  94.4%
2.Secondary Outcome
Title Change in Exhaled Nitric Oxide (eNO)
Hide Description Change in effects of inhaled corticosteroids (ICS) as measured by exhaled nitric oxide levels, which is the primary marker of pulmonary inflammation.
Time Frame Before ICS therapy begins and at 8 weeks post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description:
1 puff daily (220mcg) for 16 weeks
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
Overall Number of Participants Analyzed 35 17
Mean (95% Confidence Interval)
Unit of Measure: ppb
0.63
(-2.51 to 3.77)
2.71
(0.48 to 5.90)
3.Secondary Outcome
Title Change in Soluble Vascular Cell Adhesion Molecule (sVCAM) Level
Hide Description Mean Change in effects of inhaled corticosteroids vascular injury, assessed by biomarker sVCAM as a surrogate for vascular injury.
Time Frame Before ICS therapy begins and at 8 weeks post enrollment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description:
1 puff daily (220mcg) for 16 weeks
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
Overall Number of Participants Analyzed 35 17
Mean (Standard Deviation)
Unit of Measure: ng/mL
-182.47  (785.21) 170.25  (182.39)
4.Secondary Outcome
Title Change in Adult Sickle Cell Quality of Life Measurement Information System (ASCQ-Me)
Hide Description 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.
Time Frame baseline and week 20
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description:
1 puff daily (220mcg) for 16 weeks
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
Overall Number of Participants Analyzed 35 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.8  (22.7) 6.9  (24.0)
5.Secondary Outcome
Title The Medication Adherence Report Scale
Hide Description 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
Time Frame 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description:
1 puff daily (220mcg) for 16 weeks
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
Overall Number of Participants Analyzed 35 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
17.7  (2.25) 17.1  (1.78)
6.Secondary Outcome
Title Change in the Numerical Rating Scale (NRS) for Pain
Hide Description Mean change in patient reported pain NRS score, full scale range 0- 10, higher score indicate more pain
Time Frame baseline and 20 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description:
1 puff daily (220mcg) for 16 weeks
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
Overall Number of Participants Analyzed 35 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
2.09  (2.55) 2.82  (2.21)
7.Secondary Outcome
Title Asthma Control Test
Hide Description Asthma control test, total score from 0-25, with higher score indicating more symptoms
Time Frame 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description:
1 puff daily (220mcg) for 16 weeks
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
Overall Number of Participants Analyzed 35 17
Mean (Standard Deviation)
Unit of Measure: score on a scale
17.7  (2.25) 17.1  (1.78)
8.Secondary Outcome
Title Admissions or Visits to the Hospital
Hide Description Number of times participant visited the Emergency Department (ED) or was admitted to the hospital
Time Frame baseline through 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description:
1 puff daily (220mcg) for 16 weeks
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
Overall Number of Participants Analyzed 35 17
Mean (Standard Deviation)
Unit of Measure: Events
ED visits 0.97  (1.52) 1.12  (1.87)
Observation admits 0.37  (0.77) 0.59  (1.18)
Admissions 0.37  (0.77) 0.47  (1.23)
9.Secondary Outcome
Title Change in Reticulocytes Count
Hide Description Mean change in reticulocytes count - the number of new red blood cells.
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description:
1 puff daily (220mcg) for 16 weeks
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
Overall Number of Participants Analyzed 35 17
Mean (Standard Deviation)
Unit of Measure: 10^3 cells/μL
-0.15  (0.39) 0.07  (0.52)
10.Secondary Outcome
Title Change in FEV1/FVC
Hide Description Mean change in FEV1/FVC at 8 weeks compared to baseline
Time Frame baseline and 8 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description:
1 puff daily (220mcg) for 16 weeks
1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
Overall Number of Participants Analyzed 35 17
Mean (Standard Deviation)
Unit of Measure: ratio
-0.71  (3.42) -1.41  (3.39)
Time Frame 2 years
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Mometasone Furoate Placebo
Hide Arm/Group Description 1 puff daily (220mcg) for 16 weeks 1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo)
All-Cause Mortality
Mometasone Furoate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/17 (0.00%) 
Show Serious Adverse Events Hide Serious Adverse Events
Mometasone Furoate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)   0/17 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Mometasone Furoate Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   15/35 (42.86%)   5/17 (29.41%) 
Respiratory, thoracic and mediastinal disorders     
Hoarseness of voice † 1  15/35 (42.86%)  4/17 (23.53%) 
Thrush † 1  2/35 (5.71%)  0/17 (0.00%) 
Sore Throat † 1  15/35 (42.86%)  5/17 (29.41%) 
1
Term from vocabulary, CTCAE (Unspecified)
†
Indicates events were collected by systematic assessment
[Not Specified]
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
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):
Layout table for additonal information
Responsible Party: Jeffrey Glassberg, Icahn School of Medicine at Mount Sinai
ClinicalTrials.gov Identifier: NCT02061202     History of Changes
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