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

Tracking Information
First Submitted Date  ICMJE January 14, 2014
First Posted Date  ICMJE February 12, 2014
Results First Submitted Date  ICMJE October 26, 2018
Results First Posted Date  ICMJE March 11, 2019
Last Update Posted Date March 11, 2019
Study Start Date  ICMJE March 2014
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
Feasibility [ Time Frame: at 2 years ]
Feasibility will be 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 History Complete list of historical versions of study NCT02061202 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 8, 2019)
  • 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
Original Secondary Outcome Measures  ICMJE
 (submitted: February 11, 2014)
  • Change in Effects of inhaled corticosteroids on pulmonary inflammation [ Time Frame: Before ICS therapy begins and at 8 weeks post enrollment ]
  • Change in Effects of inhaled corticosteroids vascular injury [ Time Frame: Before ICS therapy begins and at 8 weeks post enrollment ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Inhaled Mometasone to Reduce Painful Episodes in Patients With Sickle Cell Disease
Official Title  ICMJE Inhaled Mometasone to Promote Reduction in Vasoocclusive Events
Brief Summary 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Sickle Cell Disease
Intervention  ICMJE
  • Drug: Mometasone Furoate
    inhaled cortico-steroid (ICS) with a dosage of 220mcg once daily for 16 weeks
  • Drug: Placebo
    placebo training inhaler with the same instructions as the experimental group.
Study Arms  ICMJE
  • Experimental: Mometasone Furoate
    1 puff daily (220mcg) for 16 weeks
    Intervention: Drug: Mometasone Furoate
  • Placebo Comparator: Placebo
    1 puff daily for 16 weeks. Training inhaler that does not contain any medication (placebo).
    Intervention: Drug: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 8, 2019)
54
Original Estimated Enrollment  ICMJE
 (submitted: February 11, 2014)
45
Actual Study Completion Date  ICMJE November 2017
Actual Primary Completion Date November 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02061202
Other Study ID Numbers  ICMJE GCO 12-1565
K23HL119351 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Jeffrey Glassberg, Icahn School of Medicine at Mount Sinai
Study Sponsor  ICMJE Jeffrey Glassberg
Collaborators  ICMJE National Heart, Lung, and Blood Institute (NHLBI)
Investigators  ICMJE
Principal Investigator: Jeffrey Glassberg, MD, MA Icahn School of Medicine at Mount Sinai
PRS Account Icahn School of Medicine at Mount Sinai
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP