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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 January 2022 |
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Main ID: |
NCT02432560 |
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Date of registration:
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04/03/2015 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Safety and Durability of Sirolimus for Treatment of LAM
MIDAS |
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Scientific title:
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Multicenter International Durability and Safety of Sirolimus in LAM Trial (MIDAS) |
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Date of first enrolment:
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March 2015 |
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Target sample size:
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600 |
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Recruitment status: |
Recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02432560 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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United States
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Contacts
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Name:
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Francis X McCormack, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Cincinnati |
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Name:
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Susan McMahan Sellers, BSN, RN |
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Address:
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Telephone:
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(513) 558-4376 |
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Email:
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susan.mcmahan@uc.edu |
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Affiliation:
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Female, age 18 or over
- Diagnosis of LAM
- Signed and dated informed consent
- On chronic therapy, newly treated or may be considered for therapy with mTOR
inhibitors or previously intolerant of or having failed mTOR inhibitor therapy
Exclusion Criteria:
- Inability to attend at least one RLD Clinic visit per year
- Inability to give informed consent
- Inability or unwillingness to perform pulmonary function testing
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Lymphangioleiomyomatosis
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Intervention(s)
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Drug: Everolimus
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Drug: Sirolimus
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Primary Outcome(s)
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Efficacy - annual change in spirometry
[Time Frame: 2 years]
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Long term safety of mTOR inhibitor treatment in LAM
[Time Frame: 2 years]
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Efficacy - 10% reduction in FVC1
[Time Frame: 2 years]
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Efficacy -10% reduction in FEV1
[Time Frame: 2 years]
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Efficacy - FEV1 slope
[Time Frame: 2 years]
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Secondary Outcome(s)
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Effect of long term sirolimus on quality of life
[Time Frame: 2 years]
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Secondary ID(s)
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1U54HL127672
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MIDAS
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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