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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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12 December 2020 |
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Main ID: |
NCT04090294 |
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Date of registration:
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21/08/2019 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis
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Scientific title:
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Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis |
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Date of first enrolment:
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October 1, 2019 |
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Target sample size:
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35 |
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Recruitment status: |
Not yet recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT04090294 |
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Study type:
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Interventional |
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Study design:
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Allocation: N/A. Intervention model: Single Group Assignment. Primary purpose: Treatment. Masking: None (Open Label).
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Phase:
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Early Phase 1
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Contacts
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Name:
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Maha Ahmed Okasha, Resident |
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Address:
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Telephone:
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01002660421 |
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Email:
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maha.ahmed201388@gmail.com |
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Affiliation:
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Name:
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Ahmad Shaddad, Lecturer |
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Address:
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Telephone:
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Email:
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Affiliation:
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Assuit University - Assuit - Egypt |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- Aged 18 years or above, male or female.
- Non / Ex-smokers.
- Confirmed diagnosis of bronchiectasis based on high-resolution computed tomography
scan.
- Significant sputum production (= 10 ml per day).
Exclusion Criteria:
- Non-stable patients who need ICU admission /mechanical ventilation.
- Active smokers.
- Moderate to severe liver impairment (Child-Pugh B or C) and/or sever renal impairment
(c. clearance less than 30ml/min).
- Known psychiatric illness
- Concomitant use of strong cytochrome P450 inducers (e.g. rifampicin)
- Patients who are hypersensitive to roflumilast.
- Pregnant or lactating women
Age minimum:
18 Years
Age maximum:
75 Years
Gender:
All
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Health Condition(s) or Problem(s) studied
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Bronchiectasis
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Intervention(s)
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Drug: Roflumilast
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Primary Outcome(s)
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Assessment of efficacy of roflumlilast on change of symptoms in patients with non cystic fibrosis bronchiectasis
[Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months).]
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Assessment of efficacy of roflumlilast in change of performance in patients with non cystic fibrosis bronchiectasis
[Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months).]
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Assessment of efficacy of roflumlilast on change in Pulmonary function in patients with non cystic fibrosis bronchiectasis
[Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months).]
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Assessment of efficancy of roflumlilast on change in systemic inflammation in patients with non cystic fibrosis bronchiectasis
[Time Frame: 3months . outcomes will be evaluated after 1 month and at the end of the study (3 months).]
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Assessment of efficacy of Roflumlilast regarding control of patients with non cystic fibrosis bronchiectasis
[Time Frame: 3months . outcomes will be evaluated after 1month and at the end of the study (3months).]
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Secondary ID(s)
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Roflumilast in bronchiectasis
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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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