Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis
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|ClinicalTrials.gov Identifier: NCT04090294|
Recruitment Status : Unknown
Verified September 2019 by Maha Ahmed Abd El-Gawad Mohamed Okash, Assiut University.
Recruitment status was: Not yet recruiting
First Posted : September 16, 2019
Last Update Posted : October 3, 2019
Aim of the work
Assessment of early outcome of using Roflumilast in patients with bronchiectasis regarding:
- Severity of symptoms
- Frequency of exacerbations
- Change in pulmonary function
- Systemic inflammation
|Condition or disease||Intervention/treatment||Phase|
|Bronchiectasis||Drug: Roflumilast||Early Phase 1|
Bronchiectasis is defined by the presence of permanent and abnormal dilation of the bronchi. This usually occurs in the context of chronic airway infection causing inflammation. The main clinical manifestation is a productive cough. Bronchiectasis is currently nearly always diagnosed using high-resolution computed tomography (HRCT) scanning. The main diagnostic features are: 1) internal diameter of a bronchus is wider than its adjacent pulmonary artery; 2) failure of the bronchi to taper; and 3) visualization of bronchi in the outer 1-2 cm of the lung fields.
- From a series of benzamide derivatives, roflumilast (3-cyclo-propylmethoxy-4-difluoromethoxy-N-[3,5-di-chloropyrid-4-yl]-benzamide) was identified as a potent and selective PDE4 inhibitor. It inhibits PDE4 activity from human neutrophils. PDE4 inhibitors were demonstrated to inhibit inflammatory cytokine and mediator release from inflammatory cells. In addition, it inhibits neutrophil chemotaxis or migratory activity. Lastly, PDE4 inhibitor promotes apoptosis of these cells .
- Studies have demonstrated the efficacy of roflumilast in patients with both asthma and COPD, where roflumilast improved lung function and reduced exacerbation rates.
Bronchiectasis is a chronic destructive lung disease, which is characterised by persistent bacterial colonization, bronchial inflammation, reduced mucociliaryclearance, and in some patients progressive tissue damage. There is evidence of an associated influx of neutrophils into the lungs of these patients , resulting in the expectoration of large volumes of purulent sputum containing neutrophils and their products, so In patients with bronchiectasis, there is also neutrophilic inflammation as in COPD.
- The PDE4 inhibitor, roflumilast, was evaluated in short term clinical trial of non-cystic fibrosis bronchiectasis. It has been shown symptomatic improvement from baseline Park J. found that 16 weeks Roflumilast treatment in patients with non cystic fibrosis bronchiectasis significantly reduce CAT score and improve the symptoms of non-CF bronchiectasis.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||35 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||35 patients will receive roflumilast for three months and improvement regarding performance , frequency of exacerbation and pulmonary function test will be assessed.|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis|
|Estimated Study Start Date :||October 1, 2019|
|Estimated Primary Completion Date :||September 2020|
|Estimated Study Completion Date :||November 2020|
Experimental: Roflumilast -non roflumilast
35 patients will receive Roflumilast for three months and improvement regarding dyspnea scales , Pulmonary function Test , Six minutes walking test and bronchectasis severity index (FACED) score pre and post therapy will be assessed.
patients will receive Roflumilast 500 Mcg. Tablet Once daily for Three months and then base line assessment will be repeated to evaluate improvement.
Roflumilast is a phosphodiesterase (PDE) type 4 inhibitor will be prescribed for three month for the study group. the patients will then be assessed for improvement regarding exacerbation frequency , performance and pulmonary function test.
patients will receive Roflumilast 500 Mcg. Tablet once daily for three months
Other Name: phosphodiestrase 4 inhibitor (PDE4)
- 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). ]Assessment of efficacy of Roflumilast on severity of symptoms in patients with bronchiectasis. Frequency of Exacerbation in the three months assessment and need of hospitalization will be the main parameter for efficacy of the new treatment described as number/ 3 months
- 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). ]Assessment of efficacy of roflumilast on change dyspnea scale namely mMRCP evaluated at the start of the study and after 1 month and 3 months
- 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). ]Assessment of efficacy of roflumilast on change in pulmonary function test in patients with bronchiectasis regarding : change in FEV1 by liter per second
- 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). ]Assessment of efficacy of roflumlilast on severity of symptoms in patients with bronchiactasis evaluated by bronchectasis severity index (FACED) score.
- 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). ]Assessment of efficacy of roflumlilast on systemic inflammation in patients with bronchiectasis regarding CRP by mg per L
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04090294
|Contact: Maha Ahmed Okasha, Residentfirstname.lastname@example.org|
|Contact: Ahmad Shaddad, Lectureremail@example.com|
|Principal Investigator:||Ahmad Shaddad, Lecturer||Assuit University - Assuit - Egypt|