Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis

NCT04090294 | Unknown Early Phase 1

• 1 other identifier: Roflumilast in bronchiectasis
• Study Type: interventional
• Target: 35
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Bronchiectasis

Outcome Measures

Primary Outcomes (5)

• Assessment of efficacy of Roflumlilast regarding control of patients with non cystic fibrosis bronchiectasis

  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

  3months . outcomes will be evaluated after 1month and at the end of the study (3months).

• Assessment of efficacy of roflumlilast in change of performance in patients with non cystic fibrosis bronchiectasis

  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

  3months . outcomes will be evaluated after 1month and at the end of the study (3months).

• Assessment of efficacy of roflumlilast on change in Pulmonary function in patients with non cystic fibrosis bronchiectasis

  Assessment of efficacy of roflumilast on change in pulmonary function test in patients with bronchiectasis regarding : change in FEV1 by liter per second

  3months . outcomes will be evaluated after 1month and at the end of the study (3months).

• Assessment of efficacy of roflumlilast on change of symptoms in patients with non cystic fibrosis bronchiectasis

  Assessment of efficacy of roflumlilast on severity of symptoms in patients with bronchiactasis evaluated by bronchectasis severity index (FACED) score.

  3months . outcomes will be evaluated after 1month and at the end of the study (3months).

• Assessment of efficancy of roflumlilast on change in systemic inflammation in patients with non cystic fibrosis bronchiectasis

  Assessment of efficacy of roflumlilast on systemic inflammation in patients with bronchiectasis regarding CRP by mg per L

  3months . outcomes will be evaluated after 1 month and at the end of the study (3 months).

Study Arms (1)

Roflumilast -non roflumilast

EXPERIMENTAL

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.

Drug: Roflumilast

Interventions

Roflumilast DRUG

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

Also known as: phosphodiestrase 4 inhibitor (PDE4)

Roflumilast -non roflumilast

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Sousa LP, Lopes F, Silva DM, Tavares LP, Vieira AT, Rezende BM, Carmo AF, Russo RC, Garcia CC, Bonjardim CA, Alessandri AL, Rossi AG, Pinho V, Teixeira MM. PDE4 inhibition drives resolution of neutrophilic inflammation by inducing apoptosis in a PKA-PI3K/Akt-dependent and NF-kappaB-independent manner. J Leukoc Biol. 2010 May;87(5):895-904. doi: 10.1189/jlb.0809540. Epub 2010 Jan 26.

  PMID: 20103769 BACKGROUND

• Barker AF. Bronchiectasis. N Engl J Med. 2002 May 2;346(18):1383-93. doi: 10.1056/NEJMra012519. No abstract available.

  PMID: 11986413 BACKGROUND

• Grootendorst DC, Gauw SA, Verhoosel RM, Sterk PJ, Hospers JJ, Bredenbroker D, Bethke TD, Hiemstra PS, Rabe KF. Reduction in sputum neutrophil and eosinophil numbers by the PDE4 inhibitor roflumilast in patients with COPD. Thorax. 2007 Dec;62(12):1081-7. doi: 10.1136/thx.2006.075937. Epub 2007 Jun 15.

  PMID: 17573446 BACKGROUND

• van Schalkwyk E, Strydom K, Williams Z, Venter L, Leichtl S, Schmid-Wirlitsch C, Bredenbroker D, Bardin PG. Roflumilast, an oral, once-daily phosphodiesterase 4 inhibitor, attenuates allergen-induced asthmatic reactions. J Allergy Clin Immunol. 2005 Aug;116(2):292-8. doi: 10.1016/j.jaci.2005.04.023.

  PMID: 16083782 BACKGROUND

Related Links

• 2\. King PT, Holdsworth SR, Freezer NJ, Villanueva E, Holmes PW. Characterisation of the onset and presenting clinical features of adult bronchiectasis. Respir Med. 2006;100:2183-2189. \[PubMed\] \[Google Scholar\]
• The preclinical pharmacology of roflumilast--a selective, oral phosphodiesterase 4 inhibitor in development for chronic obstructive pulmonary disease.Pulm Pharmacol Ther 2010;23:235-56. 10.1016/j.pupt.201

MeSH Terms

Conditions

Bronchiectasis

Interventions

Roflumilast

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Study Officials

• Ahmad Shaddad, Lecturer

  Assuit University - Assuit - Egypt

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Maha Ahmed Okasha, Resident

CONTACT

01002660421; maha.ahmed201388@gmail.com

Ahmad Shaddad, Lecturer

CONTACT

00201111171930; shaddad_ahmad@yahoo.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: 35 patients will receive roflumilast for three months and improvement regarding performance , frequency of exacerbation and pulmonary function test will be assessed.

Study Record Dates

• First Submitted: August 21, 2019
• First Posted: September 16, 2019
• Study Start: October 1, 2019
• Primary Completion: September 1, 2020
• Study Completion: November 1, 2020
• Last Updated: October 3, 2019

Record last verified: 2019-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 24 Months
• Access Criteria: open Access