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Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis.

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ClinicalTrials.gov Identifier: NCT03988816
Recruitment Status : Recruiting
First Posted : June 17, 2019
Last Update Posted : June 17, 2019
Sponsor:
Information provided by (Responsible Party):
University of Sao Paulo General Hospital

Brief Summary:

Although relatively common, bronchiectasis is considered an orphan disease as there is little evidence for adequate treatment, most of the therapeutic options are extrapolated from studies with patients with chronic obstructive pulmonary disease (COPD) or cystic fibrosis (CF). Inhaled bronchodilators and corticosteroids should be used as a therapeutic test and maintained if there is improvement of symptoms or lung function. There is no evidence to justify the use of mucolytic agents for these patients. The treatment with greater evidence is the use of macrolides, especially azithromycin. A meta-analysis published in 2014 showed that there was a reduction in the number of exacerbations, an improvement in the quality of life and a reduction in the decrease in FEV1. However, studies have shown conflicting results regarding quality of life and pulmonary function.

Roflumilast is a phosphodiesterase-4 inhibitor with an anti-inflammatory effect in vitro and in vivo due to the inhibition of cyclic adenosine monopostat breakdown (cAMP) to its inactive phosphodiesterase form. As this enzyme is expressed in high concentrations in leukocytes and other inflammatory cells responsible for the pathogenesis of pulmonary diseases such as COPD, it has been studied and used for this disease. COPD is characterized by a chronic inflammatory process of the airways, predominantly neutrophils and high levels of proinflammatory cytokines related to this cell, such as interleukin-8, neutrophil elastase, tumor necrosis factor (TNF) alpha and E-selectin. The REACT study showed that roflumilast prevents moderate and severe infectious exacerbations in addition to improved lung function in patients with COPD who continue to exacerbate despite the use of combined bronchodilator and inhaled corticosteroid therapy.

Since bronchiectasis and COPD are chronic inflammatory diseases, they present similar inflammatory processes, with neutrophil as the main inflammatory cell, it is expected that the use of roflumilast also has an anti-inflammatory effect in bronchiectasis. In addition, since bronchiectasis is a disease with poor evidence for pharmacological treatment, it is necessary to search for new therapeutic possibilities.


Condition or disease Intervention/treatment Phase
Bronchiectasis Adult Drug: Roflumilast Drug: Placebo oral tablet Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Placebo-controlled
Primary Purpose: Treatment
Official Title: Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Non-cystic Fibrosis Bronchiectasis: a Cross-over, Unicentric, Double-blind and Placebo-controlled Study
Estimated Study Start Date : July 2019
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Roflumilast

Arm Intervention/treatment
Experimental: Roflumilast
Roflumilast tablets will be supplied at a concentration of 500 mcg. Each tablet contains 500mcg of the active ingredient in addition to the excipients: lactose monohydrate, corn starch, povidone and magnesium stearate. The coating contains hypromellose, macrogol, titanium dioxide, yellow iron oxide. Patients should take 1 tablet once daily, before, during or after meals, at the same time each day.
Drug: Roflumilast
500Mcg Tab, once daily

Placebo Comparator: Placebo (control)
Roflumilast placebo-containing tablets will look similar to active roflumilast tablets and will be supplied to patients in packs identical to those of the active drug.
Drug: Placebo oral tablet
once daily




Primary Outcome Measures :
  1. Quality of life questionnaire [ Time Frame: 12 weeks ]
    To evaluate the impact of roflumilast on the quality of life of patients with bronchiectasis through the Saint George Respiratory Questionnaire (SGRQ).


Secondary Outcome Measures :
  1. Other tools for quality of life [ Time Frame: 12 weeks ]
    To evaluate the impact of roflumilast on quality of life using the questionnaires Leicester, Quality of Life Questionnaire-Bronchiectasis (QOL-B) Bronchiectasis Health Questionnaire (BHQ)

  2. Dyspnea [ Time Frame: 12 weeks ]
    To evaluate the impact of roflumilast on severity of dyspnea as measured by the COPD Assessment Test (CAT)

  3. Lung function [ Time Frame: 12 weeks ]
    To evaluate the impact of roflumilast on lung function measured by forced expiratory volume at one second (FEV1)

  4. Adverse events [ Time Frame: 12 weeks ]
    To evaluate the safety of roflumilast assessed through the incidence of adverse events



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Age > 18 years;
  • Diagnosis of bronchiectasis by chest tomography;
  • FEV1 <60% of predicted;
  • History of chronic bronchitis (chronic cough and sputum for at least 3 months in the last 2 years);
  • 2 or more infectious exacerbations in the last year (defined as worsening of cough and / or dyspnoea and / or decreased general condition, increased quantity and purulence of sputum that required systemic antibiotic use (oral or intravenous).

Exclusion Criteria:

  • Hemoptysis in the last 6 months (significance at the discretion of the investigator);
  • Current or prior smoking if > 10 pack-years;
  • FEV1 < 30% of predicted;
  • Known allergy to roflumilast;
  • Pulmonary exacerbation present or occurring in the last 4 weeks;
  • Child B or C cirrhosis;
  • Active cancer (except basal cell carcinoma);
  • Severe heart failure;
  • Depression associated with suicidal ideation;
  • Pregnancy.

Information from the National Library of Medicine

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): NCT03988816


Contacts
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Contact: Rodrigo A Athanazio, MD, PhD +55 11 2661-5000 ext 5685 rathanazio@yahoo.com.br

Locations
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Brazil
Heart Institute (InCor) - Hospital das Clínicas da Faculdade de Medicina da Universidade de São Paulo Recruiting
São Paulo, SP, Brazil, 05403-900
Contact: Rodrigo A Athanazio, MD, PhD    +55 11 2661-5000 ext 5685    rathanazio@yahoo.com.br   
Contact: Blenda Nunes, MD    +55 11 2661-5000 ext 5685    blendaendlich@gmail.com   
Sponsors and Collaborators
University of Sao Paulo General Hospital
Investigators
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Principal Investigator: Rodrigo A Athanazio, MD, PhD Medical Assistant

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Responsible Party: University of Sao Paulo General Hospital
ClinicalTrials.gov Identifier: NCT03988816     History of Changes
Other Study ID Numbers: SDC 4706/18/057
First Posted: June 17, 2019    Key Record Dates
Last Update Posted: June 17, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Sao Paulo General Hospital:
bronchiectasis
lung function
quality of life
mucus properties
Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases