Benzbromarone medication treatment to improve Respiratory Health and Quality of Life for patients with Cystic Fibrosis

Benzbromarone for the treatment of Cystic Fibrosis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

REBEC

Registry ID

RBR-5wvg53s

Enrollment

Unknown

Registered

2021-01-05

Start date

2021-05-01

Completion date

Unknown

Last updated

2025-10-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cystic Fibrosis

Interventions

The patients included in the study will receive, in addition to the standard treatment for cystic fibrosis (physiotherapy, food supplementation and / or fat-soluble vitamins, replacement of pancreatic

N02.421.668.438

Eligibility

Age

6 Years to 30 Years

Inclusion criteria

Inclusion criteria: Confirmed diagnosis of cystic fibrosis based on the following criteria: Positive sweat chloride 60 mEq liter; A genotype with two pathogenic CF mutations identified; FEV1 with values between 40% and 90% of that predicted in spirometry; Female patients who deny sexarche

Exclusion criteria

Exclusion criteria: Beginning of any new therapy, for example, ibuprofen, Pulmozyme, hypertonic saline, azithromycin, TOBI, Cayston within four weeks before the start of the study; Episode of pulmonary exacerbation in the period of four weeks before the start of the study; Significant hemoptysis in the period of four weeks prior to the start of the study, 5 mL of blood in a coughing episode or 30 mL of blood in a 24 hour period; Abnormal liver function, TGO and TGP at levels three times above the reference values; Abnormal renal function, glomerular filtration rate, GFR, below 60mL min and 1.73m2 according to the calculation estimated by the Schwartz formula; Use of an experimental drug within four weeks before the start of the study; Use of intravenous or oral steroids within four weeks before the start of the study; Patients submitted to the list of lung transplant and or transplanted.

Design outcomes

Secondary

Measure	Time frame
It is expected to find an improvement of 2 to 5 points in each domain in the quality of life scores between days zero, 15-45 and 90-100, assessed by applying a quality of life questionnaire adapted for patients with cystic fibrosis (CFQ-R);A 1 to 4 fold decrease in the number of pulmonary exacerbations is expected during the study period, expressed by the use of antibiotics by means of a clinical record;It is expected to find a decrease in inflammatory mediators expressed by the variables TNF-alpha, IL-1, IL-6 and IL-8 in spontaneous sputum samples on days zero, 15-45 and 90-100	—

Measure

Time frame

It is expected to find an improvement of 2 to 5 points in each domain in the quality of life scores between days zero, 15-45 and 90-100, assessed by applying a quality of life questionnaire adapted for patients with cystic fibrosis (CFQ-R);A 1 to 4 fold decrease in the number of pulmonary exacerbations is expected during the study period, expressed by the use of antibiotics by means of a clinical record;It is expected to find a decrease in inflammatory mediators expressed by the variables TNF-alpha, IL-1, IL-6 and IL-8 in spontaneous sputum samples on days zero, 15-45 and 90-100

—

Primary

Measure	Time frame
It is expected to find an improvement in lung function expressed as a greater than 5% increase in forced expiratory volume in the first second (FEV1) between baseline and final measurements (15-45, 90-100 days) of treatment using the spirometry test	—

Countries

Brazil

Contacts

Public ContactLeonardo Pinto

Pontifícia Universidade Católica do Rio Grande do Sul (PUCRS)

leonardo.pinto@pucrs.br+ 55 (51) 3320.3500

Outcome results

None listed

Source: REBEC (via WHO ICTRP) · Data processed: Feb 11, 2026