Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosis

Phase 1

• Conditions: Cystic Fibrosis; MedDRA version: 20.0Level: LLTClassification code 10074550Term: Preventive antimicrobial therapy in cystic fibrosisSystem Organ Class: 100000004865; MedDRA version: 20.0Level: LLTClassification code 10011764Term: Cystic fibrosis NOSSystem Organ Class: 100000004850; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2016-004033-25-ES
• Lead Sponsor: Fundació Parc Taulí

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-03-31
• Last Update Posted: 23 October 2023

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 70

Inclusion Criteria

- Patients of both genders with CF diagnosis.
- FEV1> 40%.
- Age over 6 years.
- Patients with sputum culture negative for Pseudomonas
- Patients who give their informed consent or whose representative gives informed consent to participate in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 50
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 20
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Pregnant or lactating women
- Women of childbearing potential, not using valid contraceptive methods:
- Abstinence
- Surgical sterilization
- Male partner sterilization
- Barrier contraceptive methods
- Hormonal contraceptive methods or other with similar efficacy
- Baseline oxygen saturation <92% or supplementary oxygen needs at home.
- Masive Hemoptysis
- Patients colonized by pseudomonas
- Patients who are not able to follow study assessments according to protocol
- Any circumstance that at the discretion of the physician may pose a risk or clinical harm to the patient's participation in the study or interfere with the assessments of the same.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified