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

Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004033-25-ES

Enrollment

Registered

2017-03-31

Start date

2017-06-19

Completion date

Unknown

Last updated

2023-10-23

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

Conditions

Cystic Fibrosis MedDRA version: 20.0 Level: LLT Classification code 10074550 Term: Preventive antimicrobial therapy in cystic fibrosis System Organ Class: 100000004865 MedDRA version: 20.0 Level: LLT Classification code 10011764 Term: Cystic fibrosis NOS System Organ Class: 100000004850

Interventions

Product Name: Sodium bicarbonate Pharmaceutical Form: Solution for injection INN or Proposed INN: Sodium Bicarbonate CAS Number: 144-55-8 Other descriptive name: SODIUM BICARBONATE BP Concentration un

Eligibility

Sex/Gender

All

Inclusion criteria

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

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.

Design outcomes

Primary

Measure	Time frame
Main Objective: To evaluate the effect of nebulized bicarbonate on bacterial infections in the airway of patients with CF diagnosis.;Secondary Objective: - Analyze the pH variation of the airway after nebulized bicarbonate therapy. - To evaluate the cellular inflammatory changes that occur in the sputum, after nebulization with bicarbonate. - To compare the effect on bronchial obstruction of nebulized bicarbonate in the airway versus hypertonic saline solution 7% using the Leicester Cuestionario. - To compare the number of patients chronified at the end of the study, in both groups. - To compare the quality of life of patients in groups A and B. - Assess adherence to treatment by controlling the dispensing and the Morinsky-Green test. - Analyze possible adverse reactions.;Primary end point(s): Number of sputum cultures positive to Pseudomonas, taken at each follow-up visit during the year of study.;Timepoint(s) of evaluation of this end point: Every 8 weeks during 52 weeks	—

Measure

Time frame

Main Objective: To evaluate the effect of nebulized bicarbonate on bacterial infections in the airway of patients with CF diagnosis.;Secondary Objective: - Analyze the pH variation of the airway after nebulized bicarbonate therapy. - To evaluate the cellular inflammatory changes that occur in the sputum, after nebulization with bicarbonate. - To compare the effect on bronchial obstruction of nebulized bicarbonate in the airway versus hypertonic saline solution 7% using the Leicester Cuestionario. - To compare the number of patients chronified at the end of the study, in both groups. - To compare the quality of life of patients in groups A and B. - Assess adherence to treatment by controlling the dispensing and the Morinsky-Green test. - Analyze possible adverse reactions.;Primary end point(s): Number of sputum cultures positive to Pseudomonas, taken at each follow-up visit during the year of study.;Timepoint(s) of evaluation of this end point: Every 8 weeks during 52 weeks

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Secondary

Measure	Time frame
Secondary end point(s): - Number of sputum cultures positive for staphylococcus and other bacteria, mycobacteria and fungi, taken at each follow-up visit during the year of study. - Time between the start of the study and the first culture of positive sputum. - Changes in the pH of the airway fluid measured in the induced sputum in each visit compared to baseline - Changes in the quality of life test score in each visit compared to baseline - Changes from baseline in total lung volume by plethysmography at 12 months of treatment - Changes in the cellularity of the induced sputum in each of the visits - Leicester Cough Questionnaire on each visit - Adverse reactions - Morinsky adhesion test - Number of exacerbations per patient at end of study - Evolution with respect to baseline in FEV1 by spirometry in each of the study visits - Vitamin A, D, E levels, prothrombin time and thromboplastin time - Sobel test at 12 months of treatment - Radiological changes in the pulmonary parenchyma by pulmonary CT of low irradiation at 12 months of treatment;Timepoint(s) of evaluation of this end point: Every 2 months during 52 weeks	—

Measure

Time frame

Secondary end point(s): - Number of sputum cultures positive for staphylococcus and other bacteria, mycobacteria and fungi, taken at each follow-up visit during the year of study. - Time between the start of the study and the first culture of positive sputum. - Changes in the pH of the airway fluid measured in the induced sputum in each visit compared to baseline - Changes in the quality of life test score in each visit compared to baseline - Changes from baseline in total lung volume by plethysmography at 12 months of treatment - Changes in the cellularity of the induced sputum in each of the visits - Leicester Cough Questionnaire on each visit - Adverse reactions - Morinsky adhesion test - Number of exacerbations per patient at end of study - Evolution with respect to baseline in FEV1 by spirometry in each of the study visits - Vitamin A, D, E levels, prothrombin time and thromboplastin time - Sobel test at 12 months of treatment - Radiological changes in the pulmonary parenchyma by pulmonary CT of low irradiation at 12 months of treatment;Timepoint(s) of evaluation of this end point: Every 2 months during 52 weeks

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Countries

Spain

Contacts

Public ContactOficina de Recerca

Hospital Universitari Parc Tauli

afarre@tauli.cat34937458451

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026