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

• Register: EUCTR
• Last refreshed on: 23 October 2023
• Main ID: EUCTR2016-004033-25-ES
• Date of registration: 31/03/2017
• Prospective Registration: Yes
• Primary sponsor: Fundació Parc Taulí
• Public title: Randomized clinical trial to assess the effect of nebulizad bicarbonate on bacterial infections in patients with cystic fibrosis
• Scientific title: Efect of nebulized bicarbonate on bacterial infections in patients with cystic fibrosis. Randomized clinical trial
• Date of first enrolment: 19/06/2017
• Target sample size: 70
• Recruitment status: Not Recruiting
• URL: https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2016-004033-25
• Study type: Interventional clinical trial of medicinal product
• Study design: Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: yes Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: no Placebo: yes Other: no Number of treatment arms in the trial: 2
• Phase: Human pharmacology (Phase I): no Therapeutic exploratory (Phase II): yes Therapeutic confirmatory - (Phase III): no Therapeutic use (Phase IV): no

Countries of recruitment

Spain

Contacts

• Name: Oficina de Recerca
• Affiliation: Hospital Universitari Parc Tauli

• Name: Oficina de Recerca
• Affiliation: Hospital Universitari Parc Tauli

Key inclusion & exclusion 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:
- 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.


Age minimum:
Age maximum:
Gender:
Female: yes
Male: yes

Health Condition(s) or Problem(s) studied

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

Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Intervention(s)

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 unit: mol/l mole(s)/litre
Concentration type: equal
Concentration number: 1-
Pharmaceutical form of the placebo: Solution for injection
Route of administration of the placebo: Inhalation use

Product Name: sodium chloride
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Sodium chloride
CAS Number: 7647-14-5
Other descriptive name: SODIUM CHLORIDE
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Concentration number: 0.2-

Product Name: sodium chloride
Pharmaceutical Form: Concentrate for solution for injection
INN or Proposed INN: Sodium chloride
CAS Number: 7647-14-5
Other descriptive name: SODIUM CHLORIDE
Concentration unit: g/ml gram(s)/millilitre
Concentration type: equal
Concentration number: 0.2-

Product Name: Water for injections
Pharmaceutical Form: Solvent for parenteral use
INN or Proposed INN: water for injections
CAS Number: 7789-20-0
Other descriptive name: WATER FOR INJECTIONS, EP
Concentration unit: ml millilitre(s)
Concentration type: equal
Concentration number: 10-

Primary Outcome(s)

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.

Main Objective: To evaluate the effect of nebulized bicarbonate on bacterial infections in the airway of patients with CF diagnosis.

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

Secondary Outcome(s)

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

Secondary ID(s)

PED-FQ-2016

Source(s) of Monetary Support

Fundació Parc Taulí

Ethics review

Status: Approved
Approval date: 11/04/2017
Contact: