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

INTERVENTION: 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‐ CONDITION: 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] PRIMARY OUTCOME: 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. 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. Timepoint(s) of evaluation of this end point: Every 8 weeks during 52 weeks 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 SECONDARY OUTCOME: 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