Safety and efficacy of inhaled bicarbonate solution in patients with cystic fibrosis

Safety and efficacy of the inhalation of bicarbonate in patients with cystic fibrosis - RCMM2015

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2015-000513-48-IT

Enrollment

Registered

2016-09-12

Start date

Unknown

Completion date

Unknown

Last updated

2025-01-27

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

Conditions

Cystic Fibrosis MedDRA version: 19.0 Level: LLT Classification code 10006222 Term: Breast cystic fibrosis System Organ Class: 100000004872

Interventions

Trade Name: SODIO BICARBONATO S.A.L.F. - 10 MEQ/10 ML CONCENTRATO PER SOLUZIONE PER INFUSIONE 5 FIALE 10 ML Product Name: sodio bicarbonato Pharmaceutical Form: Concentrate for solution for infusion I

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Written informed consent signed • Age = 6 years • Ability to expectorate and meet all the requirements of the Protocol • Ability to perform pulmonary function tests and the absence of contraindications execution Are the trial subjects under 18? yes Number of subjects for this age range: 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: 1. episode of hemoptysis in the 48 hours prior to administration of the drug provided by the study . • 2. Demonstrated local or systemic hypersensitivity to bicarbonate • 3. Signs and symptoms of acute lung disease requiring oxygen therapy • 4. Other important clinical conditions detected during screening , which may interfere with the feedback of the studio.

Design outcomes

Primary

Measure	Time frame
Main Objective: Evaluate safety and tolerability of a single inhalation of saline solution containing a high concentration of sodium bicarbonate ( 500mm);Secondary Objective: Quantitatively assess changes in the viscosity of the mucus in patients with cystic fibrosis and the effects on bacteria;Primary end point(s): absence of adverse events assessed within 1 hour inhalation;Timepoint(s) of evaluation of this end point: 5 min, 30 min, 60 min	—

Measure

Time frame

Main Objective: Evaluate safety and tolerability of a single inhalation of saline solution containing a high concentration of sodium bicarbonate ( 500mm);Secondary Objective: Quantitatively assess changes in the viscosity of the mucus in patients with cystic fibrosis and the effects on bacteria;Primary end point(s): absence of adverse events assessed within 1 hour inhalation;Timepoint(s) of evaluation of this end point: 5 min, 30 min, 60 min

—

Secondary

Measure	Time frame
Secondary end point(s): Decrease in mucus viscosity of at least 20% Decrease in bacterial colonies by at least 50 %;Timepoint(s) of evaluation of this end point: before inhalation (t 0 ) , after 30 min by inhaling , after 60 min by inhaling	—

Countries

Italy

Contacts

Public ContactUOSD Epidemiologia, biostatistica e

IRCCS G.Gaslini

comitatoetico@ospedale-gaslini.ge.it01056363462

Outcome results

None listed

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