Clinical trial • Phase IV • Respiratory
COLISTIMETHATE SODIUM for Bronchiectasis
Phase IV trial of COLISTIMETHATE SODIUM for Bronchiectasis.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Bronchiectasis
- Trial Stage
- Phase IV
- Drug Modality
- Small molecule
Key dates
- Initial CTIS Submission Date
- 04-03-2024
- First CTIS Authorization Date
- 03-06-2024
Trial design
Placebo: Suero Fisiológico Braun 0,9% (saline). Test products: COLISTIMETHATE SODIUM (nebuliser solution) and TOBRAMYCIN (nebuliser solution). Reported maximum daily doses: Colistimethate sodium 4,000,000 IU, Tobramycin 600 mg. Route: inhalation. Detailed dose schedule not specified in the provided data.-controlled Phase IV trial across 1 site in Spain.
- Comparator
- Placebo: Suero Fisiológico Braun 0,9% (saline). Test products: COLISTIMETHATE SODIUM (nebuliser solution) and TOBRAMYCIN (nebuliser solution). Reported maximum daily doses: Colistimethate sodium 4,000,000 IU, Tobramycin 600 mg. Route: inhalation. Detailed dose schedule not specified in the provided data.
- Target Sample Size
- 75
- Trial Duration For Participant
- 48
Eligibility
Recruits 75 No vulnerable populations selected. Informed consent required: 'Provide signed and dated informed consent form.' Consent provided by the adult participant. No assent or paediatric consent process described; languages not specified..
- Pregnancy Exclusion
- In the case of women of childbearing age, a positive pregnancy test or desire for pregnancy during the period of the study
- Vulnerable Population
- No vulnerable populations selected. Informed consent required: 'Provide signed and dated informed consent form.' Consent provided by the adult participant. No assent or paediatric consent process described; languages not specified.
Inclusion criteria
- {"criterion_text":"- Adult patients with bronchiectasis."}
- {"criterion_text":"- Age 20 to 90 years"}
- {"criterion_text":"- Men and women alike."}
- {"criterion_text":"- Minimum of 2 sputum cultures positive for the same germ in the last year."}
- {"criterion_text":"- Under follow-up by the Multidisciplinary Bronchiectasis Unit of Hospital del Mar."}
- {"criterion_text":"- Severity of bronchiectasis and exacerbations according to the current scales: BSI, FACED, EFACED."}
- {"criterion_text":"- All patients who meet these criteria will be included regardless of their background treatment: Inhaled corticosteroids, bronchodilators, concomitant treatment with oral antibiotics such as azithromycin and whether or not they are receiving respiratory physiotherapy."}
- {"criterion_text":"- Provide signed and dated informed consent form."}
- {"criterion_text":"- Be willing to comply with all study procedures and be available during the duration of the study."}
Exclusion criteria
- {"criterion_text":"- Inhaled/nebulized antibiotic therapy in the last year"}
- {"criterion_text":"- Adverse reactions to inhaled/nebulized antibiotics"}
- {"criterion_text":"- Inability to use the nebulization device"}
- {"criterion_text":"- Carriers of chronic home oxygen therapy"}
- {"criterion_text":"- Concomitant infection with nontuberculous mycobacteria"}
- {"criterion_text":"- In the case of women of childbearing age, a positive pregnancy test or desire for pregnancy during the period of the study"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Number of colony forming units (CFU)","definition_or_measurement_approach":"Evaluate reduction in colony-forming units (CFU) after treatment compared to placebo (as stated in main objective); no further measurement details provided."}
Recruitment
- Planned Sample Size
- 75
- Recruitment Window Months
- 22
- Consent Approach
- Written informed consent required: 'Provide signed and dated informed consent form.' Consent provided by the adult participant. No paediatric assent/consent procedures or languages specified.
Geography
- Total Number Of Sites
- 1
- Total Number Of Participants
- 75
Spain
- Earliest CTIS Part Ii Submission Date
- 24-05-2024
- Latest Decision Or Authorization Date
- 03-06-2024
- Processing Time Days
- 10
- Number Of Sites
- 1
- Number Of Participants
- 75
Sites
- Site Name
- Consorci Mar Parc De Salut De Barcelona
- Department Name
- Pulmonology
- Contact Person Name
- Esther Barreiro
- Contact Person Email
- recerca@imim.es
- Number Of Participants
- 75
Sponsor
Primary sponsor
- Full Name
- Consorci Mar Parc De Salut De Barcelona
- Organisation Type
- Hospital/Clinic/Other health care facility
- Country Of Registered Address
- Spain
Investigational products
- Investigational Product Name
- COLISTIMETHATE SODIUM
- Active Substance
- COLISTIMETHATE SODIUM
- Modality
- Small molecule
- Routes Of Administration
- Inhalation
- Route
- Inhalation
- Authorisation Status
- Authorised (prodAuthStatus 2)
- Maximum Dose
- 4000000 IU
- Investigational Product Name
- TOBRAMYCIN
- Active Substance
- TOBRAMYCIN
- Modality
- Small molecule
- Routes Of Administration
- Inhalation
- Route
- Inhalation
- Authorisation Status
- Authorised (prodAuthStatus 2)
- Maximum Dose
- 600 mg
- Investigational Product Name
- Suero Fisiológico Braun 0,9% disolvente para uso parenteral Cloruro de sodio.
- Modality
- Other
- Combination Treatment
- Yes
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