Overview
Sponsor-declared trial summary
Adult bronchiectasis
To evaluate if patients with chronic bronchial infection after receiving a course of targeted oral or intravenous treatment who subsequently receive treatment with inhaled antibiotics have a reduction in the colony-forming units compared to the placebo group.
Key facts
- Sponsor
- Consorci Mar Parc De Salut De Barcelona
- Participant type
- Patients
- Age range
- 18-64 years, 65+ years
- Gender
- Male and Female
- Therapeutic area
- Diseases [C] - Respiratory Tract Diseases [C08]
- Decision date (initial)
- 2024-06-03
- Transition trial
- No
- Low-intervention
- Yes
- Rare-disease indication
- No
- Vulnerable population
- No
Trial design
CTIS Part I — objectives, methods, condition coding
Main objective
Scope: Therapy
To evaluate if patients with chronic bronchial infection after receiving a course of targeted oral or intravenous treatment who subsequently receive treatment with inhaled antibiotics have a reduction in the colony-forming units compared to the placebo group.
Conditions and MedDRA coding
Adult bronchiectasis
Eligibility criteria
Principal inclusion / exclusion criteria as submitted by sponsor
Inclusion criteria 9
- Adult patients with bronchiectasis.
- Age 20 to 90 years
- Men and women alike.
- Minimum of 2 sputum cultures positive for the same germ in the last year.
- Under follow-up by the Multidisciplinary Bronchiectasis Unit of Hospital del Mar.
- Severity of bronchiectasis and exacerbations according to the current scales: BSI, FACED, EFACED.
- 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.
- Provide signed and dated informed consent form.
- Be willing to comply with all study procedures and be available during the duration of the study.
Exclusion criteria 6
- Inhaled/nebulized antibiotic therapy in the last year
- Adverse reactions to inhaled/nebulized antibiotics
- Inability to use the nebulization device
- Carriers of chronic home oxygen therapy
- Concomitant infection with nontuberculous mycobacteria
- In the case of women of childbearing age, a positive pregnancy test or desire for pregnancy during the period of the study
Endpoints
Primary and secondary outcome measures (English text)
Primary endpoints 1
- Number of colony forming units (CFU)
Investigational products
Investigational medicinal products (IMPs), comparators, placebo, auxiliary
Test 2
SUB06801MIG · Substance
- Active substance
- Colistimethate Sodium
- Pharmaceutical form
- NEBULISER SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 4000000 IU international unit(s)
- Max total dose
- 4000000 IU international unit(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
SUB11134MIG · Substance
- Active substance
- Tobramycin
- Pharmaceutical form
- NEBULISER SOLUTION
- Route of administration
- INHALATION
- Max daily dose
- 600 mg milligram(s)
- Max total dose
- 600 mg milligram(s)
- Max treatment duration
- 48 Week(s)
- Authorisation status
- Authorised
- ATC code
- - — -
- Marketing authorisation
- -
- Paediatric formulation
- No
- Orphan designation
- No
- Modified vs. Marketing Authorisation
- No
Placebo 1
Suero Fisiológico Braun 0,9% disolvente para uso parenteral Cloruro de sodio.
N/A · Product
- Other product name
- N/A
- Pharmaceutical form
- N/A
- ATC code
- N/A — N/A
- Marketing authorisation
- N/A
- MA holder
- N/A
- MA country
- Iceland
- Paediatric formulation
- No
Sponsors and contacts
Sponsor organisations, regulatory contacts, third parties
Consorci Mar Parc De Salut De Barcelona
- Sponsor organisation
- Consorci Mar Parc De Salut De Barcelona
- Address
- Passeig Maritim De La Barceloneta 25-29
- City
- Barcelona
- Postcode
- 08003
- Country
- Spain
Scientific contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Ana Maria Aldea
Public contact point
- Organisation
- Consorci Mar Parc De Salut De Barcelona
- Contact name
- Ana Maria Aldea
Locations
1 EU/EEA country · 1 investigational sites
By country
| Country | MS status | Planned subjects | Sites |
|---|---|---|---|
| Spain | Authorised, recruitment pending | 75 | 1 |
| Rest of world | — | 0 | — |
Investigational sites
Application history
1 submissions — initial application plus substantial / non-substantial modifications
| # | Type | Code | Submitted | Reference MS | Conclusion | Decision date |
|---|---|---|---|---|---|---|
| 1 | INITIAL | IN | 2024-03-04 | Spain | Acceptable 2024-06-03
|
2024-06-03 |