Brief Title
Mucus Solids Concentration in Patients With Bronchiectasis
Official Title
Characterization of Mucus Solids Concentration in Patients With Bronchiectasis: Cross-sectional Study
Brief Summary
There is a need for biomarkers that can rapidly and sensitively detect therapeutic benefits of therapies designed to "rehydrate" airways and monitor disease severity and progression. In this study the investigators will evaluate the stability of mucus concentration in patients with bronquiectasis (CF and NCBF) and its ability to respond to acute exacerbations in order to assess whether it can be a good candidate for biomarker.
Detailed Description
Prospective cross-sectional study of repeated measurements. The recruitment will be performed in 3 different cities of Spain: Zaragoza, Barcelona and Murcia. Subjects will be asked to repeatedly collect spontaneous and induced sputum samples in both stable and exacerbated conditions. All samples will be collected autonomously by patients in their homes after they have been instructed and supervised. Hypertonic saline nebulization will be used for sputum induction.
Study Type
Observational
Primary Outcome
Inter-sample variability of sputum concentration (% solids)
Secondary Outcome
Inter-sample variability of sputum concentration (% solids)
Condition
Bronchiectasis
Intervention
No intervention
Study Arms / Comparison Groups
Adults with bronchiectasis
Description: Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
36
Start Date
December 21, 2020
Completion Date
August 2021
Primary Completion Date
March 2021
Eligibility Criteria
Inclusion Criteria: - Confirmed diagnosis of CF (confirmed genetics) or diagnosis of non-CF bronchiectasis through high resolution computed tomography. - Aged ≥ 18 years. - Clinically stable at the time of recruitment. - Chronic sputum production (able to produce spontaneous sputum daily). - Current hypertonic saline user. - Able to provide written informed consent and perform the trial. Exclusion Criteria: - Current smoker or >10 pack-year history of tobacco use. - Patient in transplantation or retransplantation list.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Marta San Miguel Pagola, 34617086431, [email protected]
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT04310618
Organization ID
wt%_S vs IN
Secondary IDs
Antonio Dupla Abadal 2018
Responsible Party
Sponsor
Study Sponsor
Universidad San Jorge
Collaborators
Hospital Clínic de Barcelona
Study Sponsor
Marta San Miguel Pagola, Principal Investigator, Universidad San Jorge
Verification Date
January 2021