Clinical trial NCT04310618: Mucus Solids Concentration in Patients With Bronchiectasis
Official title: Characterization of Mucus Solids Concentration in Patients With Bronchiectasis: Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Bronchiectasis
Keywords: Mucus concentration
Lead sponsor: Universidad San Jorge
Sponsor class: OTHER
Collaborators: name: Hospital Clinic of Barcelona
name: Asociación Murciana de Fibrosis Quistica
name: University of North Carolina
First posted: 2020-03-17
Enrollment: 36
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adults with bronchiectasis

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.

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.

Primary outcomes:
measure: Inter-sample variability of sputum concentration (% solids)
timeFrame: 2 stable weeks
Secondary outcomes:
measure: Inter-sample variability of sputum concentration (% solids)
timeFrame: 1 stable day (at 9:00 am, 12:00 am and 17:00 pm)
measure: Sputum concentration (% solids) during the first exacerbation after recruitment
timeFrame: 1 day
measure: Sputum concentration (% solids) one month after the first exacerbation after recruitment
timeFrame: 1 day
measure: Forced expiratory volume at 1 second
timeFrame: Baseline
measure: Forced vital capacity
timeFrame: Baseline
measure: Forced expiratory flow 25-75
timeFrame: Baseline
measure: Quality of life related to cough
timeFrame: Baseline
measure: Impact of cough and sputum symptoms of everyday life
timeFrame: Baseline
measure: Breathlessness
timeFrame: Baseline
measure: Ease of coughing up
timeFrame: Baseline
measure: Ease of coughing up
timeFrame: During the first exacerbation after recruitment
measure: Sputum colour
timeFrame: Baseline
measure: Sputum colour
timeFrame: During the first exacerbation after recruitment
measure: Exacerbation frequency
timeFrame: 12 months before enrollement
Other outcomes:
Locations:
city: Zaragoza
country: Spain
facility: Marta San Miguel Pagola
state: Aragon
Study officials:
affiliation: Universidad San Jorge
name: Marta San Miguel Pagola
role: PRINCIPAL_INVESTIGATOR
References: