Mucus Solids Concentration in Patients With Bronchiectasis
Characterization of Mucus Solids Concentration in Patients With Bronchiectasis: Cross-sectional Study
2 other identifiers
observational
36
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Dec 2020
Typical duration for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 25, 2020
CompletedFirst Posted
Study publicly available on registry
March 17, 2020
CompletedStudy Start
First participant enrolled
December 21, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2023
CompletedOctober 1, 2021
January 1, 2021
2.2 years
February 25, 2020
September 30, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inter-sample variability of sputum concentration (% solids)
% solids will be calculated by measuring the wet to dry sputum weight ratio
2 stable weeks
Secondary Outcomes (14)
Inter-sample variability of sputum concentration (% solids)
1 stable day (at 9:00 am, 12:00 am and 17:00 pm)
Sputum concentration (% solids) during the first exacerbation after recruitment
1 day
Sputum concentration (% solids) one month after the first exacerbation after recruitment
1 day
Forced expiratory volume at 1 second
Baseline
Forced vital capacity
Baseline
- +9 more secondary outcomes
Study Arms (1)
Adults with bronchiectasis
Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase
Interventions
Eligibility Criteria
Adults with bronchiectasis
You may qualify if:
- 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.
You may not qualify if:
- Current smoker or \>10 pack-year history of tobacco use.
- Patient in transplantation or retransplantation list.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Universidad San Jorgelead
- Hospital Clinic of Barcelonacollaborator
- Asociación Murciana de Fibrosis Quisticacollaborator
- University of North Carolinacollaborator
Study Sites (1)
Marta San Miguel Pagola
Zaragoza, Aragon, 50014, Spain
Related Links
Biospecimen
Sputum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Marta San Miguel Pagola
Universidad San Jorge
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 25, 2020
First Posted
March 17, 2020
Study Start
December 21, 2020
Primary Completion
March 1, 2023
Study Completion
August 1, 2023
Last Updated
October 1, 2021
Record last verified: 2021-01