Mucus Solids Concentration in Patients With Bronchiectasis

NCT ID: NCT04310618

Last Updated: 2021-10-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

36 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-21

Study Completion Date

2023-08-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Bronchiectasis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Adults with bronchiectasis

Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase

No intervention

Intervention Type OTHER

No intervention

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

No intervention

No intervention

Intervention Type OTHER

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hospital Clinic of Barcelona

OTHER

Sponsor Role collaborator

Asociación Murciana de Fibrosis Quistica

UNKNOWN

Sponsor Role collaborator

University of North Carolina

OTHER

Sponsor Role collaborator

Universidad San Jorge

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Marta San Miguel Pagola

Role: PRINCIPAL_INVESTIGATOR

Universidad San Jorge

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Marta San Miguel Pagola

Zaragoza, Aragon, Spain

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

Spain

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Marta San Miguel Pagola, PhD

Role: CONTACT

34617086431

Facility Contacts

Find local site contact details for specific facilities participating in the trial.

Marta San Miguel Pagola

Role: primary

Related Links

Access external resources that provide additional context or updates about the study.

https://www.ncbi.nlm.nih.gov/pubmed/19648517

Sputum colour chart (Murray MP et al.)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

Antonio Dupla Abadal 2018

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

wt%_S vs IN

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Bronchial Asthma & Its Exacerbation
NCT06331897 NOT_YET_RECRUITING