Mucus Solids Concentration in Patients With Bronchiectasis

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Bronchiectasis
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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 2023

Primary Completion Date

March 2023

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 Clinic of Barcelona

Study Sponsor

Marta San Miguel Pagola, Principal Investigator, Universidad San Jorge

Verification Date

January 2021