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Mucus Solids Concentration in Patients With Bronchiectasis

U

Universidad San Jorge

Status

Unknown

Conditions

Bronchiectasis

Treatments

Other: No intervention

Study type

Observational

Funder types

Other

Identifiers

NCT04310618
Antonio Dupla Abadal 2018 (Other Grant/Funding Number)
wt%_S vs IN

Details and patient eligibility

About

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.

Full 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.

Enrollment

36 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

36 participants in 1 patient group

Adults with bronchiectasis
Description:
Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase
Treatment:
Other: No intervention

Trial contacts and locations

1

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Central trial contact

Marta San Miguel Pagola, PhD

Data sourced from clinicaltrials.gov

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