Mucus Solids Concentration in Patients With Bronchiectasis

Characterization of Mucus Solids Concentration in Patients With Bronchiectasis: Cross-sectional Study

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.

Study Overview

• Status: Recruiting
• Conditions: Bronchiectasis
• Intervention / Treatment: Other: No intervention

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
• Enrollment (Anticipated): 36

Contacts and Locations

• Study Contact: Name: Marta San Miguel Pagola, PhD; Phone Number: 34617086431; Email: msanmiguel@usj.es

Study Locations

• Spain
  • Aragon
    • Zaragoza, Aragon, Spain, 50014
      • Recruiting
      • Marta San Miguel Pagola
      • Contact: Marta San Miguel Pagola; Email: msanmiguelpagola@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Adults with bronchiectasis

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Adults with bronchiectasis; Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase	Other: No intervention; No intervention

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-sample variability of sputum concentration (% solids)	% solids will be calculated by measuring the wet to dry sputum weight ratio	2 stable weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inter-sample variability of sputum concentration (% solids)	% solids will be calculated by measuring the wet to dry sputum weight ratio	1 stable day (at 9:00 am, 12:00 am and 17:00 pm)
Sputum concentration (% solids) during the first exacerbation after recruitment	% solids will be calculated by measuring the wet to dry sputum weight ratio	1 day
Sputum concentration (% solids) one month after the first exacerbation after recruitment	% solids will be calculated by measuring the wet to dry sputum weight ratio	1 day
Forced expiratory volume at 1 second	Simple spirometry	Baseline
Forced vital capacity	Simple spirometry:	Baseline
Forced expiratory flow 25-75	Simple spirometry	Baseline
Quality of life related to cough	Leicester Cough Questionnaire (LCQ). Self-administered questionnaire that evaluates the impact of cough in three domains: physical, psychological, and social (each one ranged 1 to 7). It is composed of 19 questions and the "total score (range 3 to 21) is calculated by adding the domain scores together". The lower the score, the greater the severity.	Baseline
Impact of cough and sputum symptoms of everyday life	Cough and Sputum Assessment Questionnaire (CASA-Q). Self-administered questionnaire that consists of 20 questions organized in four domains (cough symptoms, cough impact, sputum symptoms, and sputum impact). Each domain is ranged from 0 to 100. The total score is expressed over 100 and calculated doing an average of the four domains. The lower the score, the greater the severity.	Baseline
Breathlessness	Modified Medical Research Council breathlessness scale: self-rating tool to measure the degree of disability that breathlessness poses on day-to-day activities on a scale from 0 to 4: 0, no breathlessness except on strenuous exercise; 1, shortness of breath when hurrying on the level or walking up a slight hill; 2, walks slower than people of same age on the level because of breathlessness or has to stop to catch breath when walking at their own pace on the level; 3, stops for breath after walking ∼100 m or after few minutes on the level; and 4, too breathless to leave the house, or breathless when dressing or undressing.	Baseline
Ease of coughing up	Visual analog scales are 10-cm lines anchored at the ends by words that define the bounds of ease of coughing up options; corresponding 0 to "expectorate is very easy" and 10 to "expectorate is very difficult".	Baseline
Ease of coughing up	Visual analog scales are 10-cm lines anchored at the ends by words that define the bounds of ease of coughing up options; corresponding 0 to "expectorate is very easy" and 10 to "expectorate is very difficult".	During the first exacerbation after recruitment
Sputum colour	Sputum colour chart (Murray MP et al.)	Baseline
Sputum colour	Sputum colour chart (Murray MP et al.)	During the first exacerbation after recruitment
Exacerbation frequency	Number of exacerbations	12 months before enrollement

Collaborators and Investigators

• Sponsor: Universidad San Jorge
• Collaborators: Hospital Clinic of Barcelona; University of North Carolina; Asociación Murciana de Fibrosis Quistica
• Investigators: Principal Investigator: Marta San Miguel Pagola, Universidad San Jorge

Publications and helpful links

Helpful Links

• Sputum colour chart (Murray MP et al.)

Study record dates

Study Major Dates

• Study Start (Actual): December 21, 2020
• Primary Completion (Anticipated): March 1, 2023
• Study Completion (Anticipated): August 1, 2023

Study Registration Dates

• First Submitted: February 25, 2020
• First Submitted That Met QC Criteria: March 12, 2020
• First Posted (Actual): March 17, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 30, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: Mucus concentration
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Bronchial Diseases; Bronchiectasis
• Other Study ID Numbers: wt%_S vs IN; Antonio Dupla Abadal 2018 (Other Grant/Funding Number: Sociedad Aragonesa de Aparato Respiratorio (SADAR))

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No