Mucus Solids Concentration in Patients With Bronchiectasis

• Conditions: Bronchiectasis
• Interventions: Other: No intervention

• Registration Number: NCT04310618
• Lead Sponsor: Universidad San Jorge

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 Timeline

• Study First Submitted: 2020-02-25
• Study First Submitted QC: 2020-03-12
• Study First Posted: 2020-03-17
• Study Start: 2020-12-21
• Status Verified: 2021-01
• Last Update Submitted: 2021-09-30
• Last Update Posted: 2021-10-01
• Primary Completion: 2023-03
• Study Completion: 2023-08

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 36

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adults with bronchiectasis	No intervention	Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Inter-sample variability of sputum concentration (% solids)	1 stable day (at 9:00 am, 12:00 am and 17:00 pm)	% solids will be calculated by measuring the wet to dry sputum weight ratio
Forced expiratory flow 25-75	Baseline	Simple spirometry
Quality of life related to cough	Baseline	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.
Ease of coughing up	During the first exacerbation after recruitment	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".
Sputum colour	During the first exacerbation after recruitment	Sputum colour chart (Murray MP et al.)
Exacerbation frequency	12 months before enrollement	Number of exacerbations
Sputum concentration (% solids) during the first exacerbation after recruitment	1 day	% solids will be calculated by measuring the wet to dry sputum weight ratio
Impact of cough and sputum symptoms of everyday life	Baseline	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.
Breathlessness	Baseline	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.
Sputum concentration (% solids) one month after the first exacerbation after recruitment	1 day	% solids will be calculated by measuring the wet to dry sputum weight ratio
Forced expiratory volume at 1 second	Baseline	Simple spirometry
Forced vital capacity	Baseline	Simple spirometry:

Trial Locations

Locations (1)

Marta San Miguel Pagola; 🇪🇸 Zaragoza, Aragon, Spain