An observational study in Bronchiectasis, sponsored by Universidad San Jorge. Status unknown at 1 site in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-10-01.
Sponsored by Universidad San Jorge · Observational
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.
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.
368 studies on the registry are indexed under Bronchiectasis; 104 are open to participants now.
This study's planned enrollment of 36 is below the median of 160 across 132 observational studies indexed under Bronchiectasis.
Browse Bronchiectasis studies →Universidad San Jorge is the lead sponsor of 32 studies on the registry; 4 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Adults with bronchiectasis
Exclusion Criteria:
Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase
Other: No intervention
No intervention
Inter-sample variability of sputum concentration (% solids)
% solids will be calculated by measuring the wet to dry sputum weight ratio
Time frame: 2 stable weeks
Inter-sample variability of sputum concentration (% solids)
% solids will be calculated by measuring the wet to dry sputum weight ratio
Time frame: 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
Time frame: 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
Time frame: 1 day
Forced expiratory volume at 1 second
Simple spirometry
Time frame: Baseline
Forced vital capacity
Simple spirometry:
Time frame: Baseline
Forced expiratory flow 25-75
Simple spirometry
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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".
Time frame: 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".
Time frame: During the first exacerbation after recruitment
Sputum colour
Sputum colour chart (Murray MP et al.)
Time frame: Baseline
Sputum colour
Sputum colour chart (Murray MP et al.)
Time frame: During the first exacerbation after recruitment
Exacerbation frequency
Number of exacerbations
Time frame: 12 months before enrollement
This study is status unknown, as verified in Jan 2021. You cannot join it, but the record below documents what was studied.
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Universidad San Jorge