Bronchiectasis
Conditions
Keywords
Mucus concentration
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.
Interventions
OTHERNo intervention
No intervention
Sponsors
Hospital Clinic of Barcelona
Asociación Murciana de Fibrosis Quistica
University of North Carolina
Universidad San Jorge
Study design
Observational model
OTHER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inter-sample variability of sputum concentration (% solids) | 2 stable weeks | % solids will be calculated by measuring the wet to dry sputum weight ratio |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Sputum concentration (% solids) during the first exacerbation after recruitment | 1 day | % solids will be calculated by measuring the wet to dry sputum weight ratio |
| 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: |
| 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. |
| 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. |
| Ease of coughing up | Baseline | 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 | Baseline | Sputum colour chart (Murray MP et al.) |
| Exacerbation frequency | 12 months before enrollement | Number of exacerbations |
Countries
Spain
Contacts
Primary ContactMarta San Miguel Pagola, PhD
Outcome results
None listed