Mucus Solids Concentration in Patients With Bronchiectasis

Bronchiectasis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04310618
• Other study ID #: wt%_S vs IN
• Secondary ID: Antonio Dupla Ab
• Status: Recruiting
• Start date: December 21, 2020
• Est. completion date: August 2023

Study information

• Verified date: January 2021
• Source: Universidad San Jorge
• Contact: Marta San Miguel Pagola, PhD
• Phone: 34617086431
• Email: msanmiguel[@]usj.es
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 36
• Est. completion date: August 2023
• Est. primary completion date: March 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Other:
• No intervention
No intervention

Locations

Country	Name	City	State
Spain	Marta San Miguel Pagola	Zaragoza	Aragon

Sponsors (4)

Lead Sponsor	Collaborator
Universidad San Jorge	Asociación Murciana de Fibrosis Quistica, Hospital Clinic of Barcelona, University of North Carolina

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Inter-sample variability of sputum concentration (% solids)	% solids will be calculated by measuring the wet to dry sputum weight ratio	2 stable weeks
Secondary	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)
Secondary	Sputum concentration (% solids) during the first exacerbation after recruitment	% solids will be calculated by measuring the wet to dry sputum weight ratio	1 day
Secondary	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
Secondary	Forced expiratory volume at 1 second	Simple spirometry	Baseline
Secondary	Forced vital capacity	Simple spirometry:	Baseline
Secondary	Forced expiratory flow 25-75	Simple spirometry	Baseline
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Sputum colour	Sputum colour chart (Murray MP et al.)	Baseline
Secondary	Sputum colour	Sputum colour chart (Murray MP et al.)	During the first exacerbation after recruitment
Secondary	Exacerbation frequency	Number of exacerbations	12 months before enrollement

External Links

•   Sputum colour chart (Murray MP et al.)