BronchiectasisNCT04310618
Mucus Solids Concentration in Patients With Bronchiectasis
An observational study of Bronchiectasis, run by Universidad San Jorge at 1 site in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- How many people
- 36 participants
- Where
- 1 siteSpain
- Study dates
- 21 Dec 2020to Aug 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adults with bronchiectasis
Who may be able to join
- 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.
Who cannot join
- Current smoker or >10 pack-year history of tobacco use.
- Patient in transplantation or retransplantation list.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Marta San Miguel Pagola
Zaragoza, Aragon, 50014
Marta San Miguel Pagola, msanmiguelpagola@gmail.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Bronchiectasis
- Being tested
- No intervention
- Keywords
- Mucus concentration
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| Adults with bronchiectasis | Adult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inter-sample variability of sputum concentration (% solids)
% solids will be calculated by measuring the wet to dry sputum weight ratio
Measured: 2 stable weeks
Secondary outcomes (14)
Inter-sample variability of sputum concentration (% solids)
% solids will be calculated by measuring the wet to dry sputum weight ratio
Measured: 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
Measured: 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
Measured: 1 day
Forced expiratory volume at 1 second
Simple spirometry
Measured: Baseline
Forced vital capacity
Simple spirometry:
Measured: Baseline
Forced expiratory flow 25-75
Simple spirometry
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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".
Measured: 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".
Measured: During the first exacerbation after recruitment
Sputum colour
Sputum colour chart (Murray MP et al.)
Measured: Baseline
Sputum colour
Sputum colour chart (Murray MP et al.)
Measured: During the first exacerbation after recruitment
Exacerbation frequency
Number of exacerbations
Measured: 12 months before enrollement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2020
- Study start21 Dec 2020
- Primary completionMar 2023 (estimated)
- Study completionAug 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Prospective
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidad San Jorge
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Asociación Murciana de Fibrosis Quistica, University of North Carolina
- Responsible party
- Sponsor
- Investigators
- Marta San Miguel Pagola, Principal investigator, Universidad San Jorge
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04310618
- Sponsor's protocol ID
- wt%_S vs IN
- Other IDs
- Antonio Dupla Abadal 2018
- Status last verified
- Jan 2021
- First submitted
- 25 Feb 2020
- Last updated
- 1 Oct 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Characterization of Mucus Solids Concentration in Patients With Bronchiectasis: Cross-sectional Study
- ClinicalTrials.gov ID
- NCT04310618
- Acronym / sponsor ID
- wt%_S vs IN
- Conditions
- Bronchiectasis
- Keywords
- Mucus concentration
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Universidad San JorgeUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Asociación Murciana de Fibrosis Quistica, University of North Carolina
- Study start
- 21 Dec 2020 (actual)
- Primary completion
- Mar 2023 (estimated)
- Study completion
- Aug 2023 (estimated)
- First posted
- 17 Mar 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adults with bronchiectasis | – | Other: No interventionAdult subjets diagnosed with bronchiectasis by high-resolution computed tomography with symptomatology in stable phase |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adults with bronchiectasis
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (2 listed)
- Current smoker or >10 pack-year history of tobacco use.
- Patient in transplantation or retransplantation list.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| No interventionNo intervention | Other | Adults with bronchiectasis |
Primary outcome
Inter-sample variability of sputum concentration (% solids)
Time frame: 2 stable weeks
% solids will be calculated by measuring the wet to dry sputum weight ratio
14 secondary outcomes
Inter-sample variability of sputum concentration (% solids)
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
Time frame: 1 day
Sputum concentration (% solids) one month after the first exacerbation after recruitment
Time frame: 1 day
Forced expiratory volume at 1 second
Time frame: Baseline
Forced vital capacity
Time frame: Baseline
Forced expiratory flow 25-75
Time frame: Baseline
Quality of life related to cough
Time frame: Baseline
Impact of cough and sputum symptoms of everyday life
Time frame: Baseline
Breathlessness
Time frame: Baseline
Ease of coughing up
Time frame: Baseline
Ease of coughing up
Time frame: During the first exacerbation after recruitment
Sputum colour
Time frame: Baseline
Sputum colour
Time frame: During the first exacerbation after recruitment
Exacerbation frequency
Time frame: 12 months before enrollement
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2021.
- Sputum colour chart (Murray MP et al.)Link provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marta San Miguel Pagola principal investigator
Universidad San Jorge
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Bronchiectasis, run by Universidad San Jorge at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 1 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marta San Miguel Pagola, PhD (34617086431, msanmiguel@usj.es), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inter-sample variability of sputum concentration (% solids) (time frame: 2 stable weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2021.