BronchiectasisNCT04905992
Is a Single Daily Session Combining HS + Physio Sufficient to Obtain Long-term Clinical Benefits in Bronchiectasis?
A study testing Hypertonic saline at 6% and Airway clearance techniques (oscillating positive expiratory pressure therapy) in people with Bronchiectasis and Airway Clearance Impairment, run by Hospital Clínico Universitario Lozano Blesa at 2 sites in Spain.
Trial summary
The present study will aim to find out whether a home treatment in people with bronchiectasis consisting of a single daily session to facilitate expectoration (combining nebulization of hypertonic saline (HS) at 6% followed by airway clearance techniques) is at least as effective as performing two sessions per day… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis, Airway Clearance Impairment
- What is being tested?
- Hypertonic saline at 6% and Airway clearance techniques (oscillating positive expiratory pressure therapy)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 2 sitesSpain
- Study dates
- 1 Jul 2021to Dec 2023
- Phase
- Interventional
- 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
Who may be able to join
- 18 years or older
- a total score less than 16 on the Leicester Cough Questionnaire
- chronic daily expectoration over at least 3 months
- being in a period of clinical stability during the previous 4 weeks
- presenting a forced expiratory volume in 1 second (FEV1) value greater than 40% of predicted or >1 L
- obtaining informed consent.
- In addition, all participants will have had to satisfactorily pass the tolerability tests, which will be performed twice: i) on the first day; ii) and the following week.
Who cannot join
- having received nebulised mucoactive treatment during the previous year
- frequent haemoptysis (≥ 2 times/month)
- diagnosis or suspicion of cystic fibrosis by genetic study or sweat test
- being under active treatment for nontuberculous mycobacteria (NTM)
Trial locations and contacts
2 sites in 1 country.
Spain2 sites
Hospital Clinic
Barcelona
Beatriz Herrero Cortina
Zaragoza
Beatriz Herrero-Cortina
Beatriz Herrero-Cortina
About this study
Official title: Is a Single Daily Session Combining Hypertonic Saline Nebulisation and Airway Clearance Techniques Sufficient to Obtain Long-term Clinical Benefits in People With Bronchiectasis? A Randomised Non-inferiority Trial.
The present study will aim to find out whether a home treatment in people with bronchiectasis consisting of a single daily session to facilitate expectoration (combining nebulization of hypertonic saline (HS) at 6% followed by airway clearance techniques) is at least as effective as performing two sessions per day following the same process in each of the sessions, during a period of 6 months.
Read the detailed description
A non-inferiority randomised clinical trial (single-blind) will be conducted. At least 50 participants will be recruited from the outpatient clinics of the Hospital Clinic in Barcelona and the Clinical University Hospital in Zaragoza. The experimental group will nebulize once/day the hypertonic saline (HS) solution followed by airway clearance exercises (15 min) for 6 months. The control group will follow the same procedure, but the frequency of the sessions will be twice a day (reference as usual clinical practice). The main study outcomes will be: (1) cough severity (primary endpoint), symptoms and quality of life; (2) functional exercise capacity; (3) time to first exacerbation and total number of exacerbations; (4) indirect measures of mucociliary transport (rheology and concentration of solids in sputum samples); (5) inflammatory parameters; (5) tolerance, safety and adherence to treatment. Measurements will be taken at baseline (prior to randomization), at 1 month, 3 months, and 6 months. Finally, hypothesis testing will be performed using a linear mixed model (2x3) of repeated measures, establishing a priori a margin of non-inferiority.
- Conditions
- Bronchiectasis, Airway Clearance Impairment
- Being tested
- Hypertonic saline at 6%, Airway clearance techniques (oscillating positive expiratory pressure therapy)
- Keywords
- Airway clearance techniques, Hypertonic saline, Hyperosmolar agents, Oscillating positive expiratory pressure
- Medical subject headings
- Bronchiectasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypertonic saline at 6%Other
Participants will start the sessions by inhaling a short-acting bronchodilator or an anticholinergic to avoid the presence of bronchospasm during nebulisation. The hypertonic solution (at 6%) will be administered through the Turbo Boy nebuliser (Pari®). The intervention will take place at home.
Airway clearance techniques (oscillating positive expiratory pressure therapy)Other
Following nebulisation, participants will perform airway clearance techniques using an oscillating positive expiratory pressure device for at least 15 minutes. The intervention will take place at home
| Study group | Role | What they receive |
|---|---|---|
| Single daily session (Hypertonic saline + airway clearance techniques) | Experimental | The experimental group will perform a daily session at home including nebulisation of 5 mL of hypertonic saline (at 6%) followed by 15 min of airway clearance techniques (oscillating positive expiratory pressure therapy) for 6 months. Receives: Other: Hypertonic saline at 6%; Other: Airway clearance techniques (oscillating positive expiratory pressure therapy) |
| Twice daily session (Hypertonic saline + airway clearance techniques) | Active comparator | The control group will perform two daily sessions at home involving nebulisation of 5 mL of hypertonic saline (at 6%) followed by 15 min of airway clearance techniques (oscillating positive expiratory pressure therapy) for 6 months. Receives: Other: Hypertonic saline at 6%; Other: Airway clearance techniques (oscillating positive expiratory pressure therapy) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of coughing on quality of life
The Leicester Cough Questionnaire (LCQ) will be used to assess the daily cough impact
Measured: 6 months after starting the intervention
Secondary outcomes (8)
Impact of coughing on quality of life
The Leicester Cough Questionnaire (LCQ) will be used to assess the daily cough impact
Measured: Baseline point, 1 month and 3 months after starting the intervention
Disease-specific quality of life questionnaire
The Quality of life of Bronchiectasis (QoL-B) questionnaire will be used to evaluate the quality of life
Measured: Baseline point, 1 month, 3 months and 6 months after starting the intervention
Disease-specific symptoms questionnaire
The Bronchiectasis Impact Measure (BIM) outcome measure will be used to analyse the symptoms
Measured: Baseline point, 1 month, 3 months and 6 months after starting the intervention
Exercise capacity
The sit to stand test (1 minute) will be used to assess the exercise capacity
Measured: Baseline point, 1 month, 3 months and 6 months after starting the intervention
Exercise capacity
The six minute walk distance (6MWT) will be used to assess the exercise capacity
Measured: Baseline point
Exacerbations
The number of exacerbations, the severity of exacerbations (hospital admission) and the time to the first exacerbation will be recorded prospectively
Measured: From baseline point to the end of the intervention (6 months)
Biophysical properties of spontaneous sputum samples
Spontaneous sputum samples will be collected to analyse the main biophysical markers
Measured: Baseline point, 1 month, 3 months, 6 months
Inflammation markers (airway inflammation and systemic inflammation)
Blood and salivary samples will be collected to analyse the main inflammatory markers (neutrophil elastase, cytokines, peptides)
Measured: Baseline point, 1 month, 3 months, 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2021
- Study start1 Jul 2021 (estimated)
- Primary completionJun 2023 (estimated)
- Study completionDec 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A non-inferiority randomized clinical trial (single-blinded assessor).
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Clínico Universitario Lozano Blesa
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Universidad San Jorge
- Responsible party
- Principal investigator, Beatriz Herrero-Cortina, Hospital Clínico Universitario Lozano Blesa
- Investigators
- Victoria Alcaraz-Serrano, Principal investigator, Hospital Clinic of BarcelonaBeatriz Herrero-Cortina, Principal investigator, Hospital Clínico Universitario Lozano Blesa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04905992
- Sponsor's protocol ID
- HS_nonInferiority
- Status last verified
- Jun 2021
- First submitted
- 25 May 2021
- Last updated
- 18 Jun 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Is a Single Daily Session Combining Hypertonic Saline Nebulisation and Airway Clearance Techniques Sufficient to Obtain Long-term Clinical Benefits in People With Bronchiectasis? A Randomised Non-inferiority Trial.
- ClinicalTrials.gov ID
- NCT04905992
- Acronym / sponsor ID
- HS_nonInferiority
- Conditions
- Bronchiectasis, Airway Clearance Impairment
- Keywords
- Airway clearance techniques, Hypertonic saline, Hyperosmolar agents, Oscillating positive expiratory pressure
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Hospital Clínico Universitario Lozano BlesaUniversity, hospital or other
- Collaborators
- Hospital Clinic of Barcelona, Universidad San Jorge
- Study start
- 1 Jul 2021 (estimated)
- Primary completion
- Jun 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 28 May 2021 (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.
The present study will aim to find out whether a home treatment in people with bronchiectasis consisting of a single daily session to facilitate expectoration (combining nebulization of hypertonic saline (HS) at 6% followed by airway clearance techniques) is at least as effective as performing two sessions per day following the same process in each of the sessions, during a period of 6 months.
Detailed description
A non-inferiority randomised clinical trial (single-blind) will be conducted. At least 50 participants will be recruited from the outpatient clinics of the Hospital Clinic in Barcelona and the Clinical University Hospital in Zaragoza. The experimental group will nebulize once/day the hypertonic saline (HS) solution followed by airway clearance exercises (15 min) for 6 months. The control group will follow the same procedure, but the frequency of the sessions will be twice a day (reference as usual clinical practice). The main study outcomes will be: (1) cough severity (primary endpoint), symptoms and quality of life; (2) functional exercise capacity; (3) time to first exacerbation and total number of exacerbations; (4) indirect measures of mucociliary transport (rheology and concentration of solids in sputum samples); (5) inflammatory parameters; (5) tolerance, safety and adherence to treatment. Measurements will be taken at baseline (prior to randomization), at 1 month, 3 months, and 6 months. Finally, hypothesis testing will be performed using a linear mixed model (2x3) of repeated measures, establishing a priori a margin of non-inferiority.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- A non-inferiority randomized clinical trial (single-blinded assessor).
| Arm | Type | Receives |
|---|---|---|
| Single daily session (Hypertonic saline + airway clearance techniques) | Experimental | Other: Hypertonic saline at 6%, Other: Airway clearance techniques (oscillating positive expiratory pressure therapy)The experimental group will perform a daily session at home including nebulisation of 5 mL of hypertonic saline (at 6%) followed by 15 min of airway clearance techniques (oscillating positive expiratory pressure therapy) for 6 months. |
| Twice daily session (Hypertonic saline + airway clearance techniques) | Active comparator | Other: Hypertonic saline at 6%, Other: Airway clearance techniques (oscillating positive expiratory pressure therapy)The control group will perform two daily sessions at home involving nebulisation of 5 mL of hypertonic saline (at 6%) followed by 15 min of airway clearance techniques (oscillating positive expiratory pressure therapy) for 6 months. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18 years or older
- a total score less than 16 on the Leicester Cough Questionnaire
- chronic daily expectoration over at least 3 months
- being in a period of clinical stability during the previous 4 weeks
- presenting a forced expiratory volume in 1 second (FEV1) value greater than 40% of predicted or >1 L
Key exclusion criteria (4 listed)
- having received nebulised mucoactive treatment during the previous year
- frequent haemoptysis (≥ 2 times/month)
- diagnosis or suspicion of cystic fibrosis by genetic study or sweat test
- being under active treatment for nontuberculous mycobacteria (NTM)
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 |
|---|---|---|
| Hypertonic saline at 6%Participants will start the sessions by inhaling a short-acting bronchodilator or an anticholinergic to avoid the presence of bronchospasm during nebulisation. The hypertonic solution (at 6%) will be administered through the Turbo Boy nebuliser (Pari®). The intervention will take place at home. | Other | Single daily session (Hypertonic saline + airway clearance techniques), Twice daily session (Hypertonic saline + airway clearance techniques) |
| Airway clearance techniques (oscillating positive expiratory pressure therapy)Following nebulisation, participants will perform airway clearance techniques using an oscillating positive expiratory pressure device for at least 15 minutes. The intervention will take place at home | Other | Single daily session (Hypertonic saline + airway clearance techniques), Twice daily session (Hypertonic saline + airway clearance techniques) |
Primary outcome
Impact of coughing on quality of life
Time frame: 6 months after starting the intervention
The Leicester Cough Questionnaire (LCQ) will be used to assess the daily cough impact
8 secondary outcomes
Impact of coughing on quality of life
Time frame: Baseline point, 1 month and 3 months after starting the intervention
Disease-specific quality of life questionnaire
Time frame: Baseline point, 1 month, 3 months and 6 months after starting the intervention
Disease-specific symptoms questionnaire
Time frame: Baseline point, 1 month, 3 months and 6 months after starting the intervention
Exercise capacity
Time frame: Baseline point, 1 month, 3 months and 6 months after starting the intervention
Exercise capacity
Time frame: Baseline point
Exacerbations
Time frame: From baseline point to the end of the intervention (6 months)
Biophysical properties of spontaneous sputum samples
Time frame: Baseline point, 1 month, 3 months, 6 months
Inflammation markers (airway inflammation and systemic inflammation)
Time frame: Baseline point, 1 month, 3 months, 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2021.
- Individual participant dataSharing planned: No
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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.
Victoria Alcaraz-Serrano principal investigator
Hospital Clinic of Barcelona
Beatriz Herrero-Cortina principal investigator
Hospital Clínico Universitario Lozano Blesa
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic saline at 6% and Airway clearance techniques (oscillating positive expiratory pressure therapy) in people with Bronchiectasis and Airway Clearance Impairment, run by Hospital Clínico Universitario Lozano Blesa at 2 sites 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 7 inclusion and 4 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 18 Jun 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Beatriz Herrero-Cortina (34653051357, Beafisiorespi@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of coughing on quality of life (time frame: 6 months after starting the intervention). 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 18 Jun 2021.