BronchiectasisNCT02392663
Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis
A study testing Hypertonic saline solution, Hyaneb solution and Isotonic saline solution in people with Bronchiectasis, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial summary
This study aims to analyze whether the hypertonic saline nebulization enhances sputum clearance effects, reduces the impact on cough severity and their level of safety and tolerability in a population with non-cystic fibrosis bronchiectasis (NCFBE). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiectasis
- What is being tested?
- Hypertonic saline solution, Hyaneb solution and Isotonic saline solution
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 24 participants
- Where
- 1 siteSpain
- Study dates
- Mar 2015to Jan 2016
- 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
- Non-cystic Fibrosis bronchiectasis (NCFBE) diagnosed by High Resolution Computed Tomographic
- Mean sputum production ≥ 10 ml /24h.
- Clinical stability in the last 4 weeks
- To be able to understand how to perform inhalation and the physiotherapy session.
- To be able to provide written, informed consent
Who cannot join
- Forced expiratory volume in 1 second < 30% pred. ; Total lung capacity < 45% pred.
- Performing nebulization with any hyperosmolar agents, previously
- Allergic bronchopulmonary aspergillosis diagnosis
- Not to be able to overcome the safety test pre-intervention (oxygen saturation levels drop to < 90% and/or forced expiratory volume in 1 second decline more than < 12% from baseline during the nebulization process)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis: a Randomized, Double-blind, Crossover Trial
This study aims to analyze whether the hypertonic saline nebulization enhances sputum clearance effects, reduces the impact on cough severity and their level of safety and tolerability in a population with non-cystic fibrosis bronchiectasis (NCFBE). In addition, this trial aims to compare these health outcomes among 3 nebulized solutions: hypertonic saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%).
Read the detailed description
The present study will be a randomized, double-blind, crossover trial. Each nebulized solution [hypertonic saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%)] will be administrated during 4 days. After each inhalation, all patients will carry out a bronchial drainage session (autogenic drainage technique). All patients recruited will perform the three arms of intervention. In this way, each patient will be able to act as his/her own control.
A 7 days washout period will be required among the different solutions to avoid carryover effects.
During the study period the patients' pharmacological treatment remained unchanged.
- Conditions
- Bronchiectasis
- Being tested
- Hypertonic saline solution, Hyaneb solution, Isotonic saline solution
- Keywords
- Sputum clearance, Cough severity, Hypertonic saline, Acid hyaluronic, Tolerability
- 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 solutionOther
All patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation.
Hyaneb solutionOther
All patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation.
Isotonic saline solutionOther
All patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation.
| Study group | Role | What they receive |
|---|---|---|
| Hypertonic saline solution | Active comparator | Hypertonic saline (7%) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD).
Both patients and physiotherapist will be blind to the intervention. Receives: Other: Hypertonic saline solution |
| Hyaneb solution | Active comparator | Hyaneb (acid hyaluronic + hypertonic saline [7%]) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD).
Both patients and physiotherapist will be blind to the intervention. Receives: Other: Hyaneb solution |
| Isotonic saline solution | Placebo comparator | Isotonic saline (0,9%) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD).
Both patients and physiotherapist will be blind to the intervention. Receives: Other: Isotonic saline solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wet sputum production
Sputum collected during nebulization period and physiotherapy session
Measured: 1h wet sputum production (g)
Secondary outcomes (4)
Wet sputum production
Spontaneous sputum expectorated during the following 24h after intervention
Measured: 24h wet sputum production (g)
Impact on cough severity (Leicester Cough Questionnaire)
Self-administered questionnaire (Leicester Cough Questionnaire)
Measured: One week
Lung function (Forced spirometry)
Forced spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75
Measured: One week
Safety and tolerability (Adverse events)
Adverse events registration during the nebulization process (heart rate, saturation and dyspnoea)
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2015
- Study completionJan 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for BronchiectasisStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- 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
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eva Polverino, Hospital Clinic of Barcelona
- Investigators
- Eva Polverino, Dr., Principal investigator, Hospital Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02392663
- Sponsor's protocol ID
- Hyperosmolar_NCFB
- Status last verified
- Nov 2016
- First submitted
- 13 Mar 2015
- Last updated
- 15 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Herrero-Cortina B, Alcaraz-Serrano V, Torres A, Polverino E. Reliability and Minimum Important Difference of Sputum Weight in Bronchiectasis. Respir Care. 2020 Oct;65(10):1478-1487. doi: 10.4187/respcare.07175. Epub 2020 Feb 18.
PubMed 32071136
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis: a Randomized, Double-blind, Crossover Trial
- ClinicalTrials.gov ID
- NCT02392663
- Acronym / sponsor ID
- Hyperosmolar_NCFB
- Conditions
- Bronchiectasis
- Keywords
- Sputum clearance, Cough severity, Hypertonic saline, Acid hyaluronic, Tolerability
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2015 (actual)
- Study completion
- Jan 2016 (actual)
- First posted
- 19 Mar 2015 (estimated)
- 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.
This study aims to analyze whether the hypertonic saline nebulization enhances sputum clearance effects, reduces the impact on cough severity and their level of safety and tolerability in a population with non-cystic fibrosis bronchiectasis (NCFBE). In addition, this trial aims to compare these health outcomes among 3 nebulized solutions: hypertonic saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%).
Detailed description
The present study will be a randomized, double-blind, crossover trial. Each nebulized solution [hypertonic saline (7%); hyaluronic acid + hypertonic saline (7%); isotonic saline (0,9%)] will be administrated during 4 days. After each inhalation, all patients will carry out a bronchial drainage session (autogenic drainage technique). All patients recruited will perform the three arms of intervention. In this way, each patient will be able to act as his/her own control.
A 7 days washout period will be required among the different solutions to avoid carryover effects.
During the study period the patients' pharmacological treatment remained unchanged.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Hypertonic saline solution | Active comparator | Other: Hypertonic saline solutionHypertonic saline (7%) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD). Both patients and physiotherapist will be blind to the intervention. |
| Hyaneb solution | Active comparator | Other: Hyaneb solutionHyaneb (acid hyaluronic + hypertonic saline [7%]) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD). Both patients and physiotherapist will be blind to the intervention. |
| Isotonic saline solution | Placebo comparator | Other: Isotonic saline solutionIsotonic saline (0,9%) solution (5 ml) will be nebulized by all patients in a randomized order. Immediately after, patients will perform a bronchial drainage session. The airway clearance technique selected will be autogenic drainage (AD). Both patients and physiotherapist will be blind to the intervention. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Non-cystic Fibrosis bronchiectasis (NCFBE) diagnosed by High Resolution Computed Tomographic
- Mean sputum production ≥ 10 ml /24h.
- Clinical stability in the last 4 weeks
- To be able to understand how to perform inhalation and the physiotherapy session.
- To be able to provide written, informed consent
Key exclusion criteria (4 listed)
- Forced expiratory volume in 1 second < 30% pred. ; Total lung capacity < 45% pred.
- Performing nebulization with any hyperosmolar agents, previously
- Allergic bronchopulmonary aspergillosis diagnosis
- Not to be able to overcome the safety test pre-intervention (oxygen saturation levels drop to < 90% and/or forced expiratory volume in 1 second decline more than < 12% from baseline during the nebulization process)
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 solutionAll patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation. | Other | Hypertonic saline solution |
| Hyaneb solutionAll patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation. | Other | Hyaneb solution |
| Isotonic saline solutionAll patients will perform 4 sessions during the same week. Each session will be include: inhalation period + bronchial drainage period. 20 minutes will be spent to perform the inhalation period. Moreover, 30 minutes will be spent to complete the bronchial drainage session post-inhalation. | Other | Isotonic saline solution |
Primary outcome
Wet sputum production
Time frame: 1h wet sputum production (g)
Sputum collected during nebulization period and physiotherapy session
4 secondary outcomes
Wet sputum production
Time frame: 24h wet sputum production (g)
Impact on cough severity (Leicester Cough Questionnaire)
Time frame: One week
Lung function (Forced spirometry)
Time frame: One week
Safety and tolerability (Adverse events)
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Nov 2016.
- Derived from this study: PubMed 32071136Herrero-Cortina B, Alcaraz-Serrano V, Torres A, Polverino E. Reliability and Minimum Important Difference of Sputum Weight in Bronchiectasis. Respir Care. 2020 Oct;65(10):1478-1487. doi: 10.4187/respcare.07175. Epub 2020 Feb 18.
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Bronchiectasis
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.
Eva Polverino, Dr. principal investigator
Hospital Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypertonic saline solution, Hyaneb solution and Isotonic saline solution in people with Bronchiectasis, run by Hospital Clinic of Barcelona 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 5 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: finished, as of the sponsor's last update on 15 Nov 2016. 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. Some participants in this study may receive a placebo. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Wet sputum production (time frame: 1h wet sputum production (g)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02392663, which also lists 1 linked publication.
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 15 Nov 2016.