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Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis

Primary Purpose

Bronchiectasis

Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Hypertonic saline solution
Hyaneb solution
Isotonic saline solution
Sponsored by
Hospital Clinic of Barcelona
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Bronchiectasis focused on measuring Sputum clearance, Cough severity, Hypertonic saline, Acid hyaluronic, Tolerability

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Non-cystic Fibrosis bronchiectasis (NCFBE) diagnosed by High Resolution Computed Tomographic
  2. Mean sputum production ≥ 10 ml /24h.
  3. Clinical stability in the last 4 weeks
  4. To be able to understand how to perform inhalation and the physiotherapy session.
  5. To be able to provide written, informed consent

Exclusion Criteria:

  1. Forced expiratory volume in 1 second < 30% pred. ; Total lung capacity < 45% pred.
  2. Performing nebulization with any hyperosmolar agents, previously
  3. Allergic bronchopulmonary aspergillosis diagnosis
  4. 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)

Sites / Locations

  • Hospital Clinic

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

Hypertonic saline solution

Hyaneb solution

Isotonic saline solution

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Wet sputum production
Sputum collected during nebulization period and physiotherapy session

Secondary Outcome Measures

Wet sputum production
Spontaneous sputum expectorated during the following 24h after intervention
Impact on cough severity (Leicester Cough Questionnaire)
Self-administered questionnaire (Leicester Cough Questionnaire)
Lung function (Forced spirometry)
Forced spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75
Safety and tolerability (Adverse events)
Adverse events registration during the nebulization process (heart rate, saturation and dyspnoea)

Full Information

First Posted
March 13, 2015
Last Updated
November 11, 2016
Sponsor
Hospital Clinic of Barcelona
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1. Study Identification

Unique Protocol Identification Number
NCT02392663
Brief Title
Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis
Official Title
Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis: a Randomized, Double-blind, Crossover Trial
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
January 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital Clinic of Barcelona

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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). 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bronchiectasis
Keywords
Sputum clearance, Cough severity, Hypertonic saline, Acid hyaluronic, Tolerability

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
24 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Hypertonic saline solution
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Hyaneb solution
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Isotonic saline solution
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Hypertonic saline solution
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Hyaneb solution
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Isotonic saline solution
Intervention Description
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.
Primary Outcome Measure Information:
Title
Wet sputum production
Description
Sputum collected during nebulization period and physiotherapy session
Time Frame
1h wet sputum production (g)
Secondary Outcome Measure Information:
Title
Wet sputum production
Description
Spontaneous sputum expectorated during the following 24h after intervention
Time Frame
24h wet sputum production (g)
Title
Impact on cough severity (Leicester Cough Questionnaire)
Description
Self-administered questionnaire (Leicester Cough Questionnaire)
Time Frame
One week
Title
Lung function (Forced spirometry)
Description
Forced spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75
Time Frame
One week
Title
Safety and tolerability (Adverse events)
Description
Adverse events registration during the nebulization process (heart rate, saturation and dyspnoea)
Time Frame
20 minutes
Other Pre-specified Outcome Measures:
Title
Patients´preference (Likert test)
Description
Self-administered "Likert test" at the end of the trial
Time Frame
5 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eva Polverino, Dr.
Organizational Affiliation
Hospital Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital Clinic
City
Barcelona
ZIP/Postal Code
08036
Country
Spain

12. IPD Sharing Statement

Citations:
PubMed Identifier
32071136
Citation
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.
Results Reference
derived

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Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis

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