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NCT02392663

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

NCT ID: NCT02392663

Last Updated: 2016-11-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

24 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-03-31

Study Completion Date

2016-01-31

Brief Summary

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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

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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

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Bronchiectasis

Keywords

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Sputum clearance Cough severity Hypertonic saline Acid hyaluronic Tolerability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Hypertonic saline solution

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.

Group Type ACTIVE_COMPARATOR

Hypertonic saline solution

Intervention Type OTHER

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 solution

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.

Group Type ACTIVE_COMPARATOR

Hyaneb solution

Intervention Type OTHER

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 solution

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.

Group Type PLACEBO_COMPARATOR

Isotonic saline solution

Intervention Type OTHER

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.

Interventions

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Hypertonic saline solution

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

Hyaneb solution

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

Isotonic saline solution

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

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hospital Clinic of Barcelona

OTHER

Sponsor Role lead

Responsible Party

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Eva Polverino

Post doctoral investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eva Polverino, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hospital Clinic

Locations

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Hospital Clinic

Barcelona, Barcelona, Spain

Site Status

Countries

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Spain

References

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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.

Reference Type DERIVED

PMID: 32071136 (View on PubMed)

Other Identifiers

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Hyperosmolar_NCFB

Identifier Type: -

Identifier Source: org_study_id