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

NCT02392663 | Completed

• 1 other identifier: Hyperosmolar_NCFB
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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%).

Conditions

Bronchiectasis

Keywords

Sputum clearance; Cough severity; Hypertonic saline; Acid hyaluronic; Tolerability

Outcome Measures

Primary Outcomes (1)

• Wet sputum production

  Sputum collected during nebulization period and physiotherapy session

  1h wet sputum production (g)

Secondary Outcomes (4)

• Wet sputum production

  24h wet sputum production (g)

• Impact on cough severity (Leicester Cough Questionnaire)

  One week

• Lung function (Forced spirometry)

  One week

• Safety and tolerability (Adverse events)

  20 minutes

Other Outcomes (1)

• Patients´preference (Likert test)

  5 weeks

Study Arms (3)

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.

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.

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.

Other: Isotonic saline solution

Interventions

Hypertonic saline solution 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.

Hypertonic saline solution

Hyaneb solution 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

Isotonic saline solution 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Hospital Clinic of Barcelona: lead

Study Sites (1)

Hospital Clinic

Barcelona, Barcelona, 08036, Spain

Location

Related Publications (1)

• 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.

  PMID: 32071136 DERIVED

MeSH Terms

Conditions

Bronchiectasis

Interventions

Saline Solution, Hypertonic

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Hypertonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Eva Polverino, Dr.

  Hospital Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Post doctoral investigator

Study Record Dates

• First Submitted: March 13, 2015
• First Posted: March 19, 2015
• Study Start: March 1, 2015
• Primary Completion: December 1, 2015
• Study Completion: January 1, 2016
• Last Updated: November 15, 2016

Record last verified: 2016-11

Locations

ES (1)