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

Bronchiectasis Clinical Trial

Official title:

Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis: a Randomized, Double-blind, Crossover Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02392663
• Other study ID #: Hyperosmolar_NCFB
• Status: Completed
• Phase: N/A
• First received: March 13, 2015
• Last updated: November 11, 2016
• Start date: March 2015
• Est. completion date: January 2016

Study information

• Verified date: November 2016
• Source: Hospital Clinic of Barcelona
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ethics Committee
• Study type: Interventional

Clinical 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). 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%).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 24
• Est. completion date: January 2016
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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)

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bronchiectasis

Intervention

Other:
• 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.
• 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.
• 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.

Locations

Country	Name	City	State
Spain	Hospital Clinic	Barcelona

Sponsors (1)

Lead Sponsor	Collaborator
Hospital Clinic of Barcelona

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Patients´preference (Likert test)	Self-administered "Likert test" at the end of the trial	5 weeks	No
Primary	Wet sputum production	Sputum collected during nebulization period and physiotherapy session	1h wet sputum production (g)	No
Secondary	Wet sputum production	Spontaneous sputum expectorated during the following 24h after intervention	24h wet sputum production (g)	No
Secondary	Impact on cough severity (Leicester Cough Questionnaire)	Self-administered questionnaire (Leicester Cough Questionnaire)	One week	No
Secondary	Lung function (Forced spirometry)	Forced spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75	One week	No
Secondary	Safety and tolerability (Adverse events)	Adverse events registration during the nebulization process (heart rate, saturation and dyspnoea)	20 minutes	No