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
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.
Study Type
Interventional
Primary Outcome
Wet sputum production
Secondary Outcome
Wet sputum production
Condition
Bronchiectasis
Intervention
Hypertonic saline solution
Study Arms / Comparison Groups
Hypertonic saline solution
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.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
24
Start Date
March 2015
Completion Date
January 2016
Primary Completion Date
December 2015
Eligibility Criteria
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)
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Eva Polverino, Dr., ,
Location Countries
Spain
Location Countries
Spain
Administrative Informations
NCT ID
NCT02392663
Organization ID
Hyperosmolar_NCFB
Responsible Party
Principal Investigator
Study Sponsor
Hospital Clinic of Barcelona
Study Sponsor
Eva Polverino, Dr., Principal Investigator, Hospital Clinic
Verification Date
November 2016