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

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 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

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