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

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ClinicalTrials.gov Identifier: NCT02392663
Recruitment Status : Completed
First Posted : March 19, 2015
Last Update Posted : November 15, 2016
Sponsor:
Information provided by (Responsible Party):
Eva Polverino, Hospital Clinic of Barcelona

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%).

Condition or disease Intervention/treatment Phase
Bronchiectasis Other: Hypertonic saline solution Other: Hyaneb solution Other: Isotonic saline solution Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis: a Randomized, Double-blind, Crossover Trial
Study Start Date : March 2015
Actual Primary Completion Date : December 2015
Actual Study Completion Date : January 2016

Arm Intervention/treatment
Active Comparator: 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.

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.

Active Comparator: 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.

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.

Placebo Comparator: 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.

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.




Primary Outcome Measures :
  1. Wet sputum production [ Time Frame: 1h wet sputum production (g) ]
    Sputum collected during nebulization period and physiotherapy session


Secondary Outcome Measures :
  1. Wet sputum production [ Time Frame: 24h wet sputum production (g) ]
    Spontaneous sputum expectorated during the following 24h after intervention

  2. Impact on cough severity (Leicester Cough Questionnaire) [ Time Frame: One week ]
    Self-administered questionnaire (Leicester Cough Questionnaire)

  3. Lung function (Forced spirometry) [ Time Frame: One week ]
    Forced spirometry: forced expiratory volume in 1 second, Forced vital capacity, Forced expiratory flow 25-75

  4. Safety and tolerability (Adverse events) [ Time Frame: 20 minutes ]
    Adverse events registration during the nebulization process (heart rate, saturation and dyspnoea)


Other Outcome Measures:
  1. Patients´preference (Likert test) [ Time Frame: 5 weeks ]
    Self-administered "Likert test" at the end of the trial



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02392663


Locations
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Spain
Hospital Clinic
Barcelona, Spain, 08036
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
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Principal Investigator: Eva Polverino, Dr. Hospital Clinic

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Responsible Party: Eva Polverino, Post doctoral investigator, Hospital Clinic of Barcelona
ClinicalTrials.gov Identifier: NCT02392663     History of Changes
Other Study ID Numbers: Hyperosmolar_NCFB
First Posted: March 19, 2015    Key Record Dates
Last Update Posted: November 15, 2016
Last Verified: November 2016

Keywords provided by Eva Polverino, Hospital Clinic of Barcelona:
Sputum clearance
Cough severity
Hypertonic saline
Acid hyaluronic
Tolerability

Additional relevant MeSH terms:
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Bronchiectasis
Bronchial Diseases
Respiratory Tract Diseases
Pharmaceutical Solutions