Sustained Effects of Hypertonic Saline on Mucociliary Clearance in Subjects With Chronic Bronchitis

Learn more about:
Related Clinical Trial
COVID-19 Phobia in Patients With Bronchiectasis During Covid-19 Pandemic Identification of Microbiome of Bronchiectasis in Chinese Population. Lung Damage Caused by SARS-CoV-2 Pneumonia (COVID-19) Lidocaine Administration During Flexible Bronchoscopy and Endobronchial Ultrasound COPD Patient-Powered Research Network Can we Reduce Hospital Attendance Without Compromising Care by the Use of Telephone Consultation Sustained Effects of Hypertonic Saline on Mucociliary Clearance in Subjects With Chronic Bronchitis Seoul National University Airway Registry VX-770 for the Treatment of Chronic Bronchitis Etiologies, Investigations and Outcomes of Patients Presenting With Hemoptysis Adherence to Airway Clearance. Novel Approaches to Improving Adherence Inhaled Molgramostim (rhGM-CSF) in Healthy Adult Subjects Prevalence of Respiratory Impairment During IBD The SENSOR Study: A Mixed-methods Study of SElf-management Checks to Predict exacerbatioNs of Pseudomonas Aeruginosa in Patients With Long-term reSpiratORy Conditions The Effect of Proprioceptive Neuromuscular Facilitation (PNF) Technique for Children With Chronic Pulmonary Diseases. Effect of HFCWO Vests on Spirometry Measurements Effect of High Frequency Chest Wall Oscillation Vests on Spirometry Measurements Epidemiology and Diagnosis of Haemoptysis: a Multicenter Study Evaluating the Effects of Traditional Chinese Medicine by N-of-1 Trials A Study to Evaluate the Safety, Tolerability, Pharmacokinetics (PK), Pharmacodynamics (PD) and Food Effect of Single or Repeat Doses of GSK2793660 in Healthy Subjects Biological Determinants of Sputum Rheology in Chronic Airway Diseases A Pilot Study to Investigate Administration of Mannitol Via a Novel Dry Powder Inhaler Device Efficacy and Safety Study of a Percussion Device to Mobilise Sputum From Respiratory Passage ATP and Capsaicin Cough Provocation Test in Chronic Cough and Bronchiectasis Summative Usability Study of Ciprofloxacin Dry Powder for Inhalation Using Placebo Lung Clearance Index (LCI) in Pediatric Patients With Obstructive Lung Disease The Prevalence of Gastro-oesophageal Reflux in Chronic Lung Disease High Dose Inhaled Mannitol Study Macrolide Mediates Pulmonary Infection of Pseudomonas Aeruginosa Respiratory Muscle Strength in Bronchiectasis: Repeatability and Reliability Longitudinal Study of Helium-3 and Xenon-129 Magnetic Resonance Imaging The Effect of Long Term Therapy With High Flow Humidification Compared to Usual Care in Patients With Bronchiectasis (BX) Evaluation Of The Lung Microbiome In NTM Bronchiectasis Inhalation Flow Rate-study Evaluation of the Effect of AZD5069 in Patients With Bronchiectasis Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis Procalcitonin-Guided Antibiotic Therapy in Bronchiectasis Inspiratory Flow and Volumes in Bronchiectatics Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD Evaluation of Periodontal Treatment in Patients With Bronchiectasis Long Term Nebulised Gentamicin in Patients With Bronchiectasis Comparison of PR Efficiency in Home-based With Hospital-based PR in Bronchiectasis Safety, Efficacy and PK/PD of POL7080 in Patients With Exacerbation of Non-cystic Fibrosis Bronchiectasis. Study of the Effect of FLUTTER® VRP1 (PEP and Oscillating High Frequency). Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis A Trial of Atorvastatin as an Anti-Inflammatory Agent in Non-Cystic Fibrosis Bronchiectasis Effects of Chest Physiotherapy (CPT) on Lung Clearance Index (LCI) in Non Cystic Fibrosis (CF) Bronchiectasis Randomised Open Label Trial of Hypertonic Saline and Carbocisteine in Bronchiectasis (CLEAR) Tobramycin in Bronchiectasis Colonized With Pseudmonas Aeruginosa Pulmonary Rehabilitation in Non Cystic Fibrosis Bronchiectasis Therapy of Bronchoalveolar Lavage and Local Amikacin Injection in Patients With Acute Exacerbation of Bronchiectasis Physiological Effects of Expiration With the Glottis Open in Lateral Posture (ELTGOL) and Flutter Valve in Patients With Bronchiectasis Comparison of the Efficacy of Comprehensive Respiratory Physiotherapy in Children With Cystic Fibrosis and Non-Cystic Fibrosis Bronchiectasis Safety and Efficacy of Oral BAY85-8501 in Patients With Non-CF (Cystic Fibrosis) Bronchiectasis Safety and Tolerability Study of 2 Dose Level of Arikayce™ in Patients With Bronchiectasis and Chronic Infection Due to Pseudomonas Aeruginosa. Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis The Long Term Effect of Inhaled Hypertonic Saline (6%) in Patients With Non Cystic Fibrosis Bronchiectasis Sputum Clearance Effects of Hypertonic Saline in Non-cystic Fibrosis Bronchiectasis Safety and Efficacy of Bronchitol in Bronchiectasis Predictors of Physical Activity Performance and Dynamic Hyperinflation in Patients With Bronchiectasis Oscillating PEP vs Autogenic Drainage in People With Bronchiectasis Feasibility of Interval Exercise in Bronchiectasis Prognosis of Bronchiectasis in Children–A Multicenter Prospective Cohort Study Exercise Training in Patients With Non-cystic Fibrosis (CF) Bronchiectasis Effects of Inspiratory Muscle Training in Patients With Bronchiectasis Acute Effects of a Flutter Device and Chest Wall Compression on Respiratory System Impedance in Bronchiectasis Patients Vitamin D as an Adjunctive Treatment in Patients With Non-Cystic Fibrosis Bronchiectasis Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis Cardiovascular Comorbidities and Bronchiectasis The Effect of Different Virtual Reality-Based Exercise Trainings on Pulmonary Function, Respiratory and Peripheral Muscle Strength, Functional Capacity and Balance in Children With Bronchiectasis Functional Respiratory Imaging in Bronchiectasis Safety and Potential Efficacy of Human Mesenchymal Stem Cells in Non‐Cystic Fibrosis Bronchiectasis Long-term Prognosis of Children With Bronchiectasis Treated With Low-dose Erythromycin Intervention Formoterol-beclomethasone in Patients With Bronchiectasis: a Randomized Controlled Trial Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis Safety and Effectiveness of AZLI (an Inhaled Antibiotic) in Adults With Non-Cystic Fibrosis Bronchiectasis Feasibility Study of the AffloVest in Bronchiectasis Atorvastatin in Bronchiectasis in Patients With Pseudomonas Aeruginosa The Effect of Theophylline in the Treatment of Bronchiectasis Bronchiectasis and Long Term Azithromycin Treatment Clinimetric Properties of Outcome Measures in Bronchiectasis in the UK Ciprofloxacin Dry Powder for Inhalation (DPI) in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) Pain Mechanisms in Patients With Bronchiectasis Efficacy of Roflumilast on Exacerbations in Patients With Non-cystic Fibrosis Bronchiectasis A Study to Access Safety and Efficacy of Nebulized Tobramycin in Patients With Bronchiectasis Bronchoalveolar Lavage for Bronchiectasis Patients With Exacerbation Efficacy of Azithromycin in Treatment of Bronchiectasis Airway Clearance in Bronchiectasis: is Non-Invasive Ventilation a Useful Adjunct in Moderate to Severe Disease? Effects of Azithromycin on Airway Oxidative Stress Markers in Patients With Bronchiectasis Efficacy of Budesonide-Formoterol in Bronchiectasis Exhaled Breath Condensate Assessment in Stable Non-Cystic Fibrotic Bronchiectasis Ciprofloxacin Dry Powder for Inhalation in Non-cystic Fibrosis Bronchiectasis (Non-CF BE) Long-term Airway Clearance Therapy in Non-cystic Fibrosis Bronchiectasis Bacterial Load Guided Therapy for Severe Bronchiectasis Exacerbations Study of Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of QBW251 in Subjects With Bronchiectasis Mucus Solids Concentration in Patients With Bronchiectasis Target Validation and Discovery in Idiopathic Bronchiectasis Exercise Capacity in Bronchiectasis Resection Physical Activity in Bronchiectasis The Role of Theophylline Plus Low-dose Formoterol-budesonide in Treatment of Bronchiectasis Effect of AIRVO Heated Humidification in Bronchiectasis A Safety Trial of DAS181 (Fludase®) in Adult Subjects With Well-Controlled Asthma or Bronchiectasis A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis Salmeterol-Fluticasone Combined Inhaled Therapy for Non-cystic Fibrosis Bronchiectasis Lung Dispersing, Turbid Descending and Gut Clearing Decoction for Bronchiectasis Is Regular Chest Physiotherapy an Effective Treatment in Severe, Non Cystic Fibrosis Bronchiectasis? Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis Autologous Transplantation of Bronchial Basal Cells for Treatment of Bronchiectasis Efficacy and Safety of Hydrogen Inhalation on Bronchiectasis: A Randomized, Multi-center, Double-blind Study Effect of Roflumilast on Quality of Life, Lung Function and Mucus Properties in Patients With Bronchiectasis Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis Reaction Time and Postural Control in Individuals With Cystic Fibrosis and Bronchiectasis Impact of Chronic Air Pollution on Non-cystic Fibrosis Bronchiectasis Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects Assessment of Early Outcomes of Roflumilast in Patients With Non Cystic Fibrosis Bronchiectasis Hypertonic Saline (6%) Versus Isotonic Saline (0.9%) in Bronchiectasis Evaluation of the Quality of Life Questionnaire-Bronchiectasis (QOL-B) in Patients With Bronchiectasis The Effect of Bronchiectasis on the Exacerbation and Mortality in COPD Inhaled A1AT in Adult Stable Bronchiectasis Prevention of Bronchiectasis in Infants With Cystic Fibrosis Pulmonary Rehabilitation in Non-Cystic Fibrosis Bronchiectasis Metabolomic Analysis of Exhaled Breath Condensates in Patients With COPD and Bronchiectasis Physical Capacity in Patients With Bronchiectasis Before and After Rehabilitation Program In-exsufflator Cough Assist Device in Patients With Symptomatic Bronchiectasis Bronchiectasis Effect in COPD Patients Prevalence and Characteristics of Patients With Bronchiectasis Comorbid Nontuberculous Mycobacteria Aetiology of Children With Bronchiectasis in China Macrolides in COPD- Bronchiectasis Overlap Value of Inhaled Treatment With Aztreonam Lysine in Bronchiectasis Pharmacokinetic Evaluation and Tolerability of Dry Powder Tobramycin by a Novel Device in Patients With Non Cystic Fibrosis Bronchiectasis Comparison of Sit-to-stand Test With Six-minute Walk Test in Bronchiectasis and Healthy Children Characterization of Airway Mucus in Bronchiectasis Patients and Healthy Controls The PROspective German NOn-CF bronchiectaSIS Patient Registry The BRIDGE Study – Bronchiectasis Research Involving Databases, Genomics and Endotyping Role of Innate Immunity in Non-Cystic Fibrosis Bronchiectasis Exercise Capacity in Patients With Cystic Fibrosis vs. Non-cystic Fibrosis Bronchiectasis Evaluation of Medical and Nursing Management for Bronchiectasis A Pilot Study to Evaluate the Use of the Vest® System for Treatment of Bronchiectasis Patients in the Home Setting The Establishment of China Bronchiectasis Registry and Research Collaboration Short-and Long-term Effects of a Home-based Rehabilitation Program in Patients With Bronchiectasis The Role of Viral Infection in Acute Exacerbations of Non-cystic Fibrosis Bronchiectasis in Adults Bronchiectasis: Evaluation of an Educational Intervention Prevalence of Bronchiectasis in COPD Patients ELTGOL and Bronchiectasis. Respiratory Therapy Bacteriology and Inflammation in Bronchiectasis Different Phenotypes of Bronchiectasis Effects of Traditional Chinese Medicine on Bronchiectasis Patients The Prevalence and Impact of Depression and Anxiety Symptoms in Patients With Non-CF Bronchiectasis

Brief Title

Sustained Effects of Hypertonic Saline on Mucociliary Clearance in Subjects With Chronic Bronchitis

Official Title

Novel Therapies for Muco-Obstructive Lung Diseases: Sustained Effects of Hypertonic Saline on Mucociliary Clearance and Clinical Tolerability in Subjects With Chronic Bronchitis

Brief Summary

      The purpose of this research study is to examine the effects of two weeks of daily dosing of
      inhaled salt water mist (hypertonic saline - HS) on actual measurements of mucociliary and
      cough clearance in patients with the chronic bronchitis type of Chronic Obstructive Pulmonary
      Disease (COPD.

      Defective mucociliary clearance (MCC) is central to the development and/or worsening of
      several kinds of lung diseases, including COPD/chronic bronchitis (CB), cystic fibrosis (CF),
      and bronchiectasis. In each case, defective MCC leads to the development of lung infections
      and damage to the airways from ongoing inflammation caused by a person's inability to clear
      mucus from the lungs.

      The investigators' previous studies have shown that the administration of inhaled HS
      (hypertonic saline) not only acutely accelerates MCC in CF, but also that repetitive use
      "resets" the baseline rate of MCC within 2 weeks. It is likely that the sustained effect of
      HS on MCC was responsible for the ~60% reduction in the frequency of pulmonary disease
      exacerbations, reduced antibiotic use and improved lung function in a long-term study of HS
      in CF volunteers. As a result, HS has now become a standard therapy for CF lung disease and
      its success raises optimism that similar benefits might occur in patients with CB.

      In this study the investigators will use mildly radioactive particles, technetium bound to
      sulfur colloid, to measure and compare the sustained effects on mucus clearance of two weeks
      of daily dosing of 7% hypertonic saline versus a low salt control treatment for subjects with
      CB. We will also be collecting sputum and breath condensation to analyze for protein and
      inflammatory changes that might occur with exacerbations.

      Our long term goals are to improve our understanding of MCC in health and disease and to
      develop better therapies that support and/or restore MCC in patients with these diseases to
      reduce lung infections.
    



Study Type

Interventional


Primary Outcome

Measure and compare the sustained effects on mucus clearance of two weeks of daily dosing of hypertonic saline versus a low salt control treatment for subjects with CB.

Secondary Outcome

 We will also be collecting sputum and breath condensation to analyze for protein and inflammatory changes that might occur with exacerbations.

Condition

Chronic Obstructive Pulmonary Disease

Intervention

Inhaled 7% HS (NaCl) home treatment

Study Arms / Comparison Groups

 AB: 7% HS home tx, then 0.12% NaCl
Description:  Inhaled Inhaled 7% HS (hypertonic saline) home treatment' , then 0.12% sodium chloride solution home treatment.
The intervention consists of the subject receiving both concentrations of inhaled sodium chloride solution, each during a different home treatment periods. Subjects randomized to order AB will receive inhaled 7% NaCl (sodium chloride solution) mist during the first home treatment period, then 0.12% NaCL during the second home treatment period.

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

25

Start Date

February 2013

Completion Date

May 2016

Primary Completion Date

May 2016

Eligibility Criteria

        Inclusion Criteria:

        Volunteers who meet all of the following criteria will be eligible for study participation:

          1. Age 40-80 years, inclusive

          2. Non-pregnant subjects must be either not sexually active, post-menopausal, surgically
             sterilized, or agree to use an appropriate "double barrier" method (such as diaphragm
             and condom), or must currently be using a prescribed transdermal, injection, implant,
             or oral contraceptive during study participation.

          3. Forced expiratory volume in 1 second (FEV1) of 35-80% of predicted, inclusive, and
             FEV1/forced vital capacity (FVC) < 70%

          4. Produces mucus at least 2 days per week, on average

          5. History of smoking (≥ 10 pack years) -

        Exclusion Criteria:

        Volunteers will be excluded from the study if they meet any of the following criteria:

          1. Uses oxygen continuously during daytime hours (nighttime use OK)

          2. Requires > 10mg per day of prednisone (or equivalent corticosteroid dose) chronically

          3. Concomitant presence of congestive heart failure, active coronary syndromes, or other
             disease that in the opinion of the investigator would increase the risk resulting from
             participation

          4. Recent change in respiratory medications, including acute antibiotic or systemic
             corticosteroid interventions within the last 4 weeks

          5. History of intolerance or hypersensitivity to hypertonic saline or short acting
             inhaled beta agonist

          6. Significant broncho reactivity by examination or pulmonary function testing (PFT),
             that in the opinion of the investigator would increase the risk of HS use

          7. Radiation exposure within the 12 months prior to study participation that would cause
             them to exceed Federal Regulations by participating in this study

          8. Subjects with a positive pregnancy test

          9. Subjects who, in the opinion of the Principal Investigator, should not participate in
             the study

        Subjects may be temporarily excluded from screening should they experience a respiratory
        tract infection that requires treatment with antibiotics and/or steroids. They may become
        eligible for screening four weeks after completing their treatment providing their symptoms
        have resolved.

        -
      

Gender

All

Ages

40 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Ashley G Henderson, MD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01792271

Organization ID

12-2602

Secondary IDs

1P01HL108808-01A1

Responsible Party

Sponsor

Study Sponsor

University of North Carolina, Chapel Hill

Collaborators

 National Heart, Lung, and Blood Institute (NHLBI)

Study Sponsor

Ashley G Henderson, MD, Principal Investigator, University of North Carolina, Chapel Hill


Verification Date

June 2017