Inhaled Mannitol as a Mucoactive Therapy for Bronchiectasis

Status Completed

Clinical Trial Summary

No gold standard therapy exists for clearing mucus from the airways of patients with bronchiectasis. While rhDNase has a proven place in the treatment of CF, it failed to improve FEV1 in a short-term non-CF bronchiectasis study and has been shown to be detrimental after 6 months therapy in non CF bronchiectasis, moreover it has no proven effect on mucociliary clearance. Hypertonic saline has been shown to have a comparable mode of action to inhaled mannitol, but has yet to be examined as a long term treatment option in bronchiectasis.

The purpose of this study is to examine the efficacy and safety of 52 weeks treatment with inhaled mannitol in subjects with non-cystic fibrosis bronchiectasis. Previous studies with inhaled mannitol have demonstrated improvement in mucociliary clearance; mucus rehydration; improvement in quality of life and respiratory symptoms in patients with bronchiectasis and pulmonary function in cystic fibrosis. The results of this current study in combination with a recently completed 3 month study seek to confirm these early findings and to extend the evidence to support its use as a mucoactive therapy in subjects with bronchiectasis.

We hypothesize that mannitol will improve the overall health and hygiene of the lung through regular and effective clearing of the mucus load. As a consequence of the reduction in mucus load and inflammatory process, the frequency of bronchiectasis related pulmonary exacerbations and the need for exacerbation related antibiotic treatment should fall. Days in hospital and community health care costs are expected to change in line with improvements in respiratory health.

Finally, we plan to demonstrate that inhaled mannitol is safe and well tolerated over a 52 week period. We will test these hypotheses using 400 mg mannitol twice daily against control.

Clinical Trial Description

n/a

Study Design

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

Related Conditions & MeSH terms

Bronchiectasis

Clinical Trial Details

NCT number	NCT00669331
Study type	Interventional
Source	Pharmaxis
Contact
Status	Completed
Phase	Phase 3
Start date	November 2009
Completion date	January 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT05034900` - Does Addition of Oscillatory Positive Expiratory Pressure (OPEP) Device to a Chest Physiotherapy Program Provide Further Health Benefits in Children With Bronchiectasis?	N/A
Recruiting	`NCT04101448` - Prevalence of Bronchiectasis in COPD Patients
Withdrawn	`NCT03376204` - Pain Mechanisms in Patients With Bronchiectasis
Completed	`NCT02550821` - Comparison of Physical Activity Level Between Patients With Bronchiectasis and Healthy Subjects
Completed	`NCT02656992` - Effects of High Intensity Inspiratory Muscle Training on Exercise Capacity in Patients With Bronchiectasis	N/A
Completed	`NCT01615484` - Ex-vivo Perfusion and Ventilation of Lungs Recovered From Non-Heart-Beating Donors to Assess Transplant Suitability	N/A
Completed	`NCT02048397` - Pulmonary Rehabilitation Program (PRP) Versus PRP Plus Nutritional Supplementation in Patients With Bronchiectasis	N/A
Completed	`NCT02282202` - Evaluation of Oscillatory Positive Expiratory Pressure (oPEP) in Bronchiectasis and COPD	N/A
Recruiting	`NCT01761214` - Bacteriology and Inflammation in Bronchiectasis	N/A
Recruiting	`NCT02527486` - Seoul National University Airway Registry	N/A
Completed	`NCT01578681` - ELTGOL and Bronchiectasis. Respiratory Therapy	N/A
Completed	`NCT01854788` - 3 Airway Clearance Techniques in Non Cystic Fibrosis Bronchiectasis	N/A
Completed	`NCT00769119` - A Phase II , Placebo-controlled Study to Assess Efficacy of 28 Day Oral AZD9668 in Patients With Bronchiectasis	Phase 2
Terminated	`NCT00524095` - Bronchiectasis in Chronic Obstructive Pulmonary Disease (COPD) Patients: Role of Prophylaxis	Phase 2
Completed	`NCT01117493` - Expert Patient Self-management Programme Versus Usual Care in Bronchiectasis	N/A
Recruiting	`NCT00129350` - Assessment of Heart and Heart-Lung Transplant Patient Outcomes Following Pulmonary Rehabilitation	Phase 1
Completed	`NCT00656721` - Respiratory Mechanics Effects of Flutter Valve in Bronchiectasis Patients	N/A
Completed	`NCT04081740` - Biological Determinants of Sputum Rheology in Chronic Airway Diseases
Enrolling by invitation	`NCT02546297` - Comparisons of Inhaled LAMA or LAMA+LABA or ICS+LABA for COPD With Bronchiectasis	Phase 4
Completed	`NCT03628456` - Effect of HFCWO Vests on Spirometry Measurements	N/A

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.