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Dose-finding Study to Assess the Efficacy, Safety and Tolerability of Tobramycin Inhalation Powder in Patients With Non-Cystic Fibrosis Bronchiectasis and Pulmonary P. Aeruginosa Infection
Study Purpose
The purpose of this study is to support the selection of a safe and tolerable tobramycin
inhalation powder (TIP) dose, and regimen that exhibits effective bacterial reduction of P.
aeruginosa in non-cystic fibrosis bronchiectasis (BE) patients with P. aeruginosa
colonization.
Recruitment Criteria
Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
No
Study Type
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
Interventional
Eligible Ages
18 Years and Over
Gender
All
More Inclusion & Exclusion Criteria
Inclusion Criteria:
- Written informed consent must be obtained before any assessment is performed.
- Male and female patients of ā„ 18 years of age at screening (Visit 1).
- Proven diagnosis of non-CF BE as documented by computed tomography or high-resolution
computed tomography
- At least 2 or more exacerbations treated with oral antibiotics OR 1 or more
exacerbation requiring intravenous antibiotic treatment within 12 months prior to
screening.
- FEV1 ā„ 30% predicted at screening (Visit 1).
- P.
aeruginosa, must be documented in a respiratory sample at least 1 time within 12
months and also present in the expectorated sputum culture at Visit 1.
Exclusion Criteria:
- Patients with a history of cystic fibrosis.
- Patients with a primary diagnosis of bronchial asthma.
- Patients with a primary diagnosis of COPD associated with at least a 20 pack year
smoking history.
- Any significant medical condition that is either recently diagnosed or was not stable
during the last 3 months, other than pulmonary exacerbations, and that in the opinion
of the investigator makes participation in the trial against the patients' best
interests.
- Clinically significant (in the opinion of the investigator) hearing loss that
interferes with patients' daily activities (such as normal conversations) or chronic
tinnitus.
Patients with a past history of clinically significant hearing loss in the
opinion of the investigator may be eligible only if their hearing threshold at
screening audiometry is 25dB or lower at frequencies 0.5-4 kHz. The use of a hearing
device is reflective of a clinically significant hearing loss; hence patients using
hearing aids at screening are not eligible.
- Patients with active pulmonary tuberculosis.
- Patients currently receiving treatment for nontuberculous mycobacterial (NTM)
pulmonary disease.
- Patients who are regularly receiving inhaled anti-pseudomonal antibiotic (during the
study inhaled anti-pseudomonal antibiotics are not allowed other than the study drug).
Trial Details
Trial ID:
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Phase 2
Lead Sponsor
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
Novartis Pharmaceuticals
Principal Investigator
The person who is responsible for the scientific and technical direction of the entire clinical study.
Novartis Pharma
Principal Investigator Affiliation
Novartis Pharmaceuticals
Agency Class
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
Industry
Overall Status
Recruiting
Countries
Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom
Conditions
The disease, disorder, syndrome, illness, or injury that is being studied.
Non-cystic Fibrosis Bronchiectasis
Additional Details
This is a blinded, randomized, dose- and regimen finding trial where active TIP doses or
placebo is given in addition to the local standard care.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.