PFF Clinical Trial Finder

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

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

Accepts Healthy Volunteers
No

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.

Study Type
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 ≥ 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 ≥ 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

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.

Trial ID:
NCT02712983

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
Phase 2

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Lead Sponsor
Novartis Pharmaceuticals

The person who is responsible for the scientific and technical direction of the entire clinical study.

Principal Investigator
Novartis Pharma
Principal Investigator Affiliation Novartis Pharmaceuticals

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Agency Class
Industry
Overall Status Recruiting
Countries Belgium, France, Germany, Italy, Netherlands, Spain, United Kingdom

The disease, disorder, syndrome, illness, or injury that is being studied.

Conditions
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.

International Sites

Novartis Investigative Site, Southampton, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Southampton, , SO16 6YD

Site Contact

+41613241111

Novartis Investigative Site, Newcastle upon Tyne, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Newcastle upon Tyne, , NE7 7DN

Site Contact

+41613241111

Novartis Investigative Site, London, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

London, , SW17 0QT

Site Contact

+41613241111

Novartis Investigative Site, London, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

London, , SW 6NP

Site Contact

+41613241111

Novartis Investigative Site, London, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

London, , EC14 7BE

Site Contact

+41613241111

Novartis Investigative Site, Leeds, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Leeds, , LS9 7TF

Site Contact

+41613241111

Novartis Investigative Site, Lancaster, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Lancaster, , LA1 4RP

Site Contact

+41613241111

Novartis Investigative Site, Glasgow, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Glasgow, , G51 4TF

Site Contact

+41613241111

Novartis Investigative Site, Edinburgh, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Edinburgh, , ED16 4SA

Site Contact

+41613241111

Novartis Investigative Site, Birmingham, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Birmingham, , B15 2TH

Site Contact

+41613241111

Novartis Investigative Site, Belfast, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Belfast, , BT9 7AB

Site Contact

+41613241111

Novartis Investigative Site, Dundee, Perthshire, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Dundee, Perthshire, DD1 9SY

Site Contact

+41613241111

Novartis Investigative Site, Penarth, Cardiff, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Penarth, Cardiff, CF64 2XX

Site Contact

+41613241111

Novartis Investigative Site, Huntingdon, Cambridgeshire, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Huntingdon, Cambridgeshire, PE29 6NT

Site Contact

+41613241111

Novartis Investigative Site, Cambridge, Cambridgeshire, United Kingdom

Status

Recruiting

Address

Novartis Investigative Site

Cambridge, Cambridgeshire, CB23 3RE

Site Contact

+41613241111

Novartis Investigative Site, Valladolid, Spain

Status

Recruiting

Address

Novartis Investigative Site

Valladolid, , 47003

Site Contact

+41613241111

Novartis Investigative Site, Valencia, Spain

Status

Recruiting

Address

Novartis Investigative Site

Valencia, , 46009

Site Contact

+41613241111

Novartis Investigative Site, Barcelona, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, , 08006

Site Contact

+41613241111

Novartis Investigative Site, Barcelona, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, , 08003

Site Contact

+41613241111

Novartis Investigative Site, Barakaldo, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barakaldo, , 48903

Site Contact

+41613241111

Novartis Investigative Site, Valencia, Comunitat Valencia, Spain

Status

Recruiting

Address

Novartis Investigative Site

Valencia, Comunitat Valencia, 46014

Site Contact

+41613241111

Novartis Investigative Site, Barcelona, Catalunya, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, Catalunya, 08041

Site Contact

+41613241111

Novartis Investigative Site, Barcelona, Catalunya, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, Catalunya, 08036

Site Contact

+41613241111

Novartis Investigative Site, Barcelona, Cataluna, Spain

Status

Recruiting

Address

Novartis Investigative Site

Barcelona, Cataluna, 08035

Site Contact

+41613241111

Novartis Investigative Site, Rotterdam, Netherlands

Status

Recruiting

Address

Novartis Investigative Site

Rotterdam, , 3000 CA

Site Contact

+41613241111

Novartis Investigative Site, Scafati, Italy

Status

Recruiting

Address

Novartis Investigative Site

Scafati, , 84018

Site Contact

+41613241111

Novartis Investigative Site, Pavia, Italy

Status

Recruiting

Address

Novartis Investigative Site

Pavia, , 27100

Site Contact

+41613241111

Novartis Investigative Site, Milan, Italy

Status

Recruiting

Address

Novartis Investigative Site

Milan, , 20112

Site Contact

+41613241111

Novartis Investigative Site, Pordenone, PN, Italy

Status

Recruiting

Address

Novartis Investigative Site

Pordenone, PN, 33170

Site Contact

+41613241111

Novartis Investigative Site, Pisa, PI, Italy

Status

Recruiting

Address

Novartis Investigative Site

Pisa, PI, 56124

Site Contact

+41613241111

Novartis Investigative Site, Monza, MB, Italy

Status

Recruiting

Address

Novartis Investigative Site

Monza, MB, 20900

Site Contact

+41613241111

Novartis Investigative Site, Genova, GE, Italy

Status

Recruiting

Address

Novartis Investigative Site

Genova, GE, 16132

Site Contact

+41613241111

Novartis Investigative Site, Neu-Isenburg, Germany

Status

Recruiting

Address

Novartis Investigative Site

Neu-Isenburg, , 63263

Site Contact

+41613241111

Novartis Investigative Site, Leipzig, Germany

Status

Recruiting

Address

Novartis Investigative Site

Leipzig, , 04357

Site Contact

+41613241111

Novartis Investigative Site, Hannover, Germany

Status

Recruiting

Address

Novartis Investigative Site

Hannover, , 30625

Site Contact

+41613241111

Novartis Investigative Site, Frankfurt, Germany

Status

Recruiting

Address

Novartis Investigative Site

Frankfurt, , 60596

Site Contact

+41613241111

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 14059

Site Contact

+41613241111

Novartis Investigative Site, Berlin, Germany

Status

Recruiting

Address

Novartis Investigative Site

Berlin, , 12200

Site Contact

+41613241111

Novartis Investigative Site, Essen, North Rhine-Westphalia, Germany

Status

Recruiting

Address

Novartis Investigative Site

Essen, North Rhine-Westphalia, 45239

Site Contact

+41613241111

Novartis Investigative Site, Toulouse, France

Status

Recruiting

Address

Novartis Investigative Site

Toulouse, , 31059

Site Contact

+41613241111

Novartis Investigative Site, Paris, France

Status

Recruiting

Address

Novartis Investigative Site

Paris, , 75014

Site Contact

+41613241111

Novartis Investigative Site, Grenoble, France

Status

Recruiting

Address

Novartis Investigative Site

Grenoble, , 38043

Site Contact

+41613241111

Novartis Investigative Site, Montpellier cedex 5, Herault, France

Status

Recruiting

Address

Novartis Investigative Site

Montpellier cedex 5, Herault, 34059

Site Contact

+41613241111

Novartis Investigative Site, Nice, Cedex1, France

Status

Recruiting

Address

Novartis Investigative Site

Nice, Cedex1, 06001

Site Contact

+41613241111

Novartis Investigative Site, Bayonne, Bayonne Cedex, France

Status

Recruiting

Address

Novartis Investigative Site

Bayonne, Bayonne Cedex, 64109

Site Contact

+41613241111

Novartis Investigative Site, Leuven, Belgium

Status

Recruiting

Address

Novartis Investigative Site

Leuven, , 3000

Site Contact

+41613241111

Novartis Investigative Site, Bruxelles, Belgium

Status

Recruiting

Address

Novartis Investigative Site

Bruxelles, , 1070

Site Contact

+41613241111

Terms of Service

The PFF does not promote or represent that any investigational new drugs mentioned are safe or effective. The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation. The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. For a full description of terms please refer to our Terms, Conditions & Privacy.

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