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
NCT ID: NCT02712983
Last Updated: 2020-08-25
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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COMPLETED
PHASE2
107 participants
INTERVENTIONAL
2017-02-08
2019-03-20
Brief Summary
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Detailed Description
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Novartis decided to close the recruitment of new subjects into this study earlier than scheduled. Subjects who had a signed informed consent form and entered screening by 10-Sep-2018 still participated in the study. The latest possible randomization was on 08-Oct-2018. All subjects enrolled in the study (107 enrolled subjects out of 180 planned) continued as planned through to their last scheduled visit. The early recruitment halt of the study was not due to safety or lack of efficacy.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Cohort A (3 capsules o.d.): TIP
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP)
TIP
TIP dose regimen
Cohort A (3 capsules o.d.): TIP/PBO
Cohort A (3 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
TIP and placebo
TIP and inhaled placebo dose regimen
Cohort A (3 capsules o.d.): PBO
Cohort A (3 capsules o.d.): Inhaled placebo (PBO)
Placebo
Inhaled placebo dose regimen
Cohort B (5 capsules o.d.): TIP
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP)
TIP
TIP dose regimen
Cohort B (5 capsules o.d.): TIP/PBO
Cohort B (5 capsules o.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
TIP and placebo
TIP and inhaled placebo dose regimen
Cohort B (5 capsules o.d.): PBO
Cohort B (5 capsules o.d.): inhaled placebo (PBO)
Placebo
Inhaled placebo dose regimen
Cohort C (4 capsules b.i.d.): TIP
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP)
TIP
TIP dose regimen
Cohort C (4 capsules b.i.d.): TIP/PBO
Cohort C (4 capsules b.i.d.): Tobramycin inhalation powder (TIP) and inhaled placebo (PBO) cyclical
TIP and placebo
TIP and inhaled placebo dose regimen
Cohort C (4 capsules b.i.d.): PBO
Cohort C (4 capsules b.i.d.): inhaled placebo (PBO)
Placebo
Inhaled placebo dose regimen
Interventions
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TIP
TIP dose regimen
TIP and placebo
TIP and inhaled placebo dose regimen
Placebo
Inhaled placebo dose regimen
Eligibility Criteria
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Inclusion Criteria
* 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 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).
18 Years
ALL
No
Sponsors
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Queen's University, Belfast
OTHER
University Hospital, Antwerp
OTHER
University of Milan
OTHER
Fundacion Clinic per a la Recerca Biomédica
OTHER
Erasmus Medical Center
OTHER
Papworth Hospital NHS Foundation Trust
OTHER_GOV
Royal Brompton & Harefield NHS Foundation Trust
OTHER
University of Dundee
OTHER
University of Edinburgh
OTHER
Novartis Pharmaceuticals
INDUSTRY
Responsible Party
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Principal Investigators
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Novartis Pharma
Role: STUDY_DIRECTOR
Novartis Pharmaceuticals
Locations
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Novartis Investigative Site
Brussels, , Belgium
Novartis Investigative Site
Leuven, , Belgium
Novartis Investigative Site
Nice, Cedex1, France
Novartis Investigative Site
Montpellier, Herault, France
Novartis Investigative Site
Grenoble, , France
Novartis Investigative Site
Toulouse, , France
Novartis Investigative Site
Essen, North Rhine-Westphalia, Germany
Novartis Investigative Site
Berlin, , Germany
Novartis Investigative Site
Frankfurt, , Germany
Novartis Investigative Site
Hanover, , Germany
Novartis Investigative Site
Leipzig, , Germany
Novartis Investigative Site
Monza, MB, Italy
Novartis Investigative Site
Pisa, PI, Italy
Novartis Investigative Site
Pordenone, PN, Italy
Novartis Investigative Site
Milan, , Italy
Novartis Investigative Site
Pavia, , Italy
Novartis Investigative Site
Scafati, , Italy
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Barcelona, Catalonia, Spain
Novartis Investigative Site
Valencia, Comunitat Valencia, Spain
Novartis Investigative Site
Baracaldo - Vizcaya, , Spain
Novartis Investigative Site
Barcelona, , Spain
Novartis Investigative Site
Valencia, , Spain
Novartis Investigative Site
Valladolid, , Spain
Novartis Investigative Site
Cambridge, Cambridgeshire, United Kingdom
Novartis Investigative Site
Dundee, Perthshire, United Kingdom
Novartis Investigative Site
Birmingham, , United Kingdom
Novartis Investigative Site
Edinburgh, , United Kingdom
Novartis Investigative Site
Lancaster, , United Kingdom
Novartis Investigative Site
Leeds, , United Kingdom
Novartis Investigative Site
London, , United Kingdom
Novartis Investigative Site
Newcastle upon Tyne, , United Kingdom
Novartis Investigative Site
Southampton, , United Kingdom
Countries
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References
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Loebinger MR, Polverino E, Chalmers JD, Tiddens HAWM, Goossens H, Tunney M, Ringshausen FC, Hill AT, Pathan R, Angyalosi G, Blasi F, Elborn SJ, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of TOBI Podhaler in Pseudomonas aeruginosa-infected bronchiectasis patients: iBEST study. Eur Respir J. 2021 Jan 5;57(1):2001451. doi: 10.1183/13993003.01451-2020. Print 2021 Jan.
Loebinger MR, Polverino E, Blasi F, Elborn SJ, Chalmers JD, Tiddens HA, Goossens H, Tunney M, Zhou W, Angyalosi G, Hill AT, Haworth CS; iBEST-1 Trial Team. Efficacy and safety of tobramycin inhalation powder in bronchiectasis patients with P. aeruginosa infection: Design of a dose-finding study (iBEST-1). Pulm Pharmacol Ther. 2019 Oct;58:101834. doi: 10.1016/j.pupt.2019.101834. Epub 2019 Aug 18.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2015-003040-39
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
CTBM100G2202
Identifier Type: -
Identifier Source: org_study_id
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