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Second Open Label Extension to Bridging Study CTBM100C2303

NCT ID: NCT01069705

Last Updated: 2021-06-02

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

49 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-12

Study Completion Date

2012-03-19

Brief Summary

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This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.

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Detailed Description

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Conditions

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Pulmonary Infections Pseudomonas Aeruginosa

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Tobramycin Inhalation Powder (TIPnew)

Participants received four capsules of 28 mg TIPnew (112 mg), inhaled twice a day (b.i.d.) in the morning and the evening given in a cycle of 28 days on treatment followed by 28 days off treatment for three consecutive cycles.

Group Type EXPERIMENTAL

Tobramycin inhalation powder

Intervention Type DRUG

Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.

Interventions

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Tobramycin inhalation powder

Tobramycin dry powder for inhalation in capsules administered by the T-326 inhaler.

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study CTBM100C2303E1 took place not more than 5 days before enrollment into this study.
* Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.
* Forced Expiratory Volume in one second (FEV1) at screening (at start of study CTBM100C2303) must be between 25% and 80% of normal predicted values.

Exclusion Criteria

* Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial CTMB100C2303E1 and the enrollment into this study.
* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
Minimum Eligible Age

6 Years

Maximum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Pleven, , Bulgaria

Site Status

Novartis Investigative Site

Plovdiv, , Bulgaria

Site Status

Novartis Investigative Site

Sofia, , Bulgaria

Site Status

Novartis Investigative Site

Varna, , Bulgaria

Site Status

Novartis Investigative Site

Tallinn, , Estonia

Site Status

Novartis Investigative Site

Tartu, , Estonia

Site Status

Novartis Investigative Site

Riga, , Latvia

Site Status

Novartis Investigative Site

Kaunas, , Lithuania

Site Status

Novartis Investigative Site

Vilnius, , Lithuania

Site Status

Novartis Investigative Site

Bucharest, , Romania

Site Status

Novartis Investigative Site

Timișoara, , Romania

Site Status

Novartis Investigative Site

Kazan', , Russia

Site Status

Novartis Investigative Site

Moscow, , Russia

Site Status

Novartis Investigative Site

Saint Petersburg, , Russia

Site Status

Novartis Investigative Site

Samara, , Russia

Site Status

Novartis Investigative Site

Yaroslavl, , Russia

Site Status

Novartis Investigative Site

Durban, , South Africa

Site Status

Countries

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Bulgaria Estonia Latvia Lithuania Romania Russia South Africa

References

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Konstan MW, Flume PA, Galeva I, Wan R, Debonnett LM, Maykut RJ, Angyalosi G. One-year safety and efficacy of tobramycin powder for inhalation in patients with cystic fibrosis. Pediatr Pulmonol. 2016 Apr;51(4):372-8. doi: 10.1002/ppul.23358. Epub 2015 Dec 27.

Reference Type RESULT
PMID: 26709158 (View on PubMed)

Other Identifiers

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CTBM100C2303E2

Identifier Type: -

Identifier Source: org_study_id

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