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A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI® (CT03Ext)

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tobramycin
Sponsored by
Chiesi Farmaceutici S.p.A.
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cystic Fibrosis focused on measuring cystic fibrosis, P. aeruginosa, tobramycin

Eligibility Criteria

6 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Successful completion of Core Study
  • At least 6 years of age
  • Males and females

Sites / Locations

  • CHR Clemenceau
  • Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires
  • Hopital Necker
  • Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy
  • I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy
  • Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny
  • Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii
  • Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
  • Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
  • Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2
  • Klinika Pediatrii Instytut Matki I Dziecka
  • Dnipropetrovsk City Children Clinical Hospital # 2
  • Donetsk Regional Children Clinical Hospital
  • Kriviy Rig City Clinical Hospital # 8
  • Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine
  • Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine
  • Lviv Regional Children Specialized Clinical Hospital
  • Odesa Regional Children Clinical Hospital
  • Simferopol Central District Clinical Hospital
  • Zaporizhya Regional Clinical Children Hospital

Outcomes

Primary Outcome Measures

to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination.

Secondary Outcome Measures

to assess whether prolonged use of aerosolized tobramycin is required to sustain FEV1 increase (FEV1 expressed in liters and % predicted)
Categorical results of microbiological tests referred to P. aeruginosa (negativisation, persistence, superinfection, re-infection); susceptibility testing of isolated P. aeruginosa strains (MIC90 and MIC50)
Changes in body weight and BMI
to assess health related quality of life

Full Information

First Posted
April 13, 2010
Last Updated
July 30, 2020
Sponsor
Chiesi Farmaceutici S.p.A.
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1. Study Identification

Unique Protocol Identification Number
NCT01111383
Brief Title
A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
Acronym
CT03Ext
Official Title
A Single Arm 48-Week Follow-on Safety Study to the Core Study (A Multicentre, Multinational, Open-Label, Randomised, Parallel Group Clinical Trial of Tobrineb®/Actitob®/Bramitob® (Tobramycin Solution for Nebulisation, 300mg Twice Daily in 4mL Unit Dose Vials) Compared to TOBI® in the Treatment of Patients With Cystic Fibrosis and Chronic Infection With Pseudomonas Aeruginosa)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2011 (Actual)
Study Completion Date
May 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Chiesi Farmaceutici S.p.A.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
This is a 48-week extension study to CMA-0631-PR-0010 Core Study. Patients who have a positive culture for P. aeruginosa at visit 4 of the first 8-week core study period and/or if deemed appropriate by the Investigators will be able to be included in the 48-week follow-on period (Extension Study) to continue the treatment only with Bramitob® (tobramycin nebuliser solution, 300 mg twice daily in 4 mL unit dose vials).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
cystic fibrosis, P. aeruginosa, tobramycin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
209 (Actual)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
tobramycin
Other Intervention Name(s)
Tobrineb®/Actitob®/Bramitob®
Intervention Description
300mg/4ml solution, via a nebuliser, over a 48-week period in a twice-daily regimen, with 6 "on" cycles of 4 weeks duration during the 48-week period.
Primary Outcome Measure Information:
Title
to assess safety profile in terms of incidence of adverse events/adverse drug reactions, frequency of cystic fibrosis exacerbations, audiometric test, laboratory parameters (hematology and blood chemistry), vitals signs (hr and bp), physical examination.
Time Frame
up to 48 weeks
Secondary Outcome Measure Information:
Title
to assess whether prolonged use of aerosolized tobramycin is required to sustain FEV1 increase (FEV1 expressed in liters and % predicted)
Time Frame
up to 48 weeks
Title
Categorical results of microbiological tests referred to P. aeruginosa (negativisation, persistence, superinfection, re-infection); susceptibility testing of isolated P. aeruginosa strains (MIC90 and MIC50)
Time Frame
up to 48 weeks
Title
Changes in body weight and BMI
Time Frame
up to 48 weeks
Title
to assess health related quality of life
Time Frame
Initial visit, Week 20, Week 44

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Successful completion of Core Study At least 6 years of age Males and females
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henryk Mazurek, Doctor
Organizational Affiliation
Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHR Clemenceau
City
Caen
ZIP/Postal Code
14 033
Country
France
Facility Name
Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires
City
Montpellier
ZIP/Postal Code
34 295
Country
France
Facility Name
Hopital Necker
City
Paris
ZIP/Postal Code
75 015
Country
France
Facility Name
Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy
City
Gdansk
ZIP/Postal Code
80-308
Country
Poland
Facility Name
I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy
City
Kielce
ZIP/Postal Code
25-381
Country
Poland
Facility Name
Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii
City
Lublin
ZIP/Postal Code
20-093
Country
Poland
Facility Name
Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
City
Poznan
ZIP/Postal Code
60-572
Country
Poland
Facility Name
Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
City
Rabka Zdroj
ZIP/Postal Code
34-700
Country
Poland
Facility Name
Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2
City
Rzeszow
ZIP/Postal Code
35-301
Country
Poland
Facility Name
Klinika Pediatrii Instytut Matki I Dziecka
City
Warszawa
ZIP/Postal Code
01-211
Country
Poland
Facility Name
Dnipropetrovsk City Children Clinical Hospital # 2
City
Dnipropetrovsk
ZIP/Postal Code
49101
Country
Ukraine
Facility Name
Donetsk Regional Children Clinical Hospital
City
Donetsk
ZIP/Postal Code
83052
Country
Ukraine
Facility Name
Kriviy Rig City Clinical Hospital # 8
City
Kriviy Rig
ZIP/Postal Code
50047
Country
Ukraine
Facility Name
Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine
City
Kyiv
ZIP/Postal Code
03680
Country
Ukraine
Facility Name
Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine
City
Kyiv
ZIP/Postal Code
04050
Country
Ukraine
Facility Name
Lviv Regional Children Specialized Clinical Hospital
City
Lviv
ZIP/Postal Code
79035
Country
Ukraine
Facility Name
Odesa Regional Children Clinical Hospital
City
Odesa
ZIP/Postal Code
65031
Country
Ukraine
Facility Name
Simferopol Central District Clinical Hospital
City
Simferopol
ZIP/Postal Code
95033
Country
Ukraine
Facility Name
Zaporizhya Regional Clinical Children Hospital
City
Zaporizhya
Country
Ukraine

12. IPD Sharing Statement

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result
Links:
URL
https://www.clinicaltrialsregister.eu/ctr-search/search?query=CMA-0631-PR-0010
Description
Study Record on EU Clinical Trials Register including results

Learn more about this trial

A Single Arm 48-Week Follow-on Safety Study to a Core Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

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