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

Cystic Fibrosis Clinical Trial

— 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01111383
• Other study ID #: CMA-0631-PR-0010 Extension
• Status: Completed
• Phase: Phase 3
• Start date: September 2009
• Est. completion date: May 2011

Study information

• Verified date: July 2020
• Source: Chiesi Farmaceutici S.p.A.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 209
• Est. completion date: May 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

• Successful completion of Core Study

• At least 6 years of age

• Males and females

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Drug:
• tobramycin
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.

Locations

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

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

France,  Poland,  Ukraine, 

References & Publications (29)

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* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.		up to 48 weeks
Secondary	to assess whether prolonged use of aerosolized tobramycin is required to sustain FEV1 increase (FEV1 expressed in liters and % predicted)		up to 48 weeks
Secondary	Categorical results of microbiological tests referred to P. aeruginosa (negativisation, persistence, superinfection, re-infection); susceptibility testing of isolated P. aeruginosa strains (MIC90 and MIC50)		up to 48 weeks
Secondary	Changes in body weight and BMI		up to 48 weeks
Secondary	to assess health related quality of life		Initial visit, Week 20, Week 44

External Links

•   Study Record on EU Clinical Trials Register including results