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Completed

NCT Number: NCT01111383

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

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).

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

CHR Clemenceau, Caen, France

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Treatment and study plan

Tobramycin

Drug

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.

Other names: Tobrineb®/Actitob®/Bramitob®

Primary outcomes

  1. 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 outcomes

  1. 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

  2. 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

  3. Changes in body weight and BMI

    Time frame: up to 48 weeks

  4. to assess health related quality of life

    Time frame: Initial visit, Week 20, Week 44

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study 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)

Acronym: CT03Ext

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 27, 2010
Registry last updated
Jul 31, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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