A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®

NCT ID: NCT00885365

Last Updated: 2018-06-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 324 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-04-30
• Study Completion Date: 2010-05-31

Brief Summary

The objectives of the study are to demonstrate that Tobrineb®/Actitob®/Bramitob® is non-inferior to TOBI® in the primary efficacy variable, forced expiratory volume in one second (FEV1) percent of predicted normal, and to compare the safety in participants with cystic fibrosis and chronic infection of the lungs with Pseudomonas aeruginosa.

Conditions

Cystic Fibrosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bramitob

tobramycin / Bramitob administered 300mg twice a day for 4 weeks

Group Type: EXPERIMENTAL

tobramycin / Bramitob

Intervention Type: DRUG

300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen

TOBI

tobramycin / TOBI administered 300mg twice a day for 4 weeks

Group Type: ACTIVE_COMPARATOR

tobramycin / TOBI

Intervention Type: DRUG

300mg/5ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen

Interventions

tobramycin / Bramitob

300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen

Intervention Type: DRUG

tobramycin / TOBI

300mg/5ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen

Intervention Type: DRUG

Other Intervention Names

Bramitob; Tobrineb; Actitob; Bethkis; TOBI

Eligibility Criteria

Inclusion Criteria

• Patients of either sex aged ≥ 6;
• Clinical diagnosis of cystic fibrosis defined as: (1)Patients preferably registered in the National Registry of CF (or other documents depending on country legislation); (2) Evidence of two or more typical pulmonary clinical features observed in CF, e.g., persistent colonization/infection with typical CF pathogens, chronic cough and sputum production, persistent chest radiography abnormalities, airway obstruction, nasal polyps and/or digital clubbing;
• Positive response in the standard sweat test (sweat chloride concentration ≥ 60 mmol/l for the standard method or ≥ 80 mmol/L for a microduct technique) documented in the clinical records and/or gene mutation documented in the clinical records;
• Chronic colonization of P. aeruginosa: presence in a sputum or throat culture of a minimum of 2 positive samples for P. aeruginosa over the previous 12 months and/or presence of more than two precipitating antibodies against P. aeruginosa;
• Sputum containing P. aeruginosa susceptible to tobramycin (defined as a zone diameter ≥ 16 mm after testing with 10 µg tobramycin disk or as a minimal inhibition concentration based on microdilution testing system) as identified by local laboratory at screening visit;
• Forced expiratory volume in 1 sec (FEV₁) ≥ 40% and ≤ 80% of the predicted normal value;
• Written informed consent obtained by parents/legal representative according to local regulations) and by the patient (when appropriate).

Exclusion Criteria

• Administration of antipseudomonal antibiotic therapy by any route in the previous 4 weeks;
• Evidence of impaired renal function (serum creatinine level ≥ 1.5 mg/dl);
• Evidence of impaired auditory function (auditory threshold in either ear above 20 dB at frequencies between 250 and 8000Hz);
• Sputum culture containing Burkholderia cepacia;
• Patients with end-stage lung disease, candidates for heart-lung transplantation;
• History of other clinically significant cardiac, renal, neurological, gastrointestinal, hepatic or endocrine disease related to cystic fibrosis, whose sequelae and/or treatment can interfere with the results of the present study;
• Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e., contraceptive methods other than rod containing a hormone that prevents user from getting pregnant and that will be placed under the skin, syringes that contain a contraceptive hormone, combined birth control pill, i.e., such that contains two hormones, some intrauterine devices (IUDs) and sexual abstinence). A pregnancy test in urine is to be carried out in women of a fertile age at screening and at the last clinic visit;
• Known hypersensitivity to aminoglycosides;
• Patients with evidence of alcohol or drug abuse, likely to be not compliant with the study protocol or likely to be not compliant with the study treatments;
• Participation in another clinical trial with an investigational drug in the four weeks preceding the screening visit.

• Minimum Eligible Age: 6 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chiesi Farmaceutici S.p.A.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Henryk Mazurek, Doctor

Role: PRINCIPAL_INVESTIGATOR

Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj

Locations

Centrum pro cystickou fibrosu, Pediatricka klinika UK 2.LF, Fakultní nemocnice v Motole

Prague, , Czechia

CHR Clemenceau

Caen, , France

Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires

Montpellier, , France

Hopital Necker

Paris, , France

Pädiatrische Pneumologie und Allergologie, Mukovizidose-Zentrum, Zentrum für Kinderheilkunde und Jugendmedizin

GieBen, , Germany

HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin

Krefeld, , Germany

Fővárosi Önkormányzat Heim Pál

Budapest, , Hungary

Kaposi Mór Oktatókórház

Mosdós, , Hungary

Szegedi Tudományegyetem Szent-Györgyi Albert Orvos- és Gyógyszerésztudományi Centrum

Szeged, , Hungary

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

Multiple Locations, , 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-Zdrój, , Poland

Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2

Rzeszów, , Poland

Klinika Pediatrii Instytut Matki I Dziecka

Warsaw, , Poland

State Medical Institution: Republican Childrens Clinical Hospital under the Ministry of Health of the Republic of Tatarstan

Kazan', , Russia

Federal State Institution: Scientific Research Pulmonology Institute under the Roszdrav

Moscow, , Russia

State Medical Institution: Filatov Chidren's City Clinical Hospital #13

Moscow, , Russia

Federal State Institution "Nizhegorodskiy Research Institute of Children's Gastroenterology of Russian Medical Technologies"

Nizhny Novgorod, , Russia

State Medical Institution: Regional Children's Hospital Pulmonology Department

Rostov-on-Don, , Russia

Saint-Petersburg State Medical Institution: City Children's Hospital of Saint Olga

Saint Petersburg, , Russia

Regional State Medical Institution: Smolensk Regional Children's Clinical Hospital

Smolensk, , Russia

State Higher Educational Institution: Bashkir State Medical University under the Roszdrav

Ufa, , Russia

State Higher Educational Institution: Burdenko Voronezh State Medical Academy under the Roszdrav

Voronezh, , Russia

Minicipal Medical Institution: Children's Clinical Hospital #1

Yaroslavl, , Russia

Complejo Hospitalario Universitario A Coruña (Hospital Materno-Infantil Teresa Herrera)

A Coruña, , Spain

Complejo Hospitalario Universitario A Coruña

A Coruña, , Spain

Hospital Universitario La Paz

Madrid, , Spain

Corporació Sanitaria Parc Tauli

Sabadell, , Spain

Hospital Universitario Ntra Sra. De la Candelaria

Santa Cruz de Tenerife, , Spain

Hospital Universitario La Fe

Valencia, , Spain

Hospital Universitario Miguel Servet (Children)

Zaragoza, , Spain

Dnipropetrovsk City Children Clinical Hospital # 2

Dnipropetrovsk, , Ukraine

Donetsk Regional Children Clinical Hospital

Donetsk, , Ukraine

Kriviy Rig City Clinical Hospital # 8

Kryvyi Rih, , Ukraine

Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine

Kyiv, , Ukraine

Institute of Pediatrics, Obstetrics and Gynecology 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, , Ukraine

Countries

Czechia; France; Germany; Hungary; Poland; Russia; Spain; Ukraine

References

Mazurek H, Chiron R, Kucerova T, Geidel C, Bolbas K, Chuchalin A, Blanco-Aparicio M, Santoro D, Varoli G, Zibellini M, Cicirello HG, Antipkin YG. Long-term efficacy and safety of aerosolized tobramycin 300 mg/4 ml in cystic fibrosis. Pediatr Pulmonol. 2014 Nov;49(11):1076-89. doi: 10.1002/ppul.22989. Epub 2014 Jan 24.

Reference Type: RESULT

PMID: 24464974 (View on PubMed)

Related Links

https://www.clinicaltrialsregister.eu/ctr-search/search?query=CMA-0631-PR-0010

Study Record on EU Clinical Trials Register including results

Other Identifiers

CMA-0631-PR-0010 Core

Identifier Type: -

Identifier Source: org_study_id