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

• Sponsor: Chiesi Farmaceutici S.p.A. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT01111383
• Collaborator: (none)
• Enrollment: 209
• Locations: 20
• Duration (Months): 19.9
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.5

Study Details

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).

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis	Drug: tobramycin	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 209 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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 Start Date: Sep 1, 2009
• Actual Primary Completion Date: May 1, 2011
• Actual Study Completion Date: May 1, 2011

Outcome Measures

Primary Outcome Measures

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. [up to 48 weeks]

Secondary Outcome Measures

1. to assess whether prolonged use of aerosolized tobramycin is required to sustain FEV1 increase (FEV1 expressed in liters and % predicted) [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) [up to 48 weeks]

3. Changes in body weight and BMI [up to 48 weeks]

4. to assess health related quality of life [Initial visit, Week 20, Week 44]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Successful completion of Core Study

• At least 6 years of age

• Males and females

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHR Clemenceau	Caen		France	14 033
2	Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires	Montpellier		France	34 295
3	Hopital Necker	Paris		France	75 015
4	Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy	Gdansk		Poland	80-308
5	I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy	Kielce		Poland	25-381
6	Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny	Lodz		Poland	93-513
7	Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii	Lublin		Poland	20-093
8	Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu	Poznan		Poland	60-572
9	Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj	Rabka Zdroj		Poland	34-700
10	Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2	Rzeszow		Poland	35-301
11	Klinika Pediatrii Instytut Matki I Dziecka	Warszawa		Poland	01-211
12	Dnipropetrovsk City Children Clinical Hospital # 2	Dnipropetrovsk		Ukraine	49101
13	Donetsk Regional Children Clinical Hospital	Donetsk		Ukraine	83052
14	Kriviy Rig City Clinical Hospital # 8	Kriviy Rig		Ukraine	50047
15	Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine	Kyiv		Ukraine	03680
16	Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine	Kyiv		Ukraine	04050
17	Lviv Regional Children Specialized Clinical Hospital	Lviv		Ukraine	79035
18	Odesa Regional Children Clinical Hospital	Odesa		Ukraine	65031
19	Simferopol Central District Clinical Hospital	Simferopol		Ukraine	95033
20	Zaporizhya Regional Clinical Children Hospital	Zaporizhya		Ukraine

Sponsors and Collaborators

• Chiesi Farmaceutici S.p.A.

Investigators

• Principal Investigator: Henryk Mazurek, Doctor, Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• Study Record on EU Clinical Trials Register including results

Publications

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• Boat TF, Welsh MJ, Beaudet AL. Cystic fibrosis, in the metabolic basis of inherited disease (7th edn). McGraw-Hill, New York,1995.
• Bossi A, Battistini F, Braggion C, Magno EC, Cosimi A, de Candussio G, Gagliardini R, Giglio L, Giunta A, Grzincich GL, La Rosa M, Lombardo M, Lucidi V, Manca A, Mastella G, Moretti P, Padoan R, Pardo F, Quattrucci S, Raia V, Romano L, Salvatore D, Taccetti G, Zanda M. [Italian Cystic Fibrosis Registry: 10 years of activity]. Epidemiol Prev. 1999 Jan-Mar;23(1):5-16. Italian.
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• Quanjer PH, Tammeling GJ, Cotes JE, Pedersen OF, Peslin R, Yernault JC. Lung volumes and forced ventilatory flows. Report Working Party Standardization of Lung Function Tests, European Community for Steel and Coal. Official Statement of the European Respiratory Society. Eur Respir J Suppl. 1993 Mar;16:5-40. Review.
• Ramsey BW, Dorkin HL, Eisenberg JD, Gibson RL, Harwood IR, Kravitz RM, Schidlow DV, Wilmott RW, Astley SJ, McBurnie MA, et al. Efficacy of aerosolized tobramycin in patients with cystic fibrosis. N Engl J Med. 1993 Jun 17;328(24):1740-6.
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• Responsible Party: Chiesi Farmaceutici S.p.A.
• ClinicalTrials.gov Identifier: NCT01111383
• Other Study ID Numbers: CMA-0631-PR-0010 Extension
• First Posted: Apr 27, 2010
• Last Update Posted: Jul 31, 2020
• Last Verified: Jul 1, 2020

• Keywords provided by Chiesi Farmaceutici S.p.A.: cystic fibrosis; P. aeruginosa; tobramycin
• Additional relevant MeSH terms: Cystic Fibrosis; Fibrosis; Tobramycin

Study Results

No Results Posted as of Jul 31, 2020