Cystic FibrosisPhase 3CT03 CoreNCT00885365
A Study Comparing the Efficacy and Tolerability of Tobrineb®/Actitob®/Bramitob® Versus TOBI®
A Phase 3 study testing tobramycin / Bramitob and tobramycin / TOBI in people with Cystic Fibrosis, run by Chiesi Farmaceutici S.p.A. at 44 sites in 8 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 6 years and older
- Conditions the study is for
- Cystic Fibrosis
- What is being tested?
- tobramycin / Bramitob and tobramycin / TOBI
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 324 participants
- Where
- 44 sitesin 8 countries
- Study dates
- Apr 2009to May 2010
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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).
Who cannot join
- 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;
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- 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.
Trial locations and contacts
44 sites in 8 countries.
44 sites in 8 countries
Russia10 sites
State Medical Institution: Republican Childrens Clinical Hospital under the Ministry of Health of the Republic of Tatarstan
Kazan', 420138
Federal State Institution: Scientific Research Pulmonology Institute under the Roszdrav
Moscow, 105077
State Medical Institution: Filatov Chidren's City Clinical Hospital #13
Moscow, 123242
Federal State Institution "Nizhegorodskiy Research Institute of Children's Gastroenterology of Russian Medical Technologies"
Nizhny Novgorod, 603950
State Medical Institution: Regional Children's Hospital Pulmonology Department
Rostov-on-Don, 344085
Saint-Petersburg State Medical Institution: City Children's Hospital of Saint Olga
Saint Petersburg, 194156
Regional State Medical Institution: Smolensk Regional Children's Clinical Hospital
Smolensk, 214019
State Higher Educational Institution: Bashkir State Medical University under the Roszdrav
Ufa, 450106
State Higher Educational Institution: Burdenko Voronezh State Medical Academy under the Roszdrav
Voronezh, 394024
Minicipal Medical Institution: Children's Clinical Hospital #1
Yaroslavl, 150003
Poland9 sites
Specjalistyczny ZOZ nad Matka i Dzieckiem, Poradnia Leczenia Mukowiscydozy
Gdansk, 80-308
I Oddzial Chorob Dzieciecych, Wojewodzki Specjalistyczny Szpital Dzieciecy
Kielce, 25-381
Oddzial Kliniczny Interny Dzieciecej i Alergologii, Wojewodzki Szpital Specjalistyczny
Lodz, 93-513
Dzieciecy Szpital Kliniczny Akademii Medycznej, Klinika Chorob Pluc I Reumatologii
Lublin, 20-093
Study site
Multiple Locations
Klinika Pneumonologii, Alergologii Dzieciecej i Immunologii Klinicznej Szpital Kliniczny Uniwersytetu Medycznego w Poznaniu
Poznan, 60-572
Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
Rabka-Zdrój, 34-700
Poradnia Mukowiscydozy Wojewodzkiej, Przychodni Specjalistycznej dla Dzieci, Szpitala Wojewodzkiego Nr 2
Rzeszów, 35-301
Klinika Pediatrii Instytut Matki I Dziecka
Warsaw, 01-211
Ukraine9 sites
Dnipropetrovsk City Children Clinical Hospital # 2
Dnipropetrovsk, 49101
Donetsk Regional Children Clinical Hospital
Donetsk, 83052
Kriviy Rig City Clinical Hospital # 8
Kryvyi Rih, 50047
Institute of Phthysiology and Pulmonology n.a., F.G.Yanovskiy of the Academy of Medical Science of Ukraine
Kyiv, 03680
Institute of Pediatrics, Obstetrics and Gynecology of the Academy of Medical Science of Ukraine
Kyiv, 04050
Lviv Regional Children Specialized Clinical Hospital
Lviv, 79035
Odesa Regional Children Clinical Hospital
Odesa, 65031
Simferopol Central District Clinical Hospital
Simferopol, 95033
Zaporizhya Regional Clinical Children Hospital
Zaporizhya
Spain7 sites
Complejo Hospitalario Universitario A Coruña (Hospital Materno-Infantil Teresa Herrera)
A Coruña, 15006
Complejo Hospitalario Universitario A Coruña
A Coruña, 15006
Hospital Universitario La Paz
Madrid, 28046
Corporació Sanitaria Parc Tauli
Sabadell, 08208
Hospital Universitario Ntra Sra. De la Candelaria
Santa Cruz de Tenerife, 38010
Hospital Universitario La Fe
Valencia, 46009
Hospital Universitario Miguel Servet (Children)
Zaragoza, 50009
France3 sites
CHR Clemenceau
Caen, 14 033
Hopital Arnaud de Villeneuve, Clinique des maladies respiratoires
Montpellier, 34 295
Hopital Necker
Paris, 75 015
Hungary3 sites
Fővárosi Önkormányzat Heim Pál
Budapest, H-1089
Kaposi Mór Oktatókórház
Mosdós, H-7254
Szegedi Tudományegyetem Szent-Györgyi Albert Orvos- és Gyógyszerésztudományi Centrum
Szeged, H6725
Germany2 sites
Pädiatrische Pneumologie und Allergologie, Mukovizidose-Zentrum, Zentrum für Kinderheilkunde und Jugendmedizin
GieBen, 35385
HELIOS Klinikum Krefeld, Zentrum für Kinder- und Jugendmedizin
Krefeld, 47805
Czechia1 site
Centrum pro cystickou fibrosu, Pediatricka klinika UK 2.LF, Fakultní nemocnice v Motole
Prague, 150 06
About this study
Official title: 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
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
- Being tested
- tobramycin / Bramitob, tobramycin / TOBI
- Keywords
- cystic fibrosis, P. aeruginosa, tobramycin
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tobramycin / BramitobDrug
Also called Bramitob, Tobrineb, Actitob, Bethkis
300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen
tobramycin / TOBIDrug
Also called TOBI
300mg/5ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen
| Study group | Role | What they receive |
|---|---|---|
| Bramitob | Experimental | tobramycin / Bramitob administered 300mg twice a day for 4 weeks Receives: Drug: tobramycin / Bramitob |
| TOBI | Active comparator | tobramycin / TOBI administered 300mg twice a day for 4 weeks Receives: Drug: tobramycin / TOBI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal
Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded.
Measured: Day 0 (baseline), Week 4
Secondary outcomes (14)
Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal
Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded. Observed values are summarized (without last observation carry forward).
Measured: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Expiratory Volume in 1 Second (FEV1)
Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Three measurements were collected and the greatest FEV1 value was recorded. Observed values are summarized (without last observation carry forward).
Measured: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline at End of Weeks 2, 4, and 8 of Forced Vital Capacity (FVC) Expressed as Percentage of Predicted Normal
FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured via spirometry. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FVC values for children were different than the reference normal values used with adult participants.
Measured: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Vital Capacity (FVC)
FVC is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. It is measured via spirometry.
Measured: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%), Expressed as Percentage of Predicted Normal
Difference in the forced expiratory flow rate in mid-exhalation as a percent of predicted to standard values measured from baseline to weeks 2 (treated), 4 (treated), and 8 (untreated). Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEF 25-75% values for children were different than the reference normal values used with adult participants.
Measured: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%)
Difference in the forced expiratory flow rate in mid-exhalation measured from baseline to weeks 2 (treated), 4 (treated), and 8 (untreated).
Measured: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline to End of Weeks 4 and 8 in Pseudomonas Aeruginosa Log10 Bacterial Load in Sputum
If a participant had more than one Pseudomonas aeruginosa (PA) morphotype at a given visit, and therefore more than one bacterial load value, then the bacterial load value corresponding to the highest tobramycin minimal inhibitory concentration (MIC) value regardless of the PA morphotype was used. If the tobramycin MIC value was the same for different PA morphotypes, then the bacterial load value corresponding to morphotype 1 (mucoid colony) was used. If morphotype 1 was not available, bacterial load value corresponding to morphotype 2 (dry colony) was used.
Measured: Day -10 to -1 (baseline), Week 4, Week 8
Minimal Inhibitory Concentration Inhibiting Growth of 50% (MIC50) of Pseudomonas Aeruginosa
MIC50 is the concentration of tobramycin required to inhibit 50% of Pseudomonas aeruginosa. MIC values were calculated for three different Pseudomonas aeruginosa (PA) strains:
- Morphotype 1: mucoid
- Morphotype 2: dry
- Morphotype 3: variant
Overall MIC50 values are reported. If a participant has more than one PA morphotype at a given visit, then the highest tobramycin MIC value was used, regardless of PA morphotype. If a participant has more than one available result for each morphotype then the highest tobramycin MIC value was used. If the tobramycin MIC values are equal then the MIC value for the isolate with the highest bacterial load value was used.
Measured: Week 4, Week 8
Minimal Inhibitory Concentration Inhibiting Growth of 90% (MIC90) of Pseudomonas Aeruginosa
MIC90 is the concentration of tobramycin required to inhibit 90% of Pseudomonas aeruginosa. MIC values were calculated for three different Pseudomonas aeruginosa (PA) strains:
- Morphotype 1: mucoid
- Morphotype 2: dry
- Morphotype 3: variant
Overall MIC90 values are reported. If a participant has more than one PA morphotype at a given visit, then the highest tobramycin MIC value was used, regardless of PA morphotype. If a participant has more than one available result for each morphotype then the highest tobramycin MIC value was used. If the tobramycin MIC values are equal then the MIC value for the isolate with the highest bacterial load value was used.
Measured: Week 4, Week 8
Microbiological Outcome Summary by Visit
Microbiological outcomes are derived considering all P. aeruginosa (PA) morphotypes together.
Week 4 and Week 8 microbiological outcomes:
- Eradication = elimination of PA
- Persistence = persistence of PA detected at previous visit
- Superinfection = appearance of a pathogen (other than PA) not detected at previous visit
- Re-infection (week 8 only) = re-appearance of PA detected at Screening and eradicated at Week 4
Superinfection supersedes eradication. Persistence for P. aeruginosa supersedes superinfection.
Re-infection for P. aeruginosa supersedes superinfection.
Measured: Day -10 to -1 (screening), Weeks 4 and 8
Change From Baseline to End of Weeks 2, 4 and 8 in Body Weight
Body weight was measured at all study visits as part of the physical examination.
Measured: Day 0 (baseline), Weeks 2, 4 and 8
Change From Baseline to End of Weeks 2, 4 and 8 in Body Mass Index (BMI)
Measured: Day 0 (baseline), Weeks 2, 4 and 8
Count of Participants With Treatment-Emergent Adverse Events (TEAEs)
Treatment-Emergent Adverse Events defined as adverse events occurring after the first intake of study treatment (or the same day).
The investigator assessed relation to study treatment as a binary question: Reasonable possibility of relatedness or no reasonable possibility of relatedness. The expression "reasonable possibility of relatedness" is meant to convey in general that there are facts (evidence) or arguments meant to suggest a causal relationship.
A serious AE results in death, is life-threatening, requires hospitalization or prolongation of existing inpatient hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly/birth defect or an important medical event.
The investigator rates the severity of the AE based on a three point scale: mild, moderate or severe. A severe event prevents any usual routine activity of the participant and causes severe discomfort.
Measured: Day 0 to Week 8
Participants With a Hearing Threshold >20 Decibel in at Least One Ear
The potential ototoxic effects (hearing loss) of tobramycin were investigated by performing audiometric tests. Participants with a loss of auditory acuity greater than the 20 decibels auditory threshold are reported.
Measured: Day -10 to -1 (screening), Weeks 4 and 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2010
- Study completionMay 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cystic FibrosisStudies of the same condition, open and under way.
- More trials run by Chiesi Farmaceutici S.p.A.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 324 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chiesi Farmaceutici S.p.A.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Henryk Mazurek, Doctor, Principal investigator, Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885365
- Sponsor's protocol ID
- CMA-0631-PR-0010 Core
- Acronym
- CT03 Core
- Status last verified
- Apr 2018
- First submitted
- 20 Apr 2009
- Last updated
- 27 Jun 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 24464974
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT00885365
- Acronym / sponsor ID
- CT03 Core / CMA-0631-PR-0010 Core
- Conditions
- Cystic Fibrosis
- Keywords
- cystic fibrosis, P. aeruginosa, tobramycin
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 324 participants (actual)
- Lead sponsor
- Chiesi Farmaceutici S.p.A.Industry (pharma, biotech, devices)
- Study start
- Apr 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- May 2010 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Posted 20 Jun 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bramitob | Experimental | Drug: tobramycin / Bramitobtobramycin / Bramitob administered 300mg twice a day for 4 weeks |
| TOBI | Active comparator | Drug: tobramycin / TOBItobramycin / TOBI administered 300mg twice a day for 4 weeks |
Who may qualify
- Ages
- 6 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (7 listed)
- 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;
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tobramycin / BramitobAlso: Bramitob, Tobrineb, Actitob, Bethkis300mg/4ml solution, via a nebuliser, over a 4-week treatment in a twice-daily regimen | Drug | Bramitob |
| tobramycin / TOBIAlso: TOBI300mg/5ml solution administered via nebuliser, over a 4-week treatment in a twice-daily regimen | Drug | TOBI |
Primary outcome
Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal
Time frame: Day 0 (baseline), Week 4
Pulmonary function measurements were performed by using a self-calibrated computer-operated pneumotochographic spirometer at all clinic visits. Because this study included both adults and children and lung volume is an age-dependent variable, reference normal FEV1 values for children were different than the reference normal values used with adult participants. Three measurements were collected and the greatest FEV1 value was recorded.
14 secondary outcomes
Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal
Time frame: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Expiratory Volume in 1 Second (FEV1)
Time frame: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline at End of Weeks 2, 4, and 8 of Forced Vital Capacity (FVC) Expressed as Percentage of Predicted Normal
Time frame: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline to End of Weeks 2, 4, and 8 of Absolute Forced Vital Capacity (FVC)
Time frame: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%), Expressed as Percentage of Predicted Normal
Time frame: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline to End of Weeks 2, 4, and 8 of Forced Expiratory Flow at 25-75% of Vital Capacity (FEF 25-75%)
Time frame: Day 0 (baseline), Week 2, Week 4, Week 8
Change From Baseline to End of Weeks 4 and 8 in Pseudomonas Aeruginosa Log10 Bacterial Load in Sputum
Time frame: Day -10 to -1 (baseline), Week 4, Week 8
Minimal Inhibitory Concentration Inhibiting Growth of 50% (MIC50) of Pseudomonas Aeruginosa
Time frame: Week 4, Week 8
Minimal Inhibitory Concentration Inhibiting Growth of 90% (MIC90) of Pseudomonas Aeruginosa
Time frame: Week 4, Week 8
Microbiological Outcome Summary by Visit
Time frame: Day -10 to -1 (screening), Weeks 4 and 8
Change From Baseline to End of Weeks 2, 4 and 8 in Body Weight
Time frame: Day 0 (baseline), Weeks 2, 4 and 8
Change From Baseline to End of Weeks 2, 4 and 8 in Body Mass Index (BMI)
Time frame: Day 0 (baseline), Weeks 2, 4 and 8
Count of Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day 0 to Week 8
Participants With a Hearing Threshold >20 Decibel in at Least One Ear
Time frame: Day -10 to -1 (screening), Weeks 4 and 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 24464974Mazurek 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.
- Study Record on EU Clinical Trials Register including resultsLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Henryk Mazurek, Doctor principal investigator
Klinika Pneumonologii i Mukowiscydozy, Instytut Gruzlicy i Chorob Pluc w Rabce Zdroj
44 sites in 8 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tobramycin / Bramitob and tobramycin / TOBI in people with Cystic Fibrosis, run by Chiesi Farmaceutici S.p.A. at 44 sites in 8 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 44 sites in Russia, Poland, Ukraine, Spain, France and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 20 Jun 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline to End of the Treatment Period of Forced Expiratory Volume in 1 Second (FEV1), Expressed as Percentage of Predicted Normal (time frame: Day 0 (baseline), Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00885365, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jun 2018.