Clinical trial NCT01069705: Second Open Label Extension to Bridging Study CTBM100C2303
Official title: A Phase III Open-Label Extension Study to Assess the Safety and Efficacy of Tobramycin Inhalation Powder After Manufacturing Process Modifications (TIPnew) in Cystic Fibrosis (CF) Patients Who Successfully Completed Participation in Study CTBM100C2303E1
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pulmonary Infections
Pseudomonas Aeruginosa
Keywords: Tobramycin Inhalation Powder
Cystic fibrosis
Lung diseases
Anti-Bacterial Agents
Treatment of pulmonary infections with P. aeruginosa in cystic fibrosis participants
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2010-02-17
Enrollment: 49
Sex: ALL
Minimum age (years): 6
Maximum age (years): 21
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This was an open-label, single arm (uncontrolled) study in participants suffering from cystic fibrosis, who have completed their study participation in CTBM100C2303 and extension study one CTBM100C2303E1 (all visits), who were proven infected with Pseudomonas aeruginosa at enrollment into CTBM100C2303.


Eligibility criteria: Inclusion Criteria:

* Completed all visits in study CTBM100C2303 and CTBM100C2303E1, and visit 11 of study CTBM100C2303E1 took place not more than 5 days before enrollment into this study.
* Confirmed diagnosis of cystic fibrosis participants with P. aeruginosa infection.
* Forced Expiratory Volume in one second (FEV1) at screening (at start of study CTBM100C2303) must be between 25% and 80% of normal predicted values.

Exclusion Criteria:

* Any use of inhaled anti-pseudomonal antibiotics between the termination of the trial CTMB100C2303E1 and the enrollment into this study.
* Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.

Primary outcomes:
measure: Number of Participants With Adverse Events (AEs)
timeFrame: From time of first administration of study drug until study completion (up to 169 days)
measure: Number of Participants With Serious Adverse Events (SAEs)
timeFrame: From time of consent to 4 weeks after study completion (up to 199 days)
measure: Percentage of Participants With a Decrease of ≥20% in Forced Expiratory Value in One Second (FEV1) Percent (%) Predicted From Pre-dose to 30-minute Post-dose
timeFrame: Pre-dose and post-dose of Day 1 and Day 29 of every Cycle (5, 6, 7)
measure: Percentage of Participants With Frequency Decrease From Baseline in the Post-baseline Audiology Tests
timeFrame: Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
Secondary outcomes:
measure: Relative Change From Baseline of Forced Expiratory Volume in One Second (FEV1) Percent Predicted to Each Post-baseline Visit
timeFrame: Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
measure: Relative Change From Baseline of Forced Vital Capacity (FVC) Percent Predicted to Each Post-baseline Visit
timeFrame: Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
measure: Relative Change From Baseline of Forced Expiratory Flow Rate Over 25 and 75 Percent (FEF25-75%) Predicted to Each Post-baseline Visit
timeFrame: Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
measure: Change From Baseline in Pseudomonas Aeruginosa Sputum Density to Each Post-baseline Visit
timeFrame: Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
measure: Change From Baseline in Tobramycin Minimum Inhibitory Concentration (MIC) Values for Pseudomonas Aeruginosa to Each Post-baseline Visit
timeFrame: Baseline, Cycles 5, 6, 7 (Days 1, 29) and Follow-up (Week 57/Day 57)
measure: Number of Participants Who Used New Antipseudomonal Antibiotic During Treatment Period
timeFrame: Baseline, Cycles 5, 6, 7 (Days 1, 29)
measure: Percentage of Participants With Hospitalization Due to Respiratory Serious Adverse Events (SAEs)
timeFrame: From time of consent to 4 weeks after study completion (up to 199 days)
measure: Number of Days of Hospitalization Due to Respiratory Serious Adverse Events (SAEs)
timeFrame: From time of consent to 4 weeks after study completion (up to 199 days)
Other outcomes:
Locations:
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Plovdiv
country: Bulgaria
facility: Novartis Investigative Site
city: Sofia
country: Bulgaria
facility: Novartis Investigative Site
city: Varna
country: Bulgaria
facility: Novartis Investigative Site
city: Tallin
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Timisoara
country: Romania
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Samara
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Durban
country: South Africa
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Konstan MW, Flume PA, Galeva I, Wan R, Debonnett LM, Maykut RJ, Angyalosi G. One-year safety and efficacy of tobramycin powder for inhalation in patients with cystic fibrosis. Pediatr Pulmonol. 2016 Apr;51(4):372-8. doi: 10.1002/ppul.23358. Epub 2015 Dec 27.