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Completed

NCT Number: NCT01519661

Long Term Safety of Tobramycin Inhalation Powder in Patients With Cystic Fibrosis

This study assessed the long term safety data for the use of tobramycin inhalation powder in patients suffering from cystic fibrosis who have a chronic pulmonary infection with Pseudomonas aeruginosa.

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Key information

Conditions

Pulmonary Infections Congenital, Hereditary, and Neonatal Diseases and Abnormalities Cystic Fibrosis Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Pseudomonas Aeruginosa in Cystic Fibrosis Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Investigative Site, Caba, Buenos Aires, Argentina

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Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Confirmed diagnosis of Cystic Fibrosis
  • FEV1 at screening must be between 25 and 75 percent of normal predicted values for age, sex and height based on the Knudson equation
  • Pseudomonas aeruginosa must be present in a sputum / deep cough throat swab culture or bronchoalveolar lavage within 6 months prior to screening and in the sputum/deep-throat cough swab culture at screening

Exclusion criteria

  • History of sputum culture or deep cough throat swab culture yielding Burkholderia cenocepacia complex within 2 years prior to screening and /or sputum culture yielding Burkholderia cenocepacia at screening
  • Hemoptysis more than 60mL at any time within 30 days prior to study drug administration
  • History of hearing loss or chronic tinnitus deemed clinically significant
  • Serum creatinine 2mg/dl or more, BUN 40mg/dl or more, or an abnormal urinalysis defined as 2+ or greater proteinuria at screening
  • Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics
  • Patients who are regularly receiving more than 1 class of inhaled anti-pseudomonal antibiotic
  • Any use of inhaled or systemic anti-pseudomonal antibiotic within 28 days prior to study drug administration
  • Use of loop diuretics within 7 days prior to study drug administration

Other protocol-defined inclusion/exclusion criteria may apply.

Treatment and study plan

TBM100

Drug

Tobramycin inhalation powder was assigned as four capsules at 28mg dosage strength. It was inhaled b.i.d in the morning and in the evening via the T-326 Inhaler.

Primary outcomes

  1. Percentage of Participants With Treatment Emergent Adverse Events, Serious Adverse Events (SAEs) and Deaths

    Time frame: 337 days

    Adverse events were deemed treatment-emergent if the onset date/time was on or after the date and time of first study drug. All adverse events were included after this time during both on and off-treatment periods.

Secondary outcomes

  1. Relative Change From Baseline in Forced Expiratory Volume in One Second (FEV1) Percent Predicted

    Time frame: Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.

    Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEV1 % predicted from baseline to pre-dose day X = ((pre-dose day X FEV1 % predicted - baseline FEV1 % predicted) / baseline FEV1 % predicted) • 100.

  2. Relative Change From Baseline in FVC Percent Predicted

    Time frame: Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.

    Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recorded at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FVC % predicted from baseline to pre-dose day X = ((pre-dose day X FVC % predicted - baseline FVC % predicted) / baseline FVC % predicted) • 100.

  3. Relative Change From Baseline in FEF Rate Over 25 to 75 Percent of Vital Capacity Predicted

    Time frame: Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337. All study visits except baseline and day 337 occurred at the end of a 28-day on-treatment period of a cycle. Day 337 was the end of the final 28-day off treatment period.

    Spirometry was performed at each visit. FEV1, FVC, and FEF25-75 were recored at all visits according to American Thoracic Society (ATS) guidelines. FEV1 = the volume of air expired in 1 second. FEV1 % predicted is a normalized value of FEV1 calculated using the Knudsen equation, based upon participant's age, gender and height. FVC (forced vital capacity) = the maximal volume of air exhaled with maximally forced effort from a position of maximal inspiration. FEF25-75 = forced expiratory flow from 25% to 75% of the FVC. Relative change in FEEF25-75 from baseline to pre-dose day X = ((pre-dose day X FEF25-75 - baseline FEF25-75) / baseline FEF25-75) • 100.

  4. Change From Baseline in Pseudomonas Aeruginosa Colony Forming Units in Sputum

    Time frame: Baseline, day 1, day 29, day 85, day 141, day 197, day 253, day 309, day 337

    Sputum was collected in sterile containers and cultured for Pseudomonas aeruginosa (Pa.) (quantitative test) and other typical Cystic Fibrosis respiratory pathogens. The Pa. biotypes measured were mucoid, dry and small colony variant. Results are presented for the sum of all biotypes of Pa, with data transformed using a base 10 logarithm.

  5. Tobramycin MIC 50 and MIC 90 Values Over All Isolates for the Sum of All Biotypes (Mucoid, Dry and Small Colony Variant) of Pseudomonas Aeruginosa

    Time frame: Baseline, day 29, day 85, day 141, day 197, day 253, day 309, day 337

    Tobramycin MIC 50 and MIC 90 values were defined as the lowest concentration of tobramycin required to inhibit 50% and 90%, respectively, of the P. aeruginosa strains tested.

  6. Percentage of Participants Hospitalized Due to Serious Respiratory-related Adverse Events

    Time frame: Day 337

  7. Number of Hospitalization Days Due to Serious Respiratory-related Adverse Events

    Time frame: Day 337

    The total number of hospitalization days due to serious respiratory-related adverse events was analyzed.

  8. Time to First Hospitalization Due to Serious Respiratory-related Adverse Events

    Time frame: Day 337

    The day of first hospitalization due to serious respiratory-related adverse events was analyzed.

  9. Percentage of Participants Who Used New Anti-pseudomonal Antibiotics

    Time frame: Day 337

  10. Number of Days of New Anti-pseudomonal Antibiotic Use

    Time frame: Day 337

    The total number of days of new anti-pseudomonal antibiotic use was analyzed.

  11. Time to Use of New Anti-pseudomonal Antibiotic

    Time frame: Day 337

    Time to first use of new anti-pseudomonal antibiotic was analyzed.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Single Arm, Open-label, Multicenter, Phase IV Trial to Assess Long Term Safety of Tobramycin Inhalation Powder (TIP) in Patients With Cystic Fibrosis

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 27, 2012
Registry last updated
Feb 10, 2015

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

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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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