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Completed

NCT Number: NCT00388505

Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis

This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

6 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Novartis Investigative Site, South Brisbane, Australia

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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
  • Male and female patients at least 6 years of age at the time of screening.
  • Forced expiratory volume in one second (FEV1) at screening must be at least 25% and less than or equal to 75% of normal predicted values for age, sex, and height based on Knudson criteria.
  • Pseudomonas aeruginosa, a type of bacteria, must be present in a sputum/deep-throat cough swab culture (or bronchoalveolar lavage [BAL]) within 6 months prior to screening and in the sputum/ deep-throat cough swab culture at the screening visit.
  • Able to comply with all protocol requirements.
  • Clinically stable in the opinion of the investigator.
  • Use of an effective means of contraception in females of childbearing potential.
  • Provide written informed consent, Health Authority Portability and Accountability Act (HIPAA) authorization (where applicable), and assent (as appropriate) prior to the performance of any study-related procedure.

Exclusion criteria

  • History of sputum culture or deep-throat cough swab (or BAL) culture yielding Burkholderia cepacia (B cepacia), a type of bacteria, within 2 years prior to screening and/or sputum culture yielding B cepacia at screening.
  • Coughing up more than 60 cc of blood from the respiratory tract at any time within 30 days prior to study drug administration.
  • Known local or systemic hypersensitivity to aminoglycosides or inhaled antibiotics.
  • Females who are pregnant (positive pregnancy test), lactating, or are planning to become pregnant during the study.
  • History of hearing loss or chronic ringing in the ears deemed clinically significant by the investigator.
  • Use of systemic or inhaled antipseudomonal antibiotics within 28 days prior to study drug administration.
  • Use of loop diuretics within 7 days prior to study drug administration.
  • Use of any investigational treatment within 28 days prior to study drug administration.
  • Initiation of treatment with chronic macrolide therapy, dornase alpha treatment or inhaled corticosteroids within 28 days prior to study drug administration (patients may be taking these therapies at the time of enrollment, but they must have initiated treatment more than 28 days prior to study drug administration).

Other protocol-defined inclusion/exclusion criteria may apply

Treatment and study plan

Tobramycin Inhalation Powder

Drug

Tobramycin Inhalation Powder (TIP) capsules for inhalation.

Tobramycin Solution for Inhalation

Drug

Tobramycin solution for inhalation (TOBI), supplied as 300 mg/5mL ampoules administered with a nebulizer

Primary outcomes

  1. Number of Participants With Treatment-emergent Adverse Events

    Time frame: 25 weeks

    An adverse event (AE) is any untoward medical occurrence, including any unfavorable and unintended sign, symptom or disease temporally associated with the use of the study medication that does not necessarily have a causal relationship with study medication. A serious AE (SAE) is an event that results in death, is life-threatening, requires or prolongs inpatient hospitalization, results in persistent or significant disability, is a congenital anomaly or defect, or is a significant medical event that may jeopardize the patient or require intervention to prevent one of the outcomes listed above.

Secondary outcomes

  1. Serum Tobramycin Concentrations

    Time frame: Weeks 1, 5, 17 and 21

    Serum tobramycin concentrations were measured in a subset of participants at Week 1 (start of cycle 1), Week 5 (End of Cycle 1), Week 17 (start of cycle 3) and Week 21 (end of cycle 3). Serum samples were collected at pre-dose and post-dose at specified intervals; one specimen between 0 to 2 hours; two additional specimens between 2 and 5 hours (sample times must have been a minimum of 2 hours apart).

  2. Percentage of Participants With a Decrease From Baseline in Auditory Acuity

    Time frame: Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21)

    Audiology testing was performed only at selected centers. Auditory acuity was measured from 250 to 8000 Hertz using a standard dual-channel audiometer.

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

    Time frame: Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)

    Forced expiratory volume in one second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation. FEV1 is then converted to a percentage of normal (percent predicted) based on height, weight, and race. FEV1 was measured at Baseline (prior to beginning study treatment) and predose on Day 28 of Cycles 1, 2 and 3 and at the follow-up visit.

    Relative change = 100 * ((Day 28 of Cycle 3 value - Baseline value)/ Baseline value).

  4. Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication

    Time frame: Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21).

    Patient's self-reported treatment satisfaction was measured using the Treatment Satisfaction Questionnaire for Medication (TSQM, a validated instrument) which was modified by adding four study-specific questions; the standard fourteen questions of the TSQM were not altered. Responses to nearly all items are rated on a five-point or seven-point rating scale and the items are factored into 4 domains. The TSQM domain scores range from 0 to 100 with higher scores representing higher satisfaction for that domain.

  5. Change From Baseline in Pseudomonas Aeruginosa Sputum Density

    Time frame: Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25).

    Three Pseudomonas aeruginosa biotypes were assessed in patient's sputum; mucoid, dry and small colony variant. Overall density is defined as the sum of all bio-types in Pseudomonas aeruginosa density.

  6. Change From Baseline in Tobramycin Minimum Inhibitory Concentration

    Time frame: Baseline and Day 28 of Cycles 1, 2 and 3 (Weeks 5, 13 and 21) and Final Visit (Week 25)

    The minimum inhibitory concentration (MIC) is the lowest concentration of an antimicrobial that will inhibit the visible growth of a microorganism after overnight incubation. The MIC of tobramycin against total Pseudomonas aeruginosa colonization was assessed over the course of the study.

  7. Antipseudomonal Antibiotic Usage During the Study

    Time frame: 25 Weeks

    The average number of days patients required antipseudomonal antibiotics during the course of the study.

  8. Hospitalization Due to Respiratory Events During the Study

    Time frame: 25 Weeks

    The average number of days patients were hospitalized due to respiratory events during the course of the study.

Sponsors and collaborators

Lead sponsor

Novartis Pharmaceuticals

Industry

Registry information

Official study title

A Randomized, Open-label Multicentre Phase 3 Trial to Assess the Safety of Tobramycin Inhalation Powder Compared to Tobramycin Solution for Inhalation in Cystic Fibrosis Subjects

Acronym: EAGER

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Oct 17, 2006
Registry last updated
Jul 24, 2012

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

View the official ClinicalTrials.gov record (opens in a new tab)

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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