Ease of Use and Microbial Contamination of Tobramycin Inhalation Powder (TIP) Versus Nebulised Tobramycin Inhalation Solution (TIS) and Nebulised Colistimethate (COLI)
Condition: Cystic Fibrosis
MeSH terms: Cystic Fibrosis; Fibrosis
Intervention: Tobramycin Inhalation Powder; Tobramycin inhalation solution; Colistimethate
Intervention description: Tobramycin Inhalation Powder was administered via TOBI® Podhaler (T-326 inhaler).; Tobramycin inhalation solution was administered via nebuliser; Colistimethate was administered via nebuliser.
Intervention MeSH terms: Tobramycin
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Crossover Assignment
Masking: None (Open Label)
Enrollment: 60.0
Sex: All
Minimum age: 6 Years
Healthy volunteers: No
Keywords: Cystic Fibrosis, Pseudomonas aeruginosa, FEV1, tobramycin inhalation powder, TOBI,; colistimethate; Cystic Fibrosis, Pseudomonas aeruginosa, FEV1, tobramycin inhalation powder, TOBI, colistimethate

Summary:

      The purpose of this interventional Phase IV study was to explore the ease of use of TIP and
      prevalence of microbial contamination of the T-326 Inhaler compared with TIS and
      colistimethate administered via nebuliser for the treatment of Cystic Fibrosis (CF) patients
      chronically infected with P. aeruginosa.

      It was anticipated that the data from this study would provide clinicians with further
      guidance on the relative differences between the speed and ease of use of these treatments as
      well as useful information on the prevalence of microbial contamination of the inhalation
      devices in "real world" use.
    

Eligibility criteria:

        Key Inclusion Criteria:

          -  Provide written informed consent, HIPAA authorization, and assent (as appropriate for
             minors) prior to the performance of any study-related procedure

          -  Confirmed diagnosis of Cystic Fibrosis (CF)

          -  Male and female patients 6 years of age or older at screening

          -  Forced Expiratory Volume in 1 second (FEV1) at screening (Visit 1) must be at least
             25% and less than or equal to 90% of normal predicted values for age, sex, and height
             based on the NHANES III values (Hankinson, 1999) for patients 18 years of age or
             greater, and based on values from Wang (Wang 1993) for patients less than 18 years of
             age.

          -  Documented use of any of the nebulized antibiotics based on local practice:

          -  Tobramycin Inhalation Solution, colistimethate, or Tobramycin Inhalation Powder for at
             least 1 cycle within the last 6 months or

          -  Colistimethate continuous use for at least 8 weeks within the last 6 months This cycle
             of treatment (or continuous colistimethate treatment period) is in addition to the
             treatment cycle during which the subject is being screened.

          -  P. aeruginosa must be present in a sputum or deep cough throat swab culture or
             bronchoalveolar lavage (BAL) (only for BAL a threshold level of 10^3 CFU/mL is
             required) within 6 months prior to screening, and in the sputum or deep cough throat
             swab culture at screening or rescreening (Visit 1);

        Key Exclusion Criteria:

          -  History of sputum culture or deep cough throat swab (or BAL) culture yielding
             Burkholderia cenocepacia complex within 2 years prior to prescreening or sputum
             culture yielding B. cenocepacia complex at screening (Visit 1)

          -  History of hearing loss or chronic tinnitus deemed clinically significant by the
             investigator

          -  Serum creatinine 176.8 μmol/L (2 mg/dL) or greater, blood urea nitrogen (BUN) 14.28
             mmol/L (40 mg/dL) or greater, or an abnormal urinalysis defined as 2+ or greater
             proteinuria at screening

          -  Known local or systemic hypersensitivity to aminoglycosides

          -  Regularly receiving more than 1 class of inhaled antipseudomonal antibiotic

          -  Use of any investigational drug within 30 days or 5 half-lives, whichever is longer,
             prior to screening

          -  Signs and symptoms of acute pulmonary disease, e.g., pneumonia, pneumothorax

          -  Body mass index less than 12 kg/m2

          -  History of malignancy of any organ system, treated or untreated

          -  Clinically significant laboratory abnormalities (not associated with the study
             indication) at screening (Visit 1)

          -  Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a
             female after conception and until the termination of gestation, confirmed by a
             positive human chorionic gonadotropin (hCG) laboratory test

          -  Women of child-bearing potential, defined as all women physiologically capable of
             becoming pregnant, unless they are using effective methods of contraception during
             study treatment.