Phase 3
Completed N=517
Safety of Tobramycin Inhalation Powder (TIP) vs Tobramycin Solution for Inhalation in Patients With Cystic Fibrosis
Source: ClinicalTrials.gov NCT00388505 ↗Enrolled (actual)
517
Serious AEs
28.2%
Results posted
Jul 2012
Primary outcomePrimary: Number of Participants With Treatment-emergent Adverse Events — 278; 176; 85; 61 participants
Summary
This study compares the safety of the tobramycin solution for inhalation with the tobramycin dry powder formulation, used with a simple inhaler
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Participants With Treatment-emergent Adverse Events |
278; 176; 85; 61; 3; 0 | — |
| SECONDARY Serum Tobramycin Concentrations |
0.00; 0.02; 0.82; 0.61; 0.74; 0.69 | — |
| SECONDARY Percentage of Participants With a Decrease From Baseline in Auditory Acuity |
13.3; 10.3; 12.7; 0.0; 18.5; 11.8 | — |
| SECONDARY Relative Change From Baseline in Percent Predicted Forced Expiratory Volume in One Second (%FEV1) |
52.9; 52.8; 2.8; 3.6; 2.3; 4.3 | — |
| SECONDARY Patient Satisfaction Assessed Using the Treatment Satisfaction Questionnaire for Medication |
74.1; 64.6; 92.1; 92.4; 82.3; 58.1 | — |
| SECONDARY Change From Baseline in Pseudomonas Aeruginosa Sputum Density |
7.23; 7.35; -1.76; -1.32; -1.54; -1.11 | — |
| SECONDARY Change From Baseline in Tobramycin Minimum Inhibitory Concentration |
35.39; 42.45; 38.47; 5.80; 35.59; 20.68 | — |
| SECONDARY Antipseudomonal Antibiotic Usage During the Study |
34.5; 40.1 | — |
| SECONDARY Hospitalization Due to Respiratory Events During the Study |
15.6; 15.3 | — |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00388505). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.