Trial Outcomes & Findings for Efficacy of TOBI Podhaler vs. Tobramycin Inhalation Solution (NCT NCT02038803)

NCT ID: NCT02038803

Last Updated: 2024-12-06

Results Overview

Number of Participants with Adherence to Tobramycin Inhaled Solution Treatment compared with TOBI Podhaler Treatment based on improved efficacy and time required for administration and translate into improved respiratory status for adult patients with cystic fibrosis.

• Recruitment status: TERMINATED
• Target enrollment: 5 participants
• Primary outcome timeframe: 6 months
• Results posted on: 2024-12-06

Participant Flow

Recruitment was very slow related to cost of the medication. We also experienced difficulty getting subjects to return the questionnaire related to time involved and satisfaction with the treatment.

Subjects were asked to compare the time and satisfaction of the TOBIpodhaler treatment to their prior inhaled antibiotic administration time and satisfaction and to compare their Quality of Life (using CFR-Q) measured before and after the TOBIpodhaler.

Participant milestones

Measure	Adults- Cystic Fibrosis Adults with cystic fibrosis who have respiratory colonization with Pseudomonas Aeruginosa. The actual study will involve instructing adult patients with CF on the use of a new form of Tobramycin for inhalation (powder) and then assessing this new form of TOBI podhaler vs the old TOBI solution related to patient preference on use, time involved in taking the new medication vs the old, and impact on their pulmonary function and subsequent exacerbation rate plus quality of life.
Overall Study STARTED	5
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	5

Reasons for withdrawal

Measure	Adults- Cystic Fibrosis Adults with cystic fibrosis who have respiratory colonization with Pseudomonas Aeruginosa. The actual study will involve instructing adult patients with CF on the use of a new form of Tobramycin for inhalation (powder) and then assessing this new form of TOBI podhaler vs the old TOBI solution related to patient preference on use, time involved in taking the new medication vs the old, and impact on their pulmonary function and subsequent exacerbation rate plus quality of life.
Overall Study poor adherence of subjects to protocol and withdrawal from study.	4
Overall Study Lost to Follow-up	1

Baseline Characteristics

4 subjects did not return for evaluation 1 subject lost to follow-up All 5 subjects did not complete the study

Baseline characteristics by cohort

Measure	Subject Response to TOBIpodhaler Were Compared to Baseline n=5 Participants Individuals who were on inhaled antibiotic therapy as part of their CF management of Pseudomonas in the airway were selected if they were able to change their inhaled antibiotic to the TOBIpodhaler. These subjects would then compare their time involved in airway treatment, satisfaction with the treatment, and FEV1 to their prior-to-change value.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	27.4 years STANDARD_DEVIATION 5.95 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Region of Enrollment United States	5 Participants n=5 Participants
FEV1	0 Participants 4 subjects did not return for evaluation 1 subject lost to follow-up All 5 subjects did not complete the study

PRIMARY outcome

Timeframe: 6 months

Population: 4 of 5 patients preferred TOBIpodhaler

Number of Participants with Adherence to Tobramycin Inhaled Solution Treatment compared with TOBI Podhaler Treatment based on improved efficacy and time required for administration and translate into improved respiratory status for adult patients with cystic fibrosis.

Outcome measures

Measure	Patient Served as Own Control n=5 Participants Compared time spent and FEV1 change along with survey of preference.
Increased Adherence to the Medical Therapeutic Regimen	4 participants

SECONDARY outcome

Timeframe: 6 months

Population: Data were not collected since patients did not return for follow-up.

The subject will indicate a preference for TOBIpodhaler vs prior treatment.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: 6 months

Population: Data were not collected since patients did not return for follow-up.

spirometry was performed at baseline and at the end of the study.

Outcome measures

Outcome data not reported

Adverse Events

Tobramycin Inhaled Solution

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

TOBI Podhaler

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Robert Balk

Rush University Medical Center

Phone: 3129426744

Email: Robert_Balk@rush.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place