Trial Outcomes & Findings for Treatment of Pneumocystis in COPD (the TOPIC Study) (NCT NCT05418777)

NCT ID: NCT05418777

Last Updated: 2023-11-29

Results Overview

Change in total score on the COPD Assessment Test (CAT); the test has a score of 0 (minimum) - 40 (maximum); a lower score means a better outcomes and a higher score means a worse outcome. Negative numbers indicate improvement of condition. Positive numbers indicate worsening of condition.

• Recruitment status: TERMINATED
• Study phase: PHASE1/PHASE2
• Target enrollment: 1 participants
• Primary outcome timeframe: Baseline to 3 months
• Results posted on: 2023-11-29

Participant Flow

Participant milestones

Measure	TMP-SMX Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Overall Study STARTED	1	0
Overall Study COMPLETED	1	0
Overall Study NOT COMPLETED	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Race and Ethnicity were not collected from any participant.

Baseline characteristics by cohort

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days	Total n=1 Participants Total of all reporting groups
Age, Continuous	64 years n=1 Participants	—	64 years n=1 Participants
Sex: Female, Male Female	1 Participants n=1 Participants	—	1 Participants n=1 Participants
Sex: Female, Male Male	0 Participants n=1 Participants	—	0 Participants n=1 Participants
Race and Ethnicity Not Collected	—	—	0 Participants Race and Ethnicity were not collected from any participant.
Region of Enrollment United States	1 participants n=1 Participants	—	1 participants n=1 Participants

PRIMARY outcome

Timeframe: Baseline to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Change in total score on the COPD Assessment Test (CAT); the test has a score of 0 (minimum) - 40 (maximum); a lower score means a better outcomes and a higher score means a worse outcome. Negative numbers indicate improvement of condition. Positive numbers indicate worsening of condition.

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Change in the COPD Assessment Test Baseline to Day 10	-10 number on a scale Standard Deviation 0	—
Change in the COPD Assessment Test Baseline to Day 30	-6 number on a scale Standard Deviation 0	—
Change in the COPD Assessment Test Baseline to Day 90	-2 number on a scale Standard Deviation 0	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Length of stay in the hospital for index exacerbation measured in days

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Length of Stay for Current AECOPD	5 numbers of days Standard Deviation 0	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Time to return to baseline oxygenation for the index exacerbation measured in days

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Time to Return to Baseline Oxygen for the Current AECOPD	0 days Standard Deviation 0	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Time between exacerbation of COPD measured in days

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Interval Between Exacerbations of COPD Baseline to 1st exacerbation	33 days Standard Deviation 0	—
Interval Between Exacerbations of COPD 1st exacerbation to 2nd exacerbation	7 days Standard Deviation 0	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Time before next admission to the hospital measured in days

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Interval Between Hospital Admissions	40 days Standard Deviation 0	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Total number of urgent care visits following the index exacerbation

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Number of Urgent Care Visits (Total)	0 number of visits Standard Deviation 0	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Number of urgent care visits related to COPD following the index exacerbation

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Number of Urgent Care Visits (Related to COPD)	0 number of visits Standard Deviation 0	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Total number of hospital admissions following the index exacerbation

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Number of Hospital Admissions (Total)	1 number of visits Standard Deviation 0	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Number of hospital admissions related to COPD following the index exacerbation

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Number of Hospital Admissions (Related to COPD)	1 number of visits Standard Deviation 0	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Number of patients that show clearance of PJ

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Clearance of PJ From Treated Patients	1 Participants	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Number of patients who cleared PJ and did not show re-colonization with pathogen

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Durability of Clearance of PJ From Treated Patients	1 Participants	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Number of medications used to treat COPD

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Need for Medications to Treat COPD	5 number of medications Standard Deviation 0	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Number of participants who required mechanical ventilation

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Need for Mechanical Ventilation	0 Participants	—

SECONDARY outcome

Timeframe: up to 3 months

Population: No participants were enrolled and randomized to the placebo arm

Number of participants who died

Outcome measures

Measure	TMP-SMX n=1 Participants Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Mortality	0 Participants	—

Adverse Events

TMP-SMX

Serious events: 0 serious events

Other events: 1 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	TMP-SMX n=1 participants at risk Suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days Trimethoprim Sulfamethoxazole: Receipt of suspension with the equivalent of one DS TMP-SMX by mouth every 12 hours for 10 days	Placebo Suspension with placebo by mouth every 12 hours for 10 days Placebo: Receipt of suspension with placebo by mouth every 12 hours for 10 days
Infections and infestations Candida Vaginitis	100.0% 1/1 • Number of events 1 • 3 months No participants were enrolled and randomized to the placebo arm	— 0/0 • 3 months No participants were enrolled and randomized to the placebo arm

Additional Information

Maureen Cooney, RN Clinical Research Manager

William Beaumont Hospitals

Phone: 2485510099

Email: maureen.cooney@corewellhealth.org

Results disclosure agreements

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