Trial Outcomes & Findings for Enhancement of Corticosteroid Efficacy in COPD (NCT NCT02340520)

NCT ID: NCT02340520

Last Updated: 2018-06-19

Results Overview

Change in FEV1 L and FVC L

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 13 participants
• Primary outcome timeframe: Baseline, Week 1 and 2
• Results posted on: 2018-06-19

Participant Flow

Two of the 13 enrolled patients were found to be ineligible after being enrolled and therefore never started the study.

Participant milestones

Measure	Theophylline and Roflumilast Theophylline for one week, followed by the addition of Roflumilast for a further one week.
Overall Study STARTED	11
Overall Study COMPLETED	8
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Theophylline and Roflumilast Theophylline for one week, followed by the addition of Roflumilast for a further one week.
Overall Study Lost to Follow-up	1
Overall Study Patient did not take drug as specified	1
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Enhancement of Corticosteroid Efficacy in COPD

Baseline characteristics by cohort

Measure	Theophylline and Roflumilast n=8 Participants Theophylline for one week, followed by the addition of Roflumilast for a further one week.
Age, Continuous	67.4 years STANDARD_DEVIATION 8.2 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Race/Ethnicity, Customized White Non-Hispanic/Latino	7 Participants n=5 Participants
Race/Ethnicity, Customized African American	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline, Week 1 and 2

Change in FEV1 L and FVC L

Outcome measures

Measure	Theophylline and Roflumilast n=8 Participants Theophylline for one week, followed by the addition of Roflumilast for a further one week.
Bronchodilation baseline FEV1	1.18 liters Standard Deviation 0.51
Bronchodilation baseline FVC	2.72 liters Standard Deviation 0.78
Bronchodilation week 1 FEV1	1.22 liters Standard Deviation 0.51
Bronchodilation week 1 FVC	2.90 liters Standard Deviation 0.82
Bronchodilation post steroid week 1 FEV1	1.18 liters Standard Deviation 0.51
Bronchodilation post steroid week 1 FVC	2.72 liters Standard Deviation 0.68
Bronchodilation week 2 FEV1	1.25 liters Standard Deviation 0.58
Bronchodilation week 2 FVC	2.79 liters Standard Deviation 0.71
Bronchodilation week 2 post steroid FEV1	1.18 liters Standard Deviation 0.51
Bronchodilation week 2 post steroid FVC	2.81 liters Standard Deviation 0.61
Bronchodilation week 1, FEV1 post bronchodilator, post steroid	1.24 liters Standard Deviation 0.54
Bronchodilation week 1, FVC post bronchodilator, post steroid	2.80 liters Standard Deviation 0.65
Bronchodilation week 2, FEV1 post bronchodilator, post steroid	1.30 liters Standard Deviation 0.47
Bronchodilation week 2, FVC post bronchodilator, post steroid	2.98 liters Standard Deviation 0.67

SECONDARY outcome

Timeframe: Baseline, Week 1 and 2

circulating Histone Deacetylase2 levels measured in blood sample

Outcome measures

Measure	Theophylline and Roflumilast n=8 Participants Theophylline for one week, followed by the addition of Roflumilast for a further one week.
Change in HDAC2 Levels baseline	2.96 µM/µg Standard Error 0.73
Change in HDAC2 Levels week 1	2.58 µM/µg Standard Error 0.91
Change in HDAC2 Levels week 2	2.81 µM/µg Standard Error 0.40

Adverse Events

Theophylline and Roflumilast

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

Nausherwan Burki, MD

UConn Health

Email: nburki@uchc.edu

Results disclosure agreements

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