Trial Outcomes & Findings for Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization (NCT NCT01973998)

NCT ID: NCT01973998

Last Updated: 2020-03-12

Results Overview

A combined endpoint of time to all-cause mortality or re-hospitalization during the 180 days post-randomization was used.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 68 participants
• Primary outcome timeframe: 180 days
• Results posted on: 2020-03-12

Participant Flow

Participant milestones

Measure	Roflumilast 500 ug tablet daily for 180 days Roflumilast: PDE4 inhibitor	Placebo Placebo 1 tablet daily x 180 days Placebo: Inactive substance.
Overall Study STARTED	33	35
Overall Study COMPLETED	31	33
Overall Study NOT COMPLETED	2	2

Reasons for withdrawal

Measure	Roflumilast 500 ug tablet daily for 180 days Roflumilast: PDE4 inhibitor	Placebo Placebo 1 tablet daily x 180 days Placebo: Inactive substance.
Overall Study Death	2	2

Baseline Characteristics

Effects of Roflumilast in Hospitalized Chronic Obstructive Pulmonary Disease( COPD) on Mortality and Re-hospitalization

Baseline characteristics by cohort

Measure	Roflumilast n=31 Participants 500 ug tablet daily for 180 days Roflumilast: PDE4 inhibitor	Placebo n=33 Participants Placebo 1 tablet daily x 180 days Placebo: Inactive substance.	Total n=64 Participants Total of all reporting groups
Age, Continuous	64.2 years STANDARD_DEVIATION 7 • n=5 Participants	59.3 years STANDARD_DEVIATION 8.1 • n=7 Participants	59.6 years STANDARD_DEVIATION 7.9 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Sex: Female, Male Male	11 Participants n=5 Participants	14 Participants n=7 Participants	25 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	20 Participants n=5 Participants	21 Participants n=7 Participants	41 Participants n=5 Participants
Race (NIH/OMB) White	2 Participants n=5 Participants	3 Participants n=7 Participants	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	9 Participants n=5 Participants	8 Participants n=7 Participants	17 Participants n=5 Participants
Region of Enrollment United States	31 Participants n=5 Participants	33 Participants n=7 Participants	64 Participants n=5 Participants

PRIMARY outcome

Timeframe: 180 days

Population: Patients who completed 180 days of follow-up

A combined endpoint of time to all-cause mortality or re-hospitalization during the 180 days post-randomization was used.

Outcome measures

Measure	Roflumilast n=21 Number of hospitalizations 500 ug tablet daily for 180 days Roflumilast: PDE4 inhibitor	Placebo n=29 Number of hospitalizations Placebo 1 tablet daily x 180 days Placebo: Inactive substance.
Time to All-cause Mortality or Re-hospitalization During the 180 Days Post-randomization.	54 Days to event Interval 41.9 to 66.1	55 Days to event Interval 43.6 to 66.4

SECONDARY outcome

Timeframe: 180 days

respiratory death or respiratory re-hospitalization during the 180 days post-randomization; rate of death or readmission during the 30 days post-discharge; treatment failure (see definition below); change in health status, FEV1 (forced expiratory volume at one second, and dyspnea during the 180 days post-randomization; length of hospital stay during the index hospitalization.

Outcome measures

Measure	Roflumilast n=31 Participants 500 ug tablet daily for 180 days Roflumilast: PDE4 inhibitor	Placebo n=33 Participants Placebo 1 tablet daily x 180 days Placebo: Inactive substance.
Respiratory Death or Respiratory Re-hospitalization	21 number of events	29 number of events

OTHER_PRE_SPECIFIED outcome

Timeframe: 180 days

Reported adverse events during the course of the study. Need to withdraw study drug due to adverse events

Outcome measures

Measure	Roflumilast n=31 Participants 500 ug tablet daily for 180 days Roflumilast: PDE4 inhibitor	Placebo n=33 Participants Placebo 1 tablet daily x 180 days Placebo: Inactive substance.
Assess Tolerance of Roflumilast vs. Placebo in Hospitalized AECOPD Diarrhea	8 reported events	10 reported events
Assess Tolerance of Roflumilast vs. Placebo in Hospitalized AECOPD Weight loss	7 reported events	3 reported events
Assess Tolerance of Roflumilast vs. Placebo in Hospitalized AECOPD Nausea	11 reported events	4 reported events
Assess Tolerance of Roflumilast vs. Placebo in Hospitalized AECOPD Headache	12 reported events	15 reported events
Assess Tolerance of Roflumilast vs. Placebo in Hospitalized AECOPD Back pain	13 reported events	16 reported events
Assess Tolerance of Roflumilast vs. Placebo in Hospitalized AECOPD Insomnia	16 reported events	15 reported events
Assess Tolerance of Roflumilast vs. Placebo in Hospitalized AECOPD Decreased appetite	10 reported events	8 reported events
Assess Tolerance of Roflumilast vs. Placebo in Hospitalized AECOPD Dizziness	9 reported events	8 reported events
Assess Tolerance of Roflumilast vs. Placebo in Hospitalized AECOPD Depression	8 reported events	8 reported events

Adverse Events

Roflumilast

Serious events: 13 serious events

Other events: 16 other events

Deaths: 0 deaths

Placebo

Serious events: 16 serious events

Other events: 16 other events

Deaths: 0 deaths

Serious adverse events

Measure	Roflumilast n=31 participants at risk 500 ug tablet daily for 180 days Roflumilast: PDE4 inhibitor	Placebo n=33 participants at risk Placebo 1 tablet daily x 180 days Placebo: Inactive substance.
Respiratory, thoracic and mediastinal disorders Rehospitalization	41.9% 13/31 • Number of events 31 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint	48.5% 16/33 • Number of events 35 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint

Other adverse events

Measure	Roflumilast n=31 participants at risk 500 ug tablet daily for 180 days Roflumilast: PDE4 inhibitor	Placebo n=33 participants at risk Placebo 1 tablet daily x 180 days Placebo: Inactive substance.
Gastrointestinal disorders diarrhea	25.8% 8/31 • Number of events 8 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint	30.3% 10/33 • Number of events 10 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint
General disorders Weight loss	22.6% 7/31 • Number of events 7 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint	9.1% 3/33 • Number of events 3 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint
Gastrointestinal disorders Nausea	35.5% 11/31 • Number of events 11 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint	12.1% 4/33 • Number of events 4 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint
Nervous system disorders Headache	38.7% 12/31 • Number of events 12 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint	45.5% 15/33 • Number of events 15 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint
Musculoskeletal and connective tissue disorders Back pain	41.9% 13/31 • Number of events 13 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint	48.5% 16/33 • Number of events 16 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint
Nervous system disorders Insomnia	51.6% 16/31 • Number of events 16 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint	48.5% 16/33 • Number of events 16 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint
Gastrointestinal disorders Decreased appetite	32.3% 10/31 • Number of events 10 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint	24.2% 8/33 • Number of events 8 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint
Nervous system disorders Dizziness	29.0% 9/31 • Number of events 9 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint	24.2% 8/33 • Number of events 8 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint
Nervous system disorders Depression	25.8% 8/31 • Number of events 8 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint	24.2% 8/33 • Number of events 8 • 180 days Death was not considered an adverse event as it was part of the combined study endpoint

Additional Information

Michael R. Jacobs - Director of Research Development

Lewis Katz School of Medicine Temple University

Phone: 2157072242

Email: michael.jacobs@tuhs.temple.edu

Results disclosure agreements

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