Trial Outcomes & Findings for A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD) (NCT NCT01572948)
NCT ID: NCT01572948
Last Updated: 2015-10-19
Results Overview
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
27 participants
Primary outcome timeframe
baseline
Results posted on
2015-10-19
Participant Flow
Subjects were recruited from a single center.
Participant milestones
| Measure |
Roflumilast
group randomized to 30 day supply of white tablet 500microgram
|
Placebo
500microgram white tablet
|
|---|---|---|
|
Overall Study
STARTED
|
11
|
16
|
|
Overall Study
COMPLETED
|
10
|
15
|
|
Overall Study
NOT COMPLETED
|
1
|
1
|
Reasons for withdrawal
| Measure |
Roflumilast
group randomized to 30 day supply of white tablet 500microgram
|
Placebo
500microgram white tablet
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
1
|
0
|
|
Overall Study
unable to contact
|
0
|
1
|
Baseline Characteristics
A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)
Baseline characteristics by cohort
| Measure |
Placebo
n=16 Participants
placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
|
Roflumilast
n=11 Participants
roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
|
Total
n=27 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=5 Participants
|
62 years
n=7 Participants
|
61 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
6 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
10 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
17 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
|
4 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
8 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
16 participants
n=5 Participants
|
11 participants
n=7 Participants
|
27 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: baselineOutcome measures
| Measure |
Placebo
n=16 Participants
placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
|
Roflumilast
n=11 Participants
roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
|
|---|---|---|
|
Induced Sputum Proline-glycine-proline (PGP) Levels at Baseline
|
0.74 ng/ml
Standard Deviation 0.25
|
0.64 ng/ml
Standard Deviation 0.21
|
PRIMARY outcome
Timeframe: 1 month after baselineOutcome measures
| Measure |
Placebo
n=11 Participants
placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
|
Roflumilast
n=16 Participants
roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
|
|---|---|---|
|
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 1 Month After Randomization.
|
.33 ng/ml
Standard Deviation .12
|
.66 ng/ml
Standard Deviation .18
|
PRIMARY outcome
Timeframe: 3 months after baselineOutcome measures
| Measure |
Placebo
n=16 Participants
placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
|
Roflumilast
n=11 Participants
roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
|
|---|---|---|
|
Mean Induced Sputum Proline-glycine-proline (PGP) Levels at 3 Months After Randomization
|
0.70 ng/ml
Standard Deviation 0.18
|
0.30 ng/ml
Standard Deviation 0.11
|
SECONDARY outcome
Timeframe: 1 monthOutcome measures
| Measure |
Placebo
n=16 Participants
placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
|
Roflumilast
n=11 Participants
roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
|
|---|---|---|
|
Induced Sputum Neutrophil Count
|
83 percentage of sputum neutrophils
Standard Error .24
|
80 percentage of sputum neutrophils
Standard Error .24
|
SECONDARY outcome
Timeframe: baselineOutcome measures
| Measure |
Placebo
n=16 Participants
placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
|
Roflumilast
n=11 Participants
roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
|
|---|---|---|
|
Induced Sputum Neutrophil Count
|
89 percentage of sputum neutrophils
Standard Error .25
|
83 percentage of sputum neutrophils
Standard Error .23
|
SECONDARY outcome
Timeframe: 3 months after baselineOutcome measures
| Measure |
Placebo
n=16 Participants
placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
|
Roflumilast
n=11 Participants
roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
|
|---|---|---|
|
Induced Sputum Neutrophil Count
|
86 percentage of sputum neutrophils
Standard Error .24
|
58 percentage of sputum neutrophils
Standard Error .18
|
Adverse Events
Placebo
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Roflumilast
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Placebo
n=16 participants at risk
placebo: The placebo (Forest Laboratories, Inc) is manufactured as an odorless and otherwise equivalent tablet to the roflumilast tablet, but contains no active ingredient
|
Roflumilast
n=11 participants at risk
roflumilast: The study drug (roflumilast, Daliresp™, Forest Laboratories, Inc.) is a targeted inhibitor of phosphodiesterase 4 and is given once daily via oral route. There is proven anti-inflammatory and anti-oxidant potential in both animal and human models
|
|---|---|---|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/16 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/16 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
|
Metabolism and nutrition disorders
weight loss of 10lbs
|
0.00%
0/16 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
upper respiratory infection
|
12.5%
2/16 • Number of events 2 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
cough
|
0.00%
0/16 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
|
Reproductive system and breast disorders
pleurisy
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
pneumonia
|
6.2%
1/16 • Number of events 1 • 12 weeks
|
0.00%
0/11 • 12 weeks
|
|
Nervous system disorders
insomnia
|
0.00%
0/16 • 12 weeks
|
9.1%
1/11 • Number of events 1 • 12 weeks
|
Additional Information
J. Michael Wells, M.D.
University of Alabama at Birmingham, Division of Pulmonary, Allergy, and Critical Care Medicine
Phone: 205-934-6047
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place