DFDA

Roflumilast (PDE4 Inhibitor)

Treatment for Copd

Typical Dosage: Roflumilast 500 mcg once daily

Effectiveness
60%
Safety Score
55%
Clinical Trials
4
Participants
15K

Comparative Safety Scale(Higher is safer)

Cyanide☠️
Meth💀
Cigarettes🚬
Chemo☢️
Alcohol🍺
Morphine💊
Antibiotics💉
Tylenol💊
Exercise🏃
Water💧
55
DangerousModerateSafe
Treatment Details
Dosage Range
Roflumilast 500 mcg once daily
Time to Effect
Weeks-months (exacerbation reduction)
Treatment Duration
Lifetime
Evidence Quality
HIGH
Number Needed to Treat (NNT)
10(Treat 10 patients to see 1 additional successful outcome)
Number Needed to Harm (NNH)
7(Treat 7 patients to see 1 additional serious adverse event)
Confidence Score
85%confidence in effectiveness data
Health Economics
Annual Cost of Care
Drug Cost:$5,400
Monitoring:$800
Side Effect Mgmt:$100
Total Annual:$6,300
Cost-Effectiveness Analysis
Cost-Effectiveness Rating
POOR
ICER
$200,000/QALY
QALYs Gained
0.02
Outcome-Based Costs
Cost per Responder
$12,600
Comparison vs Usual Care
Cost Difference
+$6,300/year
More expensive
QALY Difference
+0.02 QALYs
Better outcomes
Dominance
No dominance
Roflumilast (PDE4 Inhibitor) Outcomes

for Copd

Efficacy Outcomes
Overall Effectiveness
+60%
Response Rate
+50%
Common Side Effects
Diarrhea
+15%
Nausea
+8%
Headache
+7%
Weight loss
+5%
Insomnia
+4%

Sources:

nih.gov
dovepress.com
researchgate.net

WARNING: LIMITED TRIALS AVAILABLE

You can search for trials, but you probably can't join any because the 1% Treaty hasn't passed yet. Most trials are severely limited by lack of funding and bureaucratic barriers. Help change this!

Active Clinical Trials
No active trials currently recruiting for this treatment

No active trials found in ClinicalTrials.gov

Completed Clinical Trials
3 completed trials for Roflumilast (PDE4 Inhibitor) in Copd

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

NCT01973998COMPLETEDPHASE3
View Study
68 participants
INTERVENTIONAL
Philadelphia, United States
Started: Nov 1, 2013

Efficacy and Safety of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-06)

NCT00242294COMPLETEDPHASE2, PHASE3
View Study
570 participants
INTERVENTIONAL
Osaka, Japan
Started: Nov 1, 2004

Long-term Study of Safety and Efficacy of Roflumilast in Japanese Patients Older Than 40 Years With Chronic Obstructive Pulmonary Disease (APTA-2217-08)

NCT00246935COMPLETEDPHASE3
View Study
150 participants
INTERVENTIONAL
Osaka, Japan
Started: May 1, 2005