Roflumilast

Chronic Obstructive Pulmonary Disease

Treatment

1 FDA approval

20 Active Studies for Roflumilast

Treatment for

Chronic Obstructive Pulmonary Disease

What is Roflumilast

RoflumilastThe Generic name of this drug

Treatment SummaryRoflumilast is a medication used to treat exacerbations of chronic obstructive pulmonary disease (COPD). It works by blocking an enzyme called phosphodiesterase-4 (PDE-4) in the lungs. However, this drug may increase the risk of mental health side effects, including suicidal thoughts and behavior.

Dalirespis the brand name

image of different drug pills on a surface

Roflumilast Overview & Background

Brand Name

Generic Name

First FDA Approval

How many FDA approvals?

Daliresp

Roflumilast

2011

Approved as Treatment by the FDA

Roflumilast, otherwise called Daliresp, is approved by the FDA for 1 uses including Chronic Obstructive Pulmonary Disease .

Chronic Obstructive Pulmonary Disease

Helps manage Chronic Obstructive Pulmonary Disease (COPD)

Effectiveness

How Roflumilast Affects PatientsRoflumilast and its active metabolite, roflumilast N-oxide, help increase a type of cellular energy (cyclic adenosine-3′, 5′-monophosphate) in cells affected by the drug. They are very specific for this purpose and don't affect other energy producing molecules.

How Roflumilast works in the bodyRoflumilast is a drug that works by blocking an enzyme in the body called phosphodiesterase-4. This increases levels of a molecule called cyclic AMP, which helps reduce inflammation and modulate the immune system in the lungs.

When to interrupt dosage

The dosage of Roflumilast is contingent upon the diagnosed ailment. The measure likewise varies as indicated by the technique of delivery noted in the table below.

Condition

Dosage

Administration

Chronic Obstructive Pulmonary Disease

, 0.5 mg, 0.25 mg

Oral, Tablet, , Tablet - Oral, Tablet, film coated, Tablet, film coated - Oral

Warnings

Roflumilast Contraindications

Condition

Risk Level

Notes

Liver

Do Not Combine

There are 20 known major drug interactions with Roflumilast.

Common Roflumilast Drug Interactions

Drug Name

Risk Level

Description

2-Methoxyethanol

Minor

Roflumilast may increase the immunosuppressive activities of 2-Methoxyethanol.

9-(N-methyl-L-isoleucine)-cyclosporin A

Minor

Roflumilast may increase the immunosuppressive activities of 9-(N-methyl-L-isoleucine)-cyclosporin A.

Abatacept

Minor

Roflumilast may increase the immunosuppressive activities of Abatacept.

Abetimus

Minor

Roflumilast may increase the immunosuppressive activities of Abetimus.

Aclidinium

Minor

Roflumilast may decrease the excretion rate of Aclidinium which could result in a higher serum level.

Roflumilast Toxicity & Overdose RiskThere is no information available on overdosing on roflumilast when taken by mouth. In some cases, patients have experienced headaches, digestive issues, dizziness, racing heart, feeling faint, and low blood pressure at doses of up to 5000 mcg. If an overdose occurs, get medical help right away. It is not likely that hemodialysis will be helpful due to the drug's high protein binding.

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Roflumilast Novel Uses: Which Conditions Have a Clinical Trial Featuring Roflumilast?

98 active studies are currently assessing the possible therapeutic efficacy of Roflumilast in the management of Chronic Obstructive Pulmonary Disease (COPD).

Condition

Clinical Trials

Trial Phases

Chronic Obstructive Pulmonary Disease

77 Actively Recruiting

Phase 3, Phase 1, Phase 2, Not Applicable, Early Phase 1, Phase 4

Roflumilast Reviews: What are patients saying about Roflumilast?

5Patient Review

2/11/2012

Roflumilast for COPD with Chronic Bronchitis

I've had some trouble sleeping, but I've lost a lot of weight, which is great.

2.3Patient Review

4/23/2014

Roflumilast for COPD with Chronic Bronchitis

I haven't seen any difference since starting this pill. Not sure if it's working or not.

1Patient Review

3/20/2012

Roflumilast for COPD with Chronic Bronchitis

I felt awful after taking this medication. I had every symptom of the flu, but much worse. I was completely housebound for two weeks.

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Patient Q&A Section about roflumilast

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What type of drug is roflumilast?

"Roflumilast belongs to a class of drugs known as phosphodiesterase inhibitors. These drugs work by decreasing inflammation in the lungs."

Answered by AI

Is roflumilast a steroid?

"Roflumilast is a good PDE4 inhibitor to look into as an option to help decreased the amount of steroids patients with COVID-19 need."

Answered by AI

What is the indication of roflumilast?

"This medication is indicated to help reduce exacerbations (worsening of symptoms) in people who have severe COPD associated with chronic bronchitis, and who have a history of exacerbations. It is not a bronchodilator and is not indicated for treating acute bronchospasm."

Answered by AI

How does roflumilast help with COPD?

"Roflumilast is an enzyme inhibitor that specifically targets the inflammation associated with COPD. In addition to reducing inflammatory mediators, it also prevents cell surface Markers from being expressed and halts apoptosis."

Answered by AI

What is roflumilast used for?

"Roflumilast is a medication used to reduce the number of episodes or worsening of symptoms in people with severe chronic obstructive pulmonary disease (COPD). Roflumilast is a class of phosphodiesterase inhibitors."

Answered by AI

What are some of the side effects of roflumilast?

"The following side effects may occur while taking this medication: diarrhea, weight loss, stomach/abdominal pain, nausea, loss of appetite, headache, or dizziness. If you experience any of these side effects, inform your doctor or pharmacist immediately. Keep track of your weight while taking this medication, and let your doctor know if you experience any extreme or unusual weight loss."

Answered by AI

Clinical Trials for Roflumilast

Image of Stanford University in Stanford, United States.

MoblO2 for Chronic Lung Diseases

18+

All Sexes

Stanford, CA

Many patients with chronic lung disease (e.g., chronic obstructive pulmonary disease (COPD) or interstitial lung disease (ILD)) require supplemental oxygen (O2) at some point during their disease course. Practitioners prescribe O2 to patients with chronic lung disease in hopes of the following: 1) that it will limit desaturation events and combat breathlessness, thus preventing the frustratingly slow pace and numerous rest breaks patients are forced to adopt while doing even simple tasks; 2) that it will allow patients to be more active physically (perhaps increase their ability to exercise) and socially (perhaps leave the home more often); 3) that it will stave off putative complications of hypoxemia (e.g., cognitive dysfunction, pulmonary hypertension) and 4) that it will improve health-related quality of life (HRQL). However, despite the rationale for O2, and prescribers' good intentions, patients generally view O2 with frustration and fear - it threatens their HRQL, which is already impaired by having a condition that imposes itself on every aspect of their lives. Nasal cannulas and delivery devices call unwanted attention to patients when they are out in public. O2 users feel stigmatized and are often viewed as "smokers who get what they deserve, even if they never smoked a day in their lives" - or as disabled, sick or even infectious. O2 steals patients' independence, forcing them to plan their lives around it. The anxiety that patients and their caregivers experience around running out of oxygen, or not getting enough, immobilizes them and restricts participation in activities outside of the home. O2 disrupts the home environment, adding stress, and creating a burden for patients' caregiver-loved-ones who are often saddled with the responsibility of ensuring adequate equipment and supply of O2, and O2 is a constant reminder to patients they are living with a condition that could shorten their lives. O2 delivery equipment is typically heavy, unwieldy and intimidating. Different recommendations (e.g., insurance companies use 88% as a cut-off for SpO2, while many practitioners focus on 90%) make it confusing for patients, which almost certainly affects adherence. O2-requiringpatients are starving for things that can make their lives easier. An auto-adjusting O2 delivery device - one that automatically delivers the correct amount of O2 to maintain blood oxygen at desired, pre-set levels - would alleviate the need for patients to constantly (incessantly for many) monitor their peripheral oxygen saturation (SpO2) and adjust O2flow to meet the demands as exertion levels vary . The MoblO2 device is a battery-operated, light-weight, closed-loop O2 delivery device that houses a regulator (which attaches to compressed gas O2 tanks) and adjusts O2 flow to meet a pre-set blood oxygen level. A pulse oximeter is worn on the ear and transmits via Bluetooth to the device, which adjusts an internal valve to control flow on a second-to-second basis. The user sets the dial to the highest flow of O2 needed to meet the demands of activities they might perform (up to 15 liters per minute), and the device adjusts flow, up to the pre-set level to maintain SpO2 at a preset level (e.g., \> 90%). To conserve O2 supply in the tank - and to avoid over-oxygenation (which could be problematic for a small percentage of patients with the most severe COPD) - the MoblO2 begins to limit O2 flow at a SpO2 of 93%. The device can be manually over-ridden by the user, and should the battery run out - or the device fail for some unforeseen reason - the default position is valve open, so the users receive whatever flow of oxygen has been set on the dial. Given the substantial burdens of O2 on patients and their families, the hassles patients describe with having to monitor their SpO2 and repeatedly adjust the flow of O2 to meet their needs, patients and experts around the world have called for improvements in O2 delivery equipment. The MoblO2 is just such a remarkable improvement and a giant step forward in helping to ease the burdens of O2 on patients who require it. The purpose of this study is to investigate the effects of the MoblO2 O2 delivery device on a range of outcomes, including physical activity, amount (liters) O2 use; maintenance of adequate SpO2 levels; patient reported outcomes including symptoms, HRQL and satisfaction with the MoblO2 O2 device.

Waitlist Available

Has No Placebo

Stanford UniversityJeff Swigris, DO, MSMinnesota Health Solutions

Have you considered Roflumilast clinical trials? We made a collection of clinical trials featuring Roflumilast, we think they might fit your search criteria.

Have you considered Roflumilast clinical trials? We made a collection of clinical trials featuring Roflumilast, we think they might fit your search criteria.