CLINICAL TRIALS PROFILE FOR DALIRESP

All Clinical Trials for daliresp

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01433666 ↗	Roflumilast and Cognition	Completed	ZonMw: The Netherlands Organisation for Health Research and Development	Phase 2	2011-09-01	The aim of the current project is to validate PDE4 inhibitors as a target for cognition enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will demonstrate whether memory, but also attention, information processing or executive function improves with the PDE4 inhibitor roflumilast in healthy humans.
NCT01433666 ↗	Roflumilast and Cognition	Completed	Maastricht University Medical Center	Phase 2	2011-09-01	The aim of the current project is to validate PDE4 inhibitors as a target for cognition enhancers (proof-of-concept) using a translational behaviour-EEG approach. The project will demonstrate whether memory, but also attention, information processing or executive function improves with the PDE4 inhibitor roflumilast in healthy humans.
NCT01443845 ↗	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	Completed	AstraZeneca	Phase 4	2011-09-30	To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
NCT01443845 ↗	Roflumilast in Chronic Obstructive Pulmonary Disease (COPD) Patients Treated With Fixed Dose Combinations of Long-acting β2-agonist (LABA) and Inhaled Corticosteroid (ICS)	Completed	Forest Laboratories	Phase 4	2011-09-30	To demonstrate the additional benefit of roflumilast when added on to fixed-dose combination (FDC) LABA/ICS in the reduction of exacerbations in subjects with severe to very severe COPD.
NCT01572948 ↗	A Placebo-controlled Trial of Daliresp on Chronic Obstructive Pulmonary Disease (COPD)	Completed	University of Alabama at Birmingham	N/A	2012-06-01	The purpose of the study is to propose that roflumilast is associated with meaningful reductions in biomarkers of pulmonary inflammation and sputum neutrophilia, including confirmation of previously described results, and correlate these findings with improvement in pulmonary function, sputum scores, and quality of life in stable moderate to severe COPD. The investigators aim to demonstrate this regardless of concomitant medication use, including inhaled corticosteroids. Additionally, the investigators hope to provide a mechanistic pathway by which these effects occur.
NCT01745848 ↗	Roflumilast on Markers of Bone Metabolism and Endothelial Function in COPD	Completed	University of Pittsburgh	Phase 4	2013-02-01	Our primary hypothesis is that Roflumilast (500 μcg, once daily) will significantly decrease surrogate markers of bone metabolism and early cardiovascular disease in individuals with moderate to severe airflow obstruction and a chronic bronchitis phenotype.

Clinical Trial Conditions for daliresp

Condition Name

Condition Name for daliresp
Intervention	Trials
COPD	5
Asthma	3
Chronic Bronchitis	2
Lymphoma, B-Cell	2

Condition MeSH

Condition MeSH for daliresp
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	6
Lung Diseases, Obstructive	5
Lung Diseases	5
Bronchitis, Chronic	3

Clinical Trial Locations for daliresp

Trials by Country

Trials by Country for daliresp
Location	Trials
United States	79
Argentina	5
Canada	5
Mexico	3
Serbia	2

Trials by US State

Trials by US State for daliresp
Location	Trials
Texas	5
California	4
Alabama	4
Pennsylvania	4
Maryland	3

Clinical Trial Progress for daliresp

Clinical Trial Phase

Clinical Trial Phase for daliresp
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	3
Phase 2	3

Clinical Trial Status

Clinical Trial Status for daliresp
Clinical Trial Phase	Trials
Completed	11
Recruiting	3
Active, not recruiting	1

Clinical Trial Sponsors for daliresp

Sponsor Name

Sponsor Name for daliresp
Sponsor	Trials
Forest Laboratories	3
Johns Hopkins University	3
University of Pittsburgh	2

Sponsor Type

Sponsor Type for daliresp
Sponsor	Trials
Other	23
Industry	7
NIH	2

Daliresp Market Analysis and Financial Projection

DALIRESP: Clinical Trials, Market Analysis, and Projections

Introduction to DALIRESP

DALIRESP, also known as roflumilast, is a long-acting selective phosphodiesterase 4 (PDE4) inhibitor. It is approved for the maintenance treatment of severe chronic obstructive pulmonary disease (COPD) associated with chronic bronchitis in adult patients with a history of frequent exacerbations, used as an add-on to bronchodilator treatment[3].

Clinical Trials Overview

Current and Recent Trials

DALIRESP has been involved in several clinical trials to evaluate its efficacy and safety. Here are some key points from recent and ongoing trials:

• Pivotal Studies: Two 1-year, double-blind, placebo-controlled studies involving 3091 patients with severe COPD associated with chronic bronchitis and a history of exacerbations compared DALIRESP 500 mcg with placebo. These studies showed that patients treated with DALIRESP had a lower rate of moderate or severe COPD exacerbations compared to those on placebo[1].

• PILLAR Study: A 52-week, placebo- and active-controlled study is evaluating the efficacy and safety of two doses of CHF6001 (Tanimilast) as an add-on to maintenance triple therapy in subjects with COPD and chronic bronchitis. DALIRESP 500µg is used as an active control in this study[4].

• Phase 3 Trials: Various Phase 3 trials are ongoing, sponsored by entities such as Chiesi Farmaceutici S.p.A., Johns Hopkins University, and the Patient-Centered Outcomes Research Institute. These trials continue to assess the efficacy and safety of DALIRESP in different patient populations[5].

Efficacy and Safety

Reduction in COPD Exacerbations

The pivotal studies demonstrated that patients treated with DALIRESP had a 20% lower rate of moderate or severe COPD exacerbations compared to those treated with placebo. Moderate exacerbations were defined as those requiring treatment with systemic corticosteroids, and severe exacerbations were those resulting in hospitalization or death[1].

Lung Function

While DALIRESP is not a bronchodilator and should not be used for the relief of acute bronchospasm, it showed a statistically significant increase in pre-bronchodilator FEV1 (forced expiratory volume in one second) compared to placebo when used in conjunction with bronchodilators. However, this increase was not clinically meaningful[1].

Adverse Reactions

In the clinical trials, 5.9% of patients treated with DALIRESP reported psychiatric adverse reactions, compared to 3.3% of those treated with placebo. This highlights the need for careful patient monitoring[1].

Market Analysis

Current Market Position

DALIRESP is indicated for the maintenance treatment of severe COPD associated with chronic bronchitis and a history of exacerbations. It is used as an add-on to bronchodilator treatment, which positions it as a complementary therapy rather than a standalone treatment[3].

Market Projections

The COPD treatment market is expected to grow, driven by the increasing prevalence of the disease and the need for effective management strategies. While specific projections for DALIRESP are not as detailed as those for other COPD treatments, its role as an add-on therapy suggests it will continue to be a valuable option for patients with severe COPD.

Competitive Landscape

The COPD market is competitive, with various bronchodilators and other add-on therapies available. However, DALIRESP's unique mechanism of action as a PDE4 inhibitor sets it apart. The market dynamics are influenced by the availability of other treatments, but DALIRESP's efficacy in reducing exacerbations makes it a significant player[3].

Financial Projections

Revenue and Growth

While specific financial projections for DALIRESP are not widely available, the overall COPD market is expected to grow. The use of DALIRESP as an add-on therapy suggests that its revenue will be influenced by the broader trends in COPD treatment, including the increasing use of combination therapies and the need for effective exacerbation prevention[5].

Unmet Needs and Future Directions

Expanding Indications

DALIRESP has been under development for various other indications, including cognitive impairment associated with schizophrenia, asthma, and nonalcoholic steatohepatitis, among others. However, its primary approved use remains in the treatment of COPD[3].

Ongoing Research

Ongoing clinical trials, such as the PILLAR study, continue to evaluate the efficacy and safety of DALIRESP in different contexts. These studies aim to further establish its role in COPD management and potentially expand its indications.

Key Takeaways

• Efficacy in COPD: DALIRESP significantly reduces the risk of moderate or severe COPD exacerbations in patients with severe COPD associated with chronic bronchitis.
• Add-on Therapy: It is used as an add-on to bronchodilator treatment, not as a standalone therapy.
• Safety Profile: Patients should be monitored for psychiatric adverse reactions.
• Market Position: DALIRESP is a valuable option in the COPD treatment market due to its unique mechanism of action.
• Future Directions: Ongoing trials may expand its indications and further solidify its role in COPD management.

FAQs

What is DALIRESP used for?

DALIRESP is used to reduce the risk of COPD exacerbations in patients with severe COPD associated with chronic bronchitis and a history of exacerbations.

Is DALIRESP a bronchodilator?

No, DALIRESP is not a bronchodilator and should not be used for the relief of acute bronchospasm.

What are the common adverse reactions associated with DALIRESP?

Psychiatric adverse reactions are more common in patients treated with DALIRESP compared to those treated with placebo.

Can DALIRESP be used as a standalone treatment?

No, DALIRESP is indicated for use as an add-on to bronchodilator treatment.

What are the ongoing clinical trials evaluating DALIRESP for?

Ongoing trials are evaluating the efficacy and safety of DALIRESP in various contexts, including its use as an add-on to maintenance triple therapy in COPD patients.

Sources

1. DALIRESP Efficacy: For HCPs - DALIRESP®(roflumilast) Efficacy.
2. NSCLC Market Analysis: NSCLC MARKET - Global Drug Forecast & Market Analysis to 2025.
3. DALIRESP Drug Analysis: Net Present Value Model: Daliresp - GlobalData.
4. PILLAR Study: Controlled (Roflumilast, Daliresp® 500µg) Study to Evaluate the Efficacy and the Safety of Two Doses of CHF6001 (Tanimilast) as add-on to Maintenance Triple Therapy.
5. DALIRESP Drug Patent Profile: DALIRESP Drug Patent Profile - DrugPatentWatch.