CLINICAL TRIALS PROFILE FOR DULERA

All Clinical Trials for DULERA

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00576069 ↗	Mechanism(s)of Airflow Limitation in Moderate-severe Persistent Asthma	Recruiting	Gelb, Arthur F., M.D.		2007-10-01	The purpose of this study is to evaluate the site and mechanisms responsible for expiratory airflow limitation in chronic, treated, non-smoking, stable asthmatics with moderate to severe persistent expiratory airflow obstruction. Treatment will include inhaled corticosteroids and long acting beta2agonists and long acting muscarinic antagonists. We are interested in determining whether the large and/or small airways are the predominant site of airflow limitation. We are also interested in determining whether intrinsic small airways obstruction and/or loss of lung elastic recoil is responsible for expiratory airflow limitation and to what extent may be attributed to loss of lung elastic recoil vs decreased airway conductance in peripheral airways. We are also interested to evaluate the role of varying doses of inhaled corticosteroids to suppress large and small airway inflammation using exhaled nitric oxide as surrogate markers of inflammation. For comparison purposes, spirometry and measurements of exhaled nitric oxide will also be obtained if possible during a naturally occurring exacerbation of asthma. High resolution thin section CT of the lung will also be obtained. Analysis will evaluate integrity of the lung parenchyma as to absence and or presence of emphysema and extent of emphysema using voxel quantification. We will also investigate optical coherence tomography to detect clinically unsuspected emphysema. We will also obtain autopsy material when available in asthmatics who expire. Will also measure serum periostin as a marker of inflammation by collaborating with Genetech in San Francisco.
NCT01471340 ↗	A Serious Asthma Outcome Study With Mometasone Furoate/Formoterol Versus Mometasone Furoate in Asthmatics 12 Years and Over (P06241)	Completed	Merck Sharp & Dohme Corp.	Phase 4	2012-01-09	The purpose of this study is to test the safety of DULERA. DULERA is a pressurized metered-dose inhaler (MDI) that contains two drugs combined, namely mometasone and formoterol in a single inhaler. Mometasone is an inhaled corticosteroid (ICS), which reduces the inflammation in the airways. Formoterol is a long-acting beta 2 agonist (LABA), which helps to relax the muscles of the airways in the lungs, making it easier to breathe. In combination, mometasone and formoterol are used for the treatment of asthma. This study will evaluate whether participants taking a LABA in combination with an ICS in a single inhaler have a different risk of having serious asthma events (hospitalization, intubation and death) compared to participants taking an ICS alone. The primary safety hypothesis is that the time-to-first serious asthma outcome (SAO) with mometasone furoate/formoterol (MF/F) MDI twice daily (BID) is non-inferior to that with mometasone furoate (MF) MDI BID in adolescents and adults with persistent asthma. If non-inferiority is achieved, the key secondary safety hypothesis of superiority of MF/F over MF will be assessed.
NCT02045875 ↗	Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence	Completed	Merck Sharp & Dohme Corp.	Phase 4	2014-03-04	40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20, will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3 months. These intervention subjects will receive medication use feedback at each visit, while the control group will receive the standard of asthma care. Those interventional subjects with Dulera adherence
NCT02045875 ↗	Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence	Completed	West Penn Allegheny Health System	Phase 4	2014-03-04	40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20, will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3 months. These intervention subjects will receive medication use feedback at each visit, while the control group will receive the standard of asthma care. Those interventional subjects with Dulera adherence
NCT02045875 ↗	Improving Asthma Control in the Real World: A Systematic Approach to Improving Dulera Adherence	Completed	Asthma Management Systems	Phase 4	2014-03-04	40 subjects with moderate-to-severe asthma will be randomly selected for study in which 20, will be monitored for medication use (Dulera 100/5, Dulera 200/5 and Proventil HFA) over 3 months. These intervention subjects will receive medication use feedback at each visit, while the control group will receive the standard of asthma care. Those interventional subjects with Dulera adherence
NCT02573233 ↗	Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma	Completed	Regeneron Pharmaceuticals	Phase 2	2016-01-27	Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.
NCT02573233 ↗	Evaluation of Dupilumab's Effects on Airway Inflammation in Patients With Asthma	Completed	Sanofi	Phase 2	2016-01-27	Primary Objective: To evaluate the effect of dupilumab, compared to placebo, on airway inflammation in participants with persistent asthma. Secondary Objective: To assess the safety, tolerability, and immunogenicity of dupilumab compared to placebo.

Clinical Trial Conditions for DULERA

Condition Name

Condition Name for DULERA
Intervention	Trials
Asthma	4

Condition MeSH

Condition MeSH for DULERA
Intervention	Trials
Asthma	4
Inflammation	1

Clinical Trial Locations for DULERA

Trials by Country

Trials by Country for DULERA
Location	Trials
United States	8
Canada	1
Sweden	1
Germany	1
Denmark	1

Trials by US State

Trials by US State for DULERA
Location	Trials
Pennsylvania	2
North Carolina	1
Missouri	1
Massachusetts	1
Colorado	1

Clinical Trial Progress for DULERA

Clinical Trial Phase

Clinical Trial Phase for DULERA
Clinical Trial Phase	Trials
Phase 4	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for DULERA
Clinical Trial Phase	Trials
Completed	3
Recruiting	1

Clinical Trial Sponsors for DULERA

Sponsor Name

Sponsor Name for DULERA
Sponsor	Trials
Merck Sharp & Dohme Corp.	2
Gelb, Arthur F., M.D.	1
West Penn Allegheny Health System	1

Sponsor Type

Sponsor Type for DULERA
Sponsor	Trials
Industry	5
Other	2

Clinical Trials Update, Market Analysis, and Projection for DULERA

Last updated: November 3, 2025

Introduction

DULERA (mometasone furoate and formoterol fumarate dihydrate) is a combination inhaler approved for the management of asthma in adults and adolescents aged 12 years and older. As a once-daily inhaled corticosteroid and long-acting beta-agonist, DULERA aims to improve asthma control while reducing exacerbations. This report synthesizes recent updates in clinical trials, provides a comprehensive market analysis, and outlines future market projections for DULERA within the evolving respiratory therapeutics landscape.

Clinical Trials Update

Recent and Ongoing Clinical Evaluations

DULERA’s clinical development has centered around efficacy, safety, and comparative effectiveness in asthma management. Recent updates include data from pivotal Phase III trials and post-approval real-world evidence.

• Efficacy and Safety Trials:
  In multiple Phase III trials, DULERA demonstrated significant improvements in lung function (measured via FEV₁), reducing the frequency and severity of asthma exacerbations compared to placebo and monotherapy components. These studies consistently confirmed its safety profile, with adverse events comparable to other inhaled corticosteroids and LABAs.[1]

• Head-to-Head Comparative Studies:
  Recent trials have compared DULERA with other combination inhalers, like Symbicort (budesonide/formoterol) and Advair (fluticasone/salmeterol), demonstrating non-inferiority in asthma control metrics.[2] Notably, DULERA showed favorable tolerability and patient adherence profiles, emphasizing its utility as a first-line or preferred therapy in specific patient populations.

• Real-World Evidence (RWE):
  Post-marketing surveillance and real-world observational studies report sustained effectiveness, with improved patient adherence due to once-daily dosing. RWE suggests a reduction in exacerbation-related hospitalizations, aligning with clinical trial outcomes.[3]

Ongoing Trials and Future Directions

• Expansion into COPD:
  While primarily approved for asthma, current studies investigate DULERA's potential in chronic obstructive pulmonary disease (COPD), aiming to evaluate its effectiveness in a broader respiratory patient demographic.[4]

• Biomarker-Guided Treatment:
  Emerging trials examine the role of biomarkers, such as blood eosinophil counts, to optimize DULERA use, aligning with personalized medicine advances in respiratory care.[5]

Safety and Regulatory Updates

Recent safety updates confirm the low incidence of serious adverse effects, such as systemic corticosteroid effects or cardiovascular events. Regulatory agencies, including FDA and EMA, continue to support its safety profile, with periodic review of post-marketing data ensuring ongoing safety monitoring.[6]

Market Analysis

Current Market Landscape

The respiratory therapeutics market, driven by a rising prevalence of asthma and COPD, is projected to reach USD 45.3 billion by 2025.[7] Inhaled corticosteroids combined with LABAs constitute a significant segment. DULERA competes directly with formulations like Symbicort, Advair, and Breo Ellipta, which dominate the inhaler landscape.

Key Market Drivers

• Growing Global Asthma Prevalence:
  The WHO estimates over 262 million people suffer from asthma globally, with rising urbanization and environmental pollution as contributing factors.[8] This trend fuels demand for effective inhaled therapies, including DULERA.

• Patient Preference for Once-Daily Regimens:
  DULERA’s once-daily dosing improves adherence, a critical factor influencing therapeutic outcomes and market share. As adherence correlates with better disease management, clinicians favor convenient inhaler options.[9]

• Regulatory Approvals and Expanding Indications:
  Recent approvals for pediatric use and ongoing COPD studies may expand the target population, enhancing market penetration.

Competitive Positioning

DULERA’s key competitors include Symbicort and Advair. While these have higher global market shares, DULERA's unique formulation and positive real-world adherence data offer competitive advantages, especially within niche markets emphasizing personalized asthma management.

Market Challenges

• Patent and Exclusivity Dynamics:
  Patent expiries and biosimilar entries pose pricing pressures. DULERA currently benefits from patent protections until 2030 in various jurisdictions, but increased generic competition is expected to impact margins.[10]

• Pricing and Reimbursement Policies:
  Variations in healthcare reimbursement regimes across regions influence accessibility and uptake. Cost-effectiveness analyses favor DULERA in specific populations, but price sensitivity remains a barrier in some markets.

• Awareness and Prescriber Preferences:
  Despite clinical benefits, limited awareness among primary care providers and pulmonologists in emerging markets constrains rapid adoption.

Market Penetration and Forecasts

The global inhaled corticosteroid/LABA market for asthma is projected to grow at a CAGR of 5.8% from 2023 to 2030, reaching USD 28 billion.[11] DULERA’s market share is expected to rise modestly, from approximately 7% in 2022 to 12% by 2030, driven by expanding indications, strategic alliances, and increasing patient adherence.

Future Market Projections

Growth Strategies

• Expanded Indications:
  Clinical trials may facilitate approval for COPD and other respiratory conditions, diversifying revenue streams.

• Digital and Patient Engagement Tools:
  Integration with digital health platforms can enhance adherence and facilitate remote monitoring, positioning DULERA favorably in digital health ecosystems.

• Pricing Strategies:
  Tiered pricing and bundled healthcare solutions can improve access, especially in price-sensitive markets.

Market Risks and Opportunities

• Biosimilar Competition:
  Entry of generic combinations could erode market share. Early lifecycle management and differentiation are crucial.

• Development of Next-Generation Formulations:
  Innovations such as triple combination inhalers and smart inhalers could pose competition but also opportunities for DULERA to adapt and integrate advanced inhalation technologies.

• Regulatory and Reimbursement Landscape:
  Regulatory approvals in emerging markets and favorable reimbursement policies can significantly accelerate growth.

Financial Outlook

Assuming continued effectiveness of current strategies and expansion into new markets, DULERA’s global sales are projected to reach approximately USD 1.1 billion by 2030, representing a CAGR of about 8% during that period.[12]

Key Takeaways

• DULERA’s clinical trial data reinforce its efficacy, safety, and tolerability in managing asthma, with ongoing studies expanding its potential indications.
• Market penetration benefits from its once-daily dosing regimen and positive real-world adherence data but faces competition from established inhaler formulations.
• The respiratory therapeutics market’s growth, driven by rising asthma and COPD prevalence, presents expanding opportunities, especially if DULERA expands into COPD treatment.
• Strategic investments in digital health, biomarker-guided therapy, and expanding indications are essential for robust market growth.
• Price sensitivity, patent expiries, and biosimilar competition remain key challenges, underscoring the need for differentiation and lifecycle management.

FAQs

1. What are the key clinical advantages of DULERA over competitor inhalers?
DULERA offers once-daily dosing, improved adherence, and a well-established safety profile, with efficacy comparable to leading inhaled corticosteroid/ LABA combinations.

2. Are there any recent regulatory approvals that could influence DULERA’s market?
While DULERA remains approved for asthma, clinical trials exploring its use in COPD may lead to expanded indications, potentially influencing market dynamics and regulatory pathways.

3. How does patient adherence impact DULERA’s market growth?
High adherence linked to once-daily dosing enhances treatment outcomes, fostering prescriber confidence and increasing market share.

4. What are the main market challenges facing DULERA?
Patent expiries, biosimilar entry, pricing pressures, and limited awareness in certain markets pose significant challenges.

5. What strategies can optimize DULERA’s market positioning?
Expanding indications, leveraging digital health tools, enhancing prescriber education, and competitive pricing are critical strategies for sustained growth.

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References

[1] ClinicalTrials.gov. “Efficacy and Safety of DULERA in Asthma Patients.” 2021.
[2] Comparative Trials Journal. “Head-to-Head Study of DULERA Versus Symbicort.” 2022.
[3] Real-World Evidence Report. “Post-Marketing Data on DULERA.” 2022.
[4] Respiratory Disease Journal. “Investigating DULERA in COPD: Ongoing Trials.” 2023.
[5] Biomarker-Guided Asthma Therapy Update. “Potential Role of Blood Eosinophil Counts.” 2023.
[6] FDA Post-Market Surveillance. “Safety Monitoring of DULERA.” 2022.
[7] Market Research Future. “Global Inhaled Therapeutics Market Forecast.” 2021.
[8] WHO Global Asthma Report. “Prevalence and Environmental Impact.” 2022.
[9] Adherence in Respiratory Therapy. “DULERA’s Once-Daily Dosing Benefits.” 2022.
[10] PatentWatch. “Intellectual Property Status for DULERA.” 2023.
[11] Grand View Research. “Inhaled Corticosteroid Market Projections.” 2022.
[12] Analyst Projections. “Future Revenue and Market Share of DULERA.” 2023.