CLINICAL TRIALS PROFILE FOR FORADIL

All Clinical Trials for FORADIL

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00250679 ↗	Safety and Efficacy of Arformoterol Tartrate Inhalation Solution in Subjects With Chronic Obstructive Pulmonary Disease	Completed	Sunovion	Phase 3	2005-10-01	To evaluate the long-term safety and monitor the long-term efficacy of arformoterol over a period of 6 months in subjects with chronic obstructive pulmonary disease (COPD).
NCT00383240 ↗	Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)	Completed	Novartis	Phase 3	2006-09-01	This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)[MF/F] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hours) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) [Time Frame: Baseline to Week 12] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.
NCT00383240 ↗	Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04334AM1)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-09-01	This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate (MF) /formoterol fumarate (F)[MF/F] metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, subjects will receive open-label MF MDI 200 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by The Area Under the Curve From 0 to 12 Hours [AUC](0-12 hours) of the Change From Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) [Time Frame: Baseline to Week 12] and Time-to-First Severe Asthma Exacerbation across the 26-week treatment period.
NCT00383435 ↗	Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)	Completed	Novartis	Phase 3	2006-10-01	This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated subjects who will not participate in the safety extension will be discontinued and will have their Final Visit at Week 26. Subjects who continue into the 26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12hr]) and change from Baseline to Week 13 in AM predose FEV1.
NCT00383435 ↗	Effects of Mometasone Furoate/Formoterol Combination Versus Formoterol and Mometasone Furoate Alone in COPD (Study P04229AM4)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-10-01	This is a randomized, placebo-controlled, parallel-group, multi-site, double-blind study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) and MF/F MDI 200/10 mcg BID compared with MF 400 mcg BID and F 10 mcg BID in adults at least 40 years of age, with moderate to severe chronic obstructive pulmonary disease (COPD). All placebo-treated subjects and active-treated subjects who will not participate in the safety extension will be discontinued and will have their Final Visit at Week 26. Subjects who continue into the 26-week safety extension will have their Final Visit at Week 52. Efficacy will be measured by the mean change from Baseline to Week 13 in area under the forced expiratory volume in one second concentration time curve from 0 to 12 hours (FEV1 AUC[0-12hr]) and change from Baseline to Week 13 in AM predose FEV1.
NCT00383552 ↗	Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)	Completed	Novartis	Phase 3	2006-09-01	This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, participants will receive open-label (OL) MF MDI 100 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by the Area Under the Curve from 0 to 12 hours [AUC](0-12 hours) of the change from Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) and by the time-to-first severe asthma exacerbation across the 26-week treatment period.
NCT00383552 ↗	Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04073AM1)(COMPLETED)	Completed	Merck Sharp & Dohme Corp.	Phase 3	2006-09-01	This is a randomized, multi-center, double-blind, double-dummy, placebo-controlled, parallel-group study, evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) versus MF for 26 weeks. Prior to the 26-week double-blind Treatment Period, participants will receive open-label (OL) MF MDI 100 mcg twice daily (BID) for 2 to 3 weeks during the Run-in Period. Efficacy will be measured by the Area Under the Curve from 0 to 12 hours [AUC](0-12 hours) of the change from Baseline to the Week 12 Endpoint in Forced Expiratory Volume in One Second (FEV1) and by the time-to-first severe asthma exacerbation across the 26-week treatment period.

Clinical Trial Conditions for FORADIL

Condition Name

Condition Name for FORADIL
Intervention	Trials
Asthma	10
Chronic Obstructive Pulmonary Disease	9
Pulmonary Disease, Chronic Obstructive	4
Chronic Obstructive Pulmonary Disease (COPD)	4

Condition MeSH

Condition MeSH for FORADIL
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	20
Lung Diseases, Obstructive	18
Lung Diseases	17
Asthma	10

Clinical Trial Locations for FORADIL

Trials by Country

Trials by Country for FORADIL
Location	Trials
United States	138
Canada	13
Australia	12
New Zealand	8
South Africa	7

Trials by US State

Trials by US State for FORADIL
Location	Trials
Florida	14
South Carolina	13
North Carolina	8
California	7
Texas	6

Clinical Trial Progress for FORADIL

Clinical Trial Phase

Clinical Trial Phase for FORADIL
Clinical Trial Phase	Trials
PHASE4	1
Phase 4	3
Phase 3	13

Clinical Trial Status

Clinical Trial Status for FORADIL
Clinical Trial Phase	Trials
Completed	28
Terminated	4
Withdrawn	2

Clinical Trial Sponsors for FORADIL

Sponsor Name

Sponsor Name for FORADIL
Sponsor	Trials
Merck Sharp & Dohme Corp.	5
Pearl Therapeutics, Inc.	5
Novartis	4

Sponsor Type

Sponsor Type for FORADIL
Sponsor	Trials
Industry	33
Other	26
U.S. Fed	1

FORADIL: Clinical Trials Update, Market Analysis, and Outlook

Last updated: February 21, 2026

What are the latest developments in FORADIL's clinical trial program?

FORADIL (formoterol fumarate dihydrate) is a long-acting beta-2 adrenergic receptor agonist approved primarily for asthma and chronic obstructive pulmonary disease (COPD). Its development history indicates a focus on sustained bronchodilation with inhalation therapy.

Clinical Trial Status (as of Q1 2023):

• Phase III Trials: No active Phase III trials listed on clinicaltrials.gov for FORADIL, indicating completion or suspension.
• Post-approval studies: Limited post-market surveillance studies have been conducted to assess long-term safety, with data published in peer-reviewed journals.
• New indications: No recent trials exploring alternative indications or combination therapy reported publicly.

Historical Data:

• Primary studies: Pivotal trials from 2004 to 2006 demonstrated efficacy in reducing exacerbations in COPD patients.
• Safety Profile: Long-term use associated with typical beta-agonist side effects; no major safety concerns emerged beyond known adverse events.

How does the clinical research landscape influence market prospects?

The absence of recent Phase III trials or new indications suggests limited ongoing R&D activity, which impacts future market expansion potential. Current approval covers inhalation therapy for COPD and asthma, with no significant pipeline developments indicating a lack of recent innovation or line extension.

What is the current market size for FORADIL and its key competitors?

Market Size (2018–2023):

Year	Global COPD/Asthma inhaler market (USD billion)	FORADIL's estimated share per sales data (USD million)
2018	23.5	120-150 (estimated)
2019	25.2	125-155
2020	27.0	130-165
2021	29.0	135-170
2022	31.0	140-180

Note: FORADIL sales are estimated based on market share, competitive dynamics, and prescription trends.

Key Competitors:

• Salmeterol (Serevent Diskus): Immediate market leader.
• Formoterol (Perforomist): Another long-acting beta-agonist with significant market share.
• Indacaterol (Arcapta Neohaler): Competitor with once-daily dosing.

Market Trends:

• Inhaled corticosteroid/long-acting beta-agonist (ICS/LABA) combination therapies are increasingly prescribed, gradually reducing dependence on monotherapies like FORADIL.
• Rising global prevalence of COPD and asthma amplifies inhaler market potential, but innovative formulations have gained preference.

What are the projections for FORADIL’s future sales and market presence?

Short-term (2023–2025):

• Anticipate flat or declining sales attributable to:
  • Limited new indications.
  • Competition from established combination therapies.
  • Patent expiration for some formulations, increasing generic competition.

Long-term (2026+):

• Market share unlikely to expand unless new formulations or indications appear.
• Potential for decline if competitors introduce more convenient or effective inhaler devices.
• Growth prospects depend on lifecycle management strategies, such as reformulation or combination products.

Regulatory and Market Dynamics:

• Patent expiry: Foradil's primary patents have expired or are nearing expiry in key markets like the US and EU.
• Generic entry: Expected to exert downward pressure on pricing.
• Market access: Increasing reimbursement pressure favors combination therapies with proven efficacy and safety profiles.

What are the key regulatory considerations?

• The European Medicines Agency (EMA) and U.S. Food and Drug Administration (FDA) approved FORADIL in early- to mid-2000s.
• No recent approvals or new indications documented; marketing authorization renewal is ongoing in mature markets.
• Future approvals would require extensive clinical data, especially for new indications or formulations.

Summary: Market outlook and strategic implications

• The absence of pipeline activity, new indications, or formulations indicates a mature product facing stagnant growth.
• Market share is declining amid patent cliffs and the rise of combination therapies.
• Companies may consider repositioning or reformulating for niche indications or pediatric use to extend product lifecycle.

Key Takeaways

• FORADIL remains marketed primarily for COPD and asthma, with no recent clinical trials or pipeline updates.
• Estimated market share has stabilized but is poised to decline due to generic competition and shifting prescribing trends.
• Long-term growth prospects are limited unless new formulations or indications are pursued.
• Competitive landscape favors combination inhalers, reducing monotherapy relevance.
• Patent expiration and regulatory factors suggest decreasing exclusivity and market presence.

FAQs

1. Why are no recent clinical trials for FORADIL reported?
The original trials established efficacy; current data suggests a focus on market maintenance rather than new development.

2. Will FORADIL remain a viable product in the next five years?
Likely, but sales will decline unless marketed as part of combination therapy or reformulated for new indications.

3. How does FORADIL compare to its competitors?
It has similar efficacy to other long-acting beta-agonists but lacks advantages in convenience or additional indications.

4. What factors influence future sales of FORADIL?
Patent status, competition, regulatory landscape, and adoption of newer combination inhalers.

5. Are there opportunities to expand FORADIL’s market?
Potential exists in pediatric applications or as part of combination therapies, but no recent evidence supports active development in these areas.

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References

1. ClinicalTrials.gov. (2023). FORADIL clinical trials. Retrieved from https://clinicaltrials.gov/
2. MarketResearch.com. (2023). Global COPD and asthma inhaler market report.
3. FDA. (2017). New drug approvals: Formoterol.
4. EMA. (2015). Summary of product characteristics for FORADIL.
5. Grand View Research. (2023). Inhalers market size and forecast.