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.

Clinical Trial Conditions for Foradil

Condition Name

Condition Name for Foradil
Intervention	Trials
Asthma	10
Chronic Obstructive Pulmonary Disease	8
Chronic Obstructive Pulmonary Disease (COPD)	4
Pulmonary Disease, Chronic Obstructive	4

Condition MeSH

Condition MeSH for Foradil
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	19
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
Phase 4	3
Phase 3	13
Phase 2	11

Clinical Trial Status

Clinical Trial Status for Foradil
Clinical Trial Phase	Trials
Completed	28
Terminated	3
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	32
Other	25
U.S. Fed	1

Formoterol Fumarate: Clinical Trials, Market Analysis, and Projections for FORADIL

Introduction to Formoterol Fumarate and FORADIL

Formoterol fumarate, the active ingredient in FORADIL AEROLIZER, is a long-acting beta2-adrenergic agonist (LABA) used in the treatment of asthma and chronic obstructive pulmonary disease (COPD). Here, we will delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Asthma Trials

Clinical trials involving FORADIL AEROLIZER have demonstrated its efficacy in treating asthma. In two pivotal, 12-week, multi-center, randomized, double-blind, parallel group studies, FORADIL AEROLIZER 12 mcg twice daily showed significantly greater post-dose bronchodilation compared to placebo and albuterol 180 mcg four times daily by metered-dose inhaler. These studies included 1095 adult and adolescent patients with mild-to-moderate asthma, and the results indicated that FORADIL AEROLIZER maintained its bronchodilatory effect for up to 12 hours post-dose[1].

In pediatric patients, a three-month, double-blind, double-dummy study compared the efficacy and safety of 12 µg twice daily of Formoterol-HFA and 12 µg twice daily of Formoterol-DPI (Foradil/Aerolizer). This study found that both formulations provided similar efficacy in children with persistent asthma[4].

COPD Trials

In patients with COPD, FORADIL AEROLIZER 12 mcg twice daily was shown to provide significant bronchodilation within 5 minutes of inhalation and maintained this effect for at least 12 hours. Two pivotal, double-blind, placebo-controlled trials involving 1634 adult patients with COPD confirmed that FORADIL AEROLIZER resulted in significantly greater post-dose bronchodilation compared to placebo over 12 weeks and 12 months[1].

Exercise-Induced Bronchospasm Trials

FORADIL AEROLIZER has also been evaluated for its effectiveness in preventing exercise-induced bronchospasm. In four randomized, single-dose, double-blind, crossover studies involving 77 patients, FORADIL AEROLIZER 12 mcg maintained superiority over placebo in preventing bronchospasm for up to 12 hours post-administration[1].

Combination Therapies

Recent clinical trials have explored the efficacy of combining formoterol fumarate with other bronchodilators. A pivotal Phase III clinical trial by Almirall and Forest Laboratories evaluated the fixed-dose combination of aclidinium bromide (a long-acting muscarinic antagonist, LAMA) and formoterol fumarate. The study found that the combination of aclidinium/formoterol (400/6mcg and 400/12mcg) given twice daily demonstrated statistically significant improvements in lung function compared to monotherapy with either drug alone or placebo. This combination was well-tolerated, with adverse events similar to those of the individual components[3].

Market Analysis

Market Size and Growth

The global formoterol fumarate market is projected to experience significant growth from 2023 to 2030, driven by increasing pollution levels, rising incidence of respiratory diseases, and growing awareness of asthma treatment. The market is expected to expand due to factors such as poor air quality, lack of exercise, and unhealthy dietary habits, which contribute to the increasing number of patients suffering from respiratory issues[2].

Geographic Segmentation

The global formoterol fumarate market is segmented geographically into North America, Europe, Asia Pacific, and the Rest of the World. North America, particularly the United States, holds the largest share of the market due to early adoption of asthma treatments and a high incidence of asthma. The Asia Pacific region is also expected to see significant growth due to increasing awareness and treatment adoption[2].

Key Players

The market is dominated by several key players, including Cipla Inc., Inke, Fermion, Beaukev Pharma International Pvt. Ltd., Astra Zeneca, Mylan, Nilkanth Organics, and Hovione. These companies are focusing on strategic developments, market share expansion, and innovative product offerings to maintain their competitive edge[2].

Market Projections

Future Growth

The formoterol fumarate market is anticipated to grow substantially over the forecast period, driven by the increasing demand for effective respiratory treatments. The rising prevalence of asthma and COPD, coupled with advancements in inhalation technologies and combination therapies, will continue to drive market growth[2].

Opportunities and Challenges

Opportunities in the market include the development of new inhaler devices and combination therapies that offer improved efficacy and patient compliance. However, challenges such as regulatory hurdles, competition from generic drugs, and the need for continuous innovation to stay ahead in the market will need to be addressed by key players.

Regional Expansion

The market is expected to expand in regions with growing healthcare infrastructure and increasing awareness of respiratory diseases. Asia Pacific and Latin America are likely to be key growth areas due to their large populations and rising healthcare spending.

Key Takeaways

• Clinical Efficacy: FORADIL AEROLIZER has demonstrated significant bronchodilation in both asthma and COPD patients, with effects lasting up to 12 hours.
• Combination Therapies: The combination of formoterol fumarate with other bronchodilators, such as aclidinium bromide, shows promising results in clinical trials.
• Market Growth: The global formoterol fumarate market is projected to grow significantly due to increasing respiratory disease prevalence and advancements in treatment options.
• Geographic Focus: North America and the Asia Pacific region are key markets, with the latter expected to see significant growth.
• Competitive Landscape: Major players are focusing on innovative products and strategic developments to maintain market share.

FAQs

What is the primary use of FORADIL AEROLIZER?

FORADIL AEROLIZER is primarily used for the treatment of asthma and chronic obstructive pulmonary disease (COPD) by providing long-acting bronchodilation.

How does FORADIL AEROLIZER compare to other bronchodilators?

FORADIL AEROLIZER has been shown to provide significant bronchodilation comparable to or superior to other bronchodilators like albuterol, with effects lasting up to 12 hours[1].

What are the common adverse effects of FORADIL AEROLIZER?

Common adverse effects include nasopharyngitis, back pain, and other typical respiratory medication side effects, which are generally well-tolerated[3].

How does the combination of formoterol fumarate with aclidinium bromide perform in clinical trials?

The combination of aclidinium/formoterol has demonstrated statistically significant improvements in lung function compared to monotherapy with either drug alone or placebo, with a comparable safety profile[3].

What are the key drivers of the formoterol fumarate market growth?

The market is driven by increasing pollution levels, rising incidence of respiratory diseases, growing awareness of asthma treatment, and advancements in inhalation technologies and combination therapies[2].

Sources

1. FORADIL AEROLIZER Label - FDA.
2. Formoterol Fumarate Market Size, Share, Opportunities & Forecast - Verified Market Research.
3. Forest Laboratories, Inc. and Almirall Report Positive COPD Drug Data - Biospace.
4. EU Clinical Trials Register - EudraCT Number 2004-000755-41.