CLINICAL TRIALS PROFILE FOR PERFOROMIST

All Clinical Trials for Perforomist

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00633776 ↗	Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT)	Withdrawn	Dey, L.P.	Phase 4	2008-03-01	The purpose of this study is to compare the effects of nebulized formoterol fumarate (Perforomist) to dry-powder inhaler formoterol fumarate (Foradil). Perforomist is a solution that is made into very fine spray (using a nebulizer) that is then breathed in over 10-15 minutes. Foradil is taken in a single quick, deep inhalation.
NCT00633776 ↗	Perforomist Versus Foradil Evaluated by Inspiratory Capacity and High Resolution Computed Tomography (HRCT)	Withdrawn	University of California, Los Angeles	Phase 4	2008-03-01	The purpose of this study is to compare the effects of nebulized formoterol fumarate (Perforomist) to dry-powder inhaler formoterol fumarate (Foradil). Perforomist is a solution that is made into very fine spray (using a nebulizer) that is then breathed in over 10-15 minutes. Foradil is taken in a single quick, deep inhalation.
NCT01488019 ↗	Study to Evaluate the Safety of Long-Term Use of Perforomist® (Formoterol Fumarate)	Completed	Dey	Phase 4	2012-03-01	This study is a multi-center, randomized, placebo-controlled study to evaluate the long-term safety of Perforomist® inhalation therapy in subjects with Chronic Obstructive Pulmonary Disease (COPD). Individual participation is approximately 54 weeks, including 52 weeks of double-blind treatment.
NCT02291016 ↗	COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers	Completed	Mylan Specialty L.P.	N/A	2015-02-01	The purpose of this study is to compare drug delivery and lung function after treatment with formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from severe exacerbations of COPD. This is to determine if one device is superior in providing better lung function and drug deposition in this clinical setting.
NCT02291016 ↗	COPD Aerosol Study Comparing the Efficacy of Nebulizers Versus Dry Powder Inhalers	Completed	University of Tennessee Graduate School of Medicine	N/A	2015-02-01	The purpose of this study is to compare drug delivery and lung function after treatment with formoterol from a nebulizer versus a dry powder inhaler (DPI) in patients recovering from severe exacerbations of COPD. This is to determine if one device is superior in providing better lung function and drug deposition in this clinical setting.
NCT02796651 ↗	Formoterol Dose Ranging Study (ACHIEVE Duaklir USA Phase IIb)	Completed	Parexel	Phase 2	2016-06-30	To assess the bronchodilation of three doses of formoterol fumarate (6 μg, 12 μg and 24 μg) twice daily (BID) administered via Pressair® compared to placebo and to open-label nebulized formoterol fumarate (20 μg and 40 μg).

Clinical Trial Conditions for Perforomist

Condition Name

Condition Name for Perforomist
Intervention	Trials
Chronic Obstructive Pulmonary Disease (COPD)	2
COPD	2
Asthma	1
Chronic Bronchitis	1

Condition MeSH

Condition MeSH for Perforomist
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	5
Lung Diseases, Obstructive	4
Lung Diseases	3
Bronchitis, Chronic	1

Clinical Trial Locations for Perforomist

Trials by Country

Trials by Country for Perforomist
Location	Trials
United States	28

Trials by US State

Trials by US State for Perforomist
Location	Trials
South Carolina	4
Missouri	3
Florida	3
North Carolina	3
Arizona	2

Clinical Trial Progress for Perforomist

Clinical Trial Phase

Clinical Trial Phase for Perforomist
Clinical Trial Phase	Trials
Phase 4	2
Phase 3	1
Phase 2	2

Clinical Trial Status

Clinical Trial Status for Perforomist
Clinical Trial Phase	Trials
Completed	5
Withdrawn	1

Clinical Trial Sponsors for Perforomist

Sponsor Name

Sponsor Name for Perforomist
Sponsor	Trials
Theravance Biopharma	2
Mylan Inc.	2
Dey, L.P.	1

Sponsor Type

Sponsor Type for Perforomist
Sponsor	Trials
Industry	8
Other	4

PERFOROMIST: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

PERFOROMIST (formoterol fumarate) Inhalation Solution is a long-acting beta2-adrenergic agonist (LABA) designed for the long-term maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema. Here, we delve into the clinical trials, market analysis, and future projections for this medication.

Clinical Trials Overview

Phase III Pivotal Trial

The efficacy and safety of PERFOROMIST were established through a 12-week, randomized, double-blind, placebo- and active-controlled trial. This study involved 351 patients with COPD, divided into three groups: 123 patients treated with PERFOROMIST 20 mcg/2 mL twice daily, 114 patients treated with the active comparator (Foradil®), and 114 patients treated with placebo[1][2][4].

Key Findings

• Bronchodilation: PERFOROMIST provided rapid bronchodilation that lasted a full 12 hours, with a median time to onset of 11.7 minutes and a median time to peak effect of 2 hours after dosing[1][2].
• Lung Function: The treatment maintained improvements in lung function over the 12-week period with no evidence of tolerance (tachyphylaxis)[1].
• Rescue Medication: Patients treated with PERFOROMIST used less rescue albuterol compared to those treated with placebo[1][2].
• Quality of Life: PERFOROMIST improved lung function and quality of life compared to placebo, aligning with the GOLD Guidelines for COPD treatment[1].

Safety Profile

The safety results showed that PERFOROMIST was well tolerated, with a safety profile similar to that of Foradil®. It resulted in fewer COPD exacerbations than placebo and did not show significant cardiac effects, which is crucial for patients with many serious co-morbidities[1][2].

Market Analysis

Market Positioning

PERFOROMIST is the first nebulized version of the LABA formoterol fumarate, previously available as a dry powder formulation (Foradil®). It is co-marketed by Dey Labs (a Mylan subsidiary) and Critical Therapeutics, targeting a familiar physician base, including pulmonologists and hospital-based doctors[2].

Competitive Landscape

In the inhalable drugs market, PERFOROMIST competes with other nebulized LABAs like Brovana. The market is dominated by dry powder formulations, but the spray segment, which includes nebulized solutions like PERFOROMIST, is growing at a robust CAGR of 7.8% from 2024 to 2034[5].

Market Growth Factors

• Rapid Onset of Action: Inhalable drugs like PERFOROMIST offer a rapid onset of action, which is a significant growth factor in the market.
• Targeted Delivery: The ability to deliver drugs directly to the lungs enhances the efficacy and bioavailability of the medication.
• High Bioavailability: Inhalable drugs generally have higher bioavailability compared to ingested drugs, leading to faster and more effective treatment outcomes[5].

Market Projections

Global Inhalable Drugs Market

The global inhalable drugs market is expected to grow significantly, reaching around USD 65.51 billion by 2034. The respiratory diseases segment, which includes COPD treatments like PERFOROMIST, accounts for the largest market share, driven by the need for local treatment to suppress and prevent inflammation and bronchoconstriction[5].

Segment Growth

The spray segment, which includes nebulized solutions, is anticipated to grow at a robust CAGR during the forecast period. This growth is attributed to the direct delivery of the drug to the treatment site, offering a rapid rate of action compared to oral drugs[5].

Adverse Reactions and Precautions

Common Adverse Reactions

Common adverse reactions associated with PERFOROMIST include GI upset, nasopharyngitis, dry mouth, dizziness, and insomnia. Cardiovascular effects such as increased blood pressure and tachycardia can also occur, although they are less frequent[2][3].

Contraindications

PERFOROMIST is contraindicated for the treatment of acute attacks or asthma and should not be initiated in patients with significantly worsening or acutely deteriorating COPD. It is also contraindicated for use with other long-acting beta2-agonists[3].

Dosage and Administration

Recommended Dosage

The recommended dosage for PERFOROMIST is 20 mcg (1 vial) by nebulizer twice daily, once in the morning and once in the evening. It should be used with a standard jet nebulizer and air compressor, and it does not need to be diluted before nebulization[2][3].

Key Takeaways

• Effective Bronchodilation: PERFOROMIST provides rapid and sustained bronchodilation for 12 hours.
• Improved Quality of Life: It enhances lung function and quality of life for COPD patients.
• Safety Profile: The medication is well tolerated with a safety profile similar to other LABAs.
• Market Growth: The inhalable drugs market, particularly the spray segment, is expected to grow significantly.
• Targeted Delivery: PERFOROMIST offers targeted delivery to the lungs, increasing its efficacy and bioavailability.

FAQs

Q: What is PERFOROMIST used for?

A: PERFOROMIST is used for the long-term maintenance treatment of bronchoconstriction in patients with Chronic Obstructive Pulmonary Disease (COPD), including chronic bronchitis and emphysema.

Q: How is PERFOROMIST administered?

A: PERFOROMIST is administered via nebulization, using a standard jet nebulizer and air compressor, twice daily (20 mcg per dose).

Q: What are the common adverse reactions associated with PERFOROMIST?

A: Common adverse reactions include GI upset, nasopharyngitis, dry mouth, dizziness, and insomnia.

Q: Can PERFOROMIST be used to treat acute asthma attacks?

A: No, PERFOROMIST is not indicated for the treatment of acute asthma attacks or acute deteriorations of COPD.

Q: How does PERFOROMIST compare to other LABAs in terms of safety and efficacy?

A: PERFOROMIST has a safety profile similar to that of Foradil®, another LABA, and it is as effective in maintaining lung function and reducing the need for rescue medication.

Sources

1. EurekAlert - Clinical trial data for Perforomist Inhalation Solution[1].
2. MM+M - Perforomist[2].
3. Drugs.com - Perforomist: Package Insert / Prescribing Information[3].
4. FDA - PERFOROMIST (formoterol fumarate) label[4].
5. Biospace - Inhalable Drugs Market Size to Worth Around USD 65.51 Bn by 2034[5].