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Last Updated: January 20, 2025

CLINICAL TRIALS PROFILE FOR FORMOTEROL FUMARATE; MOMETASONE FUROATE


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All Clinical Trials for Formoterol Fumarate; Mometasone Furoate

Trial IDTitleStatusSponsorPhaseStart DateSummary
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.
NCT00381485 ↗ Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED) Completed Novartis Phase 3 2006-07-01 This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg 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 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).
NCT00381485 ↗ Effects of Mometasone Furoate/Formoterol Combination Versus Mometasone Furoate Alone in Persistent Asthmatics (Study P04431AM2)(COMPLETED) Completed Merck Sharp & Dohme Corp. Phase 3 2006-07-01 This is a randomized, multicenter, double blind, parallel-group study evaluating the efficacy of mometasone furoate/formoterol fumarate (MF/F) metered dose inhaler (MDI) 400/10 mcg twice daily (BID) compared with MF MDI 400 mcg BID for 12 weeks. Prior to the 12-week double-blind treatment period, subjects will receive open-label MF MDI 400 mcg 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 hr) of the change from Baseline to the Week 12 Endpoint in forced expiratory volume in one second (FEV1).
>Trial ID>Title>Status>Phase>Start Date>Summary
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Clinical Trial Conditions for Formoterol Fumarate; Mometasone Furoate

Condition Name

122110024681012AsthmaChronic Obstructive Pulmonary Disease (COPD)Airway InflammationCOPD[disabled in preview]
Condition Name for Formoterol Fumarate; Mometasone Furoate
Intervention Trials
Asthma 12
Chronic Obstructive Pulmonary Disease (COPD) 2
Airway Inflammation 1
COPD 1
[disabled in preview] 0
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Condition MeSH

123220024681012AsthmaPulmonary Disease, Chronic ObstructiveLung DiseasesLung Diseases, Obstructive[disabled in preview]
Condition MeSH for Formoterol Fumarate; Mometasone Furoate
Intervention Trials
Asthma 12
Pulmonary Disease, Chronic Obstructive 3
Lung Diseases 2
Lung Diseases, Obstructive 2
[disabled in preview] 0
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Clinical Trial Locations for Formoterol Fumarate; Mometasone Furoate

Trials by Country

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Trials by Country for Formoterol Fumarate; Mometasone Furoate
Location Trials
United States 16
Colombia 2
Guatemala 1
Mexico 1
South Africa 1
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Trials by US State

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Trials by US State for Formoterol Fumarate; Mometasone Furoate
Location Trials
Florida 2
California 2
Wisconsin 1
Virginia 1
Texas 1
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Clinical Trial Progress for Formoterol Fumarate; Mometasone Furoate

Clinical Trial Phase

6.7%60.0%26.7%6.7%0123456789Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for Formoterol Fumarate; Mometasone Furoate
Clinical Trial Phase Trials
Phase 4 1
Phase 3 9
Phase 2 4
[disabled in preview] 1
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Clinical Trial Status

93.3%6.7%002468101214CompletedWithdrawn[disabled in preview]
Clinical Trial Status for Formoterol Fumarate; Mometasone Furoate
Clinical Trial Phase Trials
Completed 14
Withdrawn 1
[disabled in preview] 0
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Clinical Trial Sponsors for Formoterol Fumarate; Mometasone Furoate

Sponsor Name

trials02468101214Merck Sharp & Dohme Corp.NovartisSchering-Plough[disabled in preview]
Sponsor Name for Formoterol Fumarate; Mometasone Furoate
Sponsor Trials
Merck Sharp & Dohme Corp. 13
Novartis 8
Schering-Plough 2
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Sponsor Type

100.0%0-2024681012141618202224Industry[disabled in preview]
Sponsor Type for Formoterol Fumarate; Mometasone Furoate
Sponsor Trials
Industry 23
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Formoterol Fumarate and Mometasone Furoate: Clinical Trials, Market Analysis, and Projections

Introduction

Formoterol fumarate and mometasone furoate are two key components in the treatment of respiratory diseases, particularly asthma and chronic obstructive pulmonary disease (COPD). This article delves into recent clinical trials, market analysis, and future projections for these medications.

Clinical Trials Overview

Formoterol Fumarate in Combination Therapies

Formoterol fumarate, a long-acting beta 2-adrenergic agonist (LABA), is often used in combination with other medications to enhance therapeutic efficacy.

AERISTO Phase IIIb Trial

In the AERISTO Phase IIIb trial, Bevespi Aerosphere (glycopyrronium/formoterol fumarate) was compared to umeclidinium/vilanterol in patients with moderate to very severe COPD. While Bevespi Aerosphere demonstrated non-inferiority to umeclidinium/vilanterol on peak forced expiratory volume in one second (FEV1), it did not show superiority on peak FEV1 or non-inferiority on trough FEV1[1].

LABA Safety Trial

A significant study by Merck evaluated the safety of formoterol fumarate when combined with mometasone furoate in the DULERA Inhalation Aerosol. This 26-week trial showed that the addition of formoterol to mometasone maintenance therapy had a similar safety profile to mometasone alone, with a comparable risk of serious asthma-related events and a reduced risk of asthma exacerbations[2].

Mometasone Furoate in Combination Therapies

Mometasone furoate, an inhaled corticosteroid (ICS), is commonly paired with formoterol fumarate to treat asthma.

Efficacy and Safety Study in Children

A clinical trial comparing the 12-week efficacy and 24-week safety of mometasone furoate/formoterol fumarate (MF/F) versus mometasone furoate alone in children aged 5 to 11 years with persistent asthma is ongoing. This study aims to assess the efficacy and long-term safety of MF/F administered via metered-dose inhaler (MDI)[3].

Asthma Deteriorations and Lung Function

A 26-week, multicentre study evaluated the effect of MF/F versus its monocomponents on asthma deteriorations and lung function. The study found that MF/F significantly reduced asthma deteriorations and improved lung function compared to placebo, formoterol alone, and mometasone furoate alone[5].

Market Analysis

Current Market Landscape

The respiratory drug market is highly competitive, with several combination therapies available. The combination of formoterol fumarate and mometasone furoate, such as in DULERA, holds a significant market share due to its proven efficacy and safety profile.

Market Trends

There is a growing trend towards combination therapies that include both LABAs and ICSs. This is driven by the need for more effective and convenient treatments that can manage both symptoms and underlying inflammation in respiratory diseases.

Competitive Products

Other combination products like Bevespi Aerosphere and Symbicort Turbuhaler are also competing in the market. However, the unique formulation and delivery mechanism of MF/F combinations, such as DULERA, continue to make them a preferred choice for many healthcare providers.

Projections and Future Outlook

Increasing Demand

The demand for respiratory medications is expected to increase due to rising prevalence of asthma and COPD, particularly in urban and polluted areas. This trend is likely to drive the market for combination therapies like MF/F.

Regulatory Environment

Regulatory bodies continue to scrutinize the safety and efficacy of LABAs, which may impact future market dynamics. However, studies like the LABA safety trial by Merck have helped to alleviate some concerns, supporting the continued use of these combinations[2].

Innovations in Delivery Systems

Advancements in inhaler technology and delivery systems are expected to enhance patient compliance and treatment outcomes. New formulations and devices that improve drug delivery and ease of use will be crucial in the future market.

Key Takeaways

  • Clinical Efficacy: Formoterol fumarate and mometasone furoate combinations have demonstrated significant efficacy in reducing asthma exacerbations and improving lung function.
  • Safety Profile: Studies have shown that these combinations have a favorable safety profile, comparable to or better than monotherapies.
  • Market Trends: The market is shifting towards combination therapies, driven by the need for effective and convenient treatments.
  • Future Outlook: Increasing demand and advancements in delivery systems are expected to drive the market for these medications.

FAQs

What is the primary use of formoterol fumarate in respiratory diseases?

Formoterol fumarate is primarily used as a long-acting beta 2-adrenergic agonist (LABA) to manage symptoms of asthma and COPD by relaxing airway muscles.

How does mometasone furoate work in combination with formoterol fumarate?

Mometasone furoate, an inhaled corticosteroid (ICS), works by reducing inflammation in the airways, while formoterol fumarate helps to relax airway muscles, providing both symptom relief and anti-inflammatory effects.

What are the key findings from the LABA safety trial by Merck?

The trial found that the addition of formoterol to mometasone maintenance therapy had a similar safety profile to mometasone alone, with a comparable risk of serious asthma-related events and a reduced risk of asthma exacerbations[2].

Are there any ongoing clinical trials for MF/F combinations in pediatric patients?

Yes, there is an ongoing study comparing the efficacy and safety of MF/F versus mometasone furoate alone in children aged 5 to 11 years with persistent asthma[3].

What are the projected market trends for respiratory combination therapies?

The market is expected to grow due to increasing demand driven by the rising prevalence of respiratory diseases and advancements in inhaler technology and delivery systems.

Sources

  1. AstraZeneca, "AstraZeneca provides update on AERISTO Phase IIIb trial for Bevespi Aerosphere (glycopyrronium/formoterol fumarate) in chronic obstructive pulmonary disease," August 23, 2018.
  2. Merck, "Merck Announces Top-Line Results from the Long Term LABA Safety Study of DULERA (mometasone furoate and formoterol fumarate dihydrate) Inhalation Aerosol," May 22, 2017.
  3. ClinicalTrials.gov, "Study of Efficacy and Long-Term Safety of Mometasone Furoate in Combination with Formoterol Fumarate," May 16, 2024.
  4. EudraCT, "A Randomized, Open-Label, Two Period Crossover, Chronic Dosing, 1-Week, Pilot Study to Assess the Efficacy and Safety of Budesonide and Formoterol Fumarate MDI," September 10, 2019.
  5. European Respiratory Journal, "Mometasone furoate/formoterol reduces asthma deteriorations and improves lung function," 2017.

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