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Last Updated: April 14, 2025

CLINICAL TRIALS PROFILE FOR ARFORMOTEROL TARTRATE


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All Clinical Trials for arformoterol tartrate

Trial IDTitleStatusSponsorPhaseStart DateSummary
NCT00583947 ↗ A Safety and Tolerability Study of Arformoterol Tartrate Inhalation Solution in Pediatric Subjects Completed Sunovion Phase 2 2008-01-01 To determine the safety and tolerability of Arformoterol Tartrate in children with asthma
NCT00571428 ↗ Efficacy Safety Study of Arformoterol QD Dosing Versus BID Dosing in COPD Completed Sunovion Phase 4 2007-11-01 To evaluate the efficacy and safety of arformoterol tartrate inhalation solution 30μg/4mL QD (two 15μg/2mL dosed in combination) over a 24-hour period compared to arformoterol tartrate inhalation solution 15μg/2 mL BID in subjects with COPD.
NCT00424528 ↗ Efficacy Safety Study of Arformoterol/Tiotropium Combination Versus Either Therapy Alone in Chronic Obstructive Pulmonary Disease (COPD) Completed Sunovion Phase 4 2006-12-01 The purpose of this study is to evaluate and compare the efficacy of arformoterol twice a day and tiotropium once a day (dosed sequentially) versus tiotropium once a day alone in subjects with Chronic Obstructive Pulmonary Disease (COPD).
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).
>Trial ID>Title>Status>Phase>Start Date>Summary
Showing 1 to 4 of 4 entries

Clinical Trial Conditions for arformoterol tartrate

Condition Name

632200123456Chronic Obstructive Pulmonary DiseaseEmphysemaBronchitisCOPD[disabled in preview]
Condition Name for arformoterol tartrate
Intervention Trials
Chronic Obstructive Pulmonary Disease 6
Emphysema 3
Bronchitis 2
COPD 2
[disabled in preview] 0
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Condition MeSH

88830012345678Pulmonary Disease, Chronic ObstructiveLung Diseases, ObstructiveLung DiseasesPulmonary Emphysema[disabled in preview]
Condition MeSH for arformoterol tartrate
Intervention Trials
Pulmonary Disease, Chronic Obstructive 8
Lung Diseases, Obstructive 8
Lung Diseases 8
Pulmonary Emphysema 3
[disabled in preview] 0
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Clinical Trial Locations for arformoterol tartrate

Trials by Country

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Trials by Country for arformoterol tartrate
Location Trials
United States 105
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Trials by US State

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Trials by US State for arformoterol tartrate
Location Trials
South Carolina 7
California 6
Florida 5
Washington 5
Pennsylvania 5
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Clinical Trial Progress for arformoterol tartrate

Clinical Trial Phase

55.6%22.2%22.2%0-0.500.511.522.533.544.555.5Phase 4Phase 3Phase 2[disabled in preview]
Clinical Trial Phase for arformoterol tartrate
Clinical Trial Phase Trials
Phase 4 5
Phase 3 2
Phase 2 2
[disabled in preview] 0
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Clinical Trial Status

77.8%11.1%11.1%001234567CompletedTerminatedUnknown status[disabled in preview]
Clinical Trial Status for arformoterol tartrate
Clinical Trial Phase Trials
Completed 7
Terminated 1
Unknown status 1
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Clinical Trial Sponsors for arformoterol tartrate

Sponsor Name

trials0123456789SunovionDartmouth-Hitchcock Medical CenterUniversity of California, Los Angeles[disabled in preview]
Sponsor Name for arformoterol tartrate
Sponsor Trials
Sunovion 9
Dartmouth-Hitchcock Medical Center 1
University of California, Los Angeles 1
[disabled in preview] 0
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Sponsor Type

81.8%18.2%00123456789IndustryOther[disabled in preview]
Sponsor Type for arformoterol tartrate
Sponsor Trials
Industry 9
Other 2
[disabled in preview] 0
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Arformoterol Tartrate: Clinical Trials, Market Analysis, and Projections

Introduction

Arformoterol Tartrate, a long-acting β2-agonist (LABA), is widely used in the maintenance treatment of Chronic Obstructive Pulmonary Disease (COPD). This article delves into the clinical trials, market analysis, and future projections for this drug.

Clinical Trials Overview

Short-Term Trials

Arformoterol Tartrate Inhalation Solution has been evaluated in several short-term clinical trials. Two 12-week, placebo-controlled trials involved 1,456 patients with COPD, who were treated with various doses of Arformoterol Tartrate (15 mcg twice daily, 25 mcg twice daily, and 50 mcg once daily) or placebo. These trials showed that Arformoterol Tartrate improved lung function and reduced the frequency of COPD exacerbations compared to placebo. The adverse event profile was generally favorable, with common adverse events including pain, chest pain, back pain, and diarrhea[1].

Long-Term Trials

A one-year, double-blind, randomized, placebo-controlled study demonstrated significant benefits of Arformoterol Tartrate. This study involved 841 patients and showed that Arformoterol Tartrate reduced the risk of respiratory death or COPD exacerbation-related hospitalization by approximately 40% compared to placebo. The drug also improved lung function, as measured by FEV1 and FVC, and enhanced quality of life as assessed by the St. George's Hospital Respiratory Questionnaire and the Clinical COPD Questionnaire[3].

Safety and Tolerability

Cardiovascular Effects

Arformoterol Tartrate, like other LABAs, should be used cautiously in patients with cardiovascular disorders. Clinical trials have shown that while there were no significant increases in specific cardiovascular adverse events, there were general changes in blood pressure and pulse rate. For instance, a one-year study showed a minimal increase in QTc-F interval compared to the active comparator, salmeterol[1].

Other Safety Considerations

The drug is also used with caution in patients with convulsive disorders, thyrotoxicosis, and those who are unusually responsive to sympathomimetic amines. The overall frequency of cardiovascular adverse events was lower in the Arformoterol Tartrate group compared to the placebo group in short-term trials[1].

Market Analysis

Market Size and Growth

The Arformoterol Tartrate API market is expected to experience exponential growth from 2023 to 2030, driven by increasing demand for inhalation solutions and other applications. The market estimates are based on a comprehensive research methodology that includes primary and secondary research, as well as expert advice. Key players such as INKE SA, GLENMARK LIFE SCIENCES LTD, MSN LABORATORIES PRIVATE LTD, and CIPLA LTD are significant contributors to this market[2].

Regional and Country-Level Analysis

The market report provides insights into lucrative opportunities at the country and regional levels. Factors such as product pricing, market dynamics, country GDP, and consumer buying behavior are considered in the analysis. The report is segmented to offer a detailed analysis from various aspects, including type, application, and geography[2].

Competitive Landscape

The global Arformoterol market is competitive, with several key players involved in the production and distribution of Arformoterol Tartrate API. The market report includes competitor analysis, regional analysis, and segment analysis to provide a comprehensive view of the market landscape[5].

Market Projections

Forecast Period

The market size and revenue for Arformoterol Tartrate API are forecasted to grow significantly from 2025 to 2031. The base year for these calculations is 2023, with historical data from 2019 to 2023. The forecast period includes detailed analyses of market trends, drivers, opportunities, and restraints[5].

Segment Analysis

By type, the inhalation solution segment is expected to account for the largest share of the global Arformoterol market. This is due to the increasing demand for effective COPD management and the preference for inhalation solutions as a delivery method[5].

Regional Dominance

The region expected to dominate the global Arformoterol market within the forecast period is likely to be driven by factors such as market size, revenue, and growth rate. Regions with high prevalence of COPD and advanced healthcare infrastructure are anticipated to lead the market[5].

Key Takeaways

  • Clinical Efficacy: Arformoterol Tartrate has demonstrated significant clinical benefits in reducing COPD exacerbations and improving lung function.
  • Safety Profile: The drug is generally well-tolerated but should be used cautiously in patients with certain cardiovascular and other conditions.
  • Market Growth: The Arformoterol Tartrate API market is projected to grow exponentially from 2023 to 2030, driven by increasing demand and favorable market dynamics.
  • Competitive Landscape: The market is competitive with several key players, and regional analysis indicates varying market opportunities.

FAQs

What are the primary clinical benefits of Arformoterol Tartrate?

Arformoterol Tartrate reduces the risk of respiratory death or COPD exacerbation-related hospitalization and improves lung function and quality of life in patients with COPD[3].

What are the common adverse events associated with Arformoterol Tartrate?

Common adverse events include pain, chest pain, back pain, diarrhea, sinusitis, and leg cramps. Cardiovascular adverse events are also a consideration, although they were not significantly higher than in the placebo group[1].

Which segment is expected to dominate the Arformoterol market?

The inhalation solution segment is expected to account for the largest share of the global Arformoterol market due to its effectiveness and preference in COPD management[5].

What is the projected growth rate of the Arformoterol Tartrate API market?

The market is expected to grow at a remarkable CAGR from 2023 to 2030, driven by increasing demand and favorable market dynamics[2].

Who are the key players in the Arformoterol Tartrate API market?

Key players include INKE SA, GLENMARK LIFE SCIENCES LTD, MSN LABORATORIES PRIVATE LTD, and CIPLA LTD[2].

Sources

  1. Drugs.com: Arformoterol Inhalation Solution: Package Insert / Prescribing Info.
  2. Verified Market Reports: Arformoterol Tartrate API Market Size, Share, Growth.
  3. PubMed: One-year safety and efficacy study of arformoterol tartrate in patients with COPD.
  4. FDA: BROVANA (arformoterol tartrate) Inhalation Solution.
  5. Cognitive Market Research: Global Arformoterol Market Report 2024 Edition.

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