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Last Updated: June 20, 2025

CLINICAL TRIALS PROFILE FOR ADVAIR HFA


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All Clinical Trials for Advair Hfa

Trial ID Title Status Sponsor Phase Start Date Summary
NCT00102882 ↗ Study Of Asthma And Genetics In Patients To Be Treated With Fluticasone Propionate/Salmeterol Or Salmeterol Xinafoate Completed GlaxoSmithKline Phase 4 2004-10-01 This study may last up to 36-38 weeks. Patients will visit the clinic 11 times. A blood sample will be taken at Visit 1 to look at subjects' genes. Breathing tests will be done during the study. Study medicines and procedures will be provided at no cost. Patients will be treated with VENTOLIN (8 wks), ATROVENT (8 wks), then ADVAIR or SEREVENT (16 wks). ADVAIR and SEREVENT are FDA approved for the treatment of asthma in patients 4 years of age and older.
NCT00115492 ↗ Advair® DISKUS® Versus Serevent® DISKUS® For Chronic Obstructive Pulmonary Disease Exacerbations Completed GlaxoSmithKline Phase 4 2004-12-01 This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by FDA for use in patients with COPD.
NCT00120978 ↗ Can Advair and Flovent Reduce Systemic Inflammation Related to Chronic Obstructive Pulmonary Disease (COPD)? A Multi-Center Randomized Controlled Trial Unknown status GlaxoSmithKline Phase 4 2004-12-01 Large population-based studies suggest that patients with chronic obstructive pulmonary disease (COPD) are 2 to 3 times at risk for cardiovascular mortality, which accounts for a large proportion of the total number of deaths. How COPD increases the risk of poor cardiovascular outcomes is largely unknown. However, there is growing evidence that persistent low-grade systemic inflammation is present in COPD and that this may contribute to the pathogenesis of atherosclerosis and cardiovascular disease among COPD patients. Inflammation and more specifically, C-reactive protein (CRP), has been linked with all stages of atherosclerosis, including plaque genesis, rupture and subsequent thrombo-fibrosis of vulnerable vessels. Recently, our group has demonstrated in a relatively small study that short-term inhaled corticosteroid (ICS) therapy can repress serum CRP levels in stable COPD patients. Conversely, withdrawal of ICS leads to a marked increase in serum CRP levels. Although very promising, these data cannot be considered definitive because the study was small in size and scope (N=41 patients). Additionally, this study did not address the potential effects of combination therapy with ICS and long-acting β2 agonists (LABA). This is an important short-coming because combination therapy of ICS and LABA have been shown to produce improved clinical outcomes over ICS monotherapy and is commonly used by clinicians in the treatment of moderate to severe COPD. We hypothesize that inhaled fluticasone (Flovent®) reduces systemic inflammation and that combination therapy (Advair®) is more effective than steroids alone in reducing systemic inflammation in COPD. In this proposal, we will implement a randomized controlled trial to determine whether ICS by themselves or in combination with LABAs can: 1. reduce CRP levels in stable COPD patients and 2. reduce other pro-inflammatory cytokines, which have been linked with cardiovascular morbidity and mortality such as interleukin-6 (IL-6) and monocyte chemoattractant protein-1 (MCP-1)
NCT00120978 ↗ Can Advair and Flovent Reduce Systemic Inflammation Related to Chronic Obstructive Pulmonary Disease (COPD)? A Multi-Center Randomized Controlled Trial Unknown status University of British Columbia Phase 4 2004-12-01 Large population-based studies suggest that patients with chronic obstructive pulmonary disease (COPD) are 2 to 3 times at risk for cardiovascular mortality, which accounts for a large proportion of the total number of deaths. How COPD increases the risk of poor cardiovascular outcomes is largely unknown. However, there is growing evidence that persistent low-grade systemic inflammation is present in COPD and that this may contribute to the pathogenesis of atherosclerosis and cardiovascular disease among COPD patients. Inflammation and more specifically, C-reactive protein (CRP), has been linked with all stages of atherosclerosis, including plaque genesis, rupture and subsequent thrombo-fibrosis of vulnerable vessels. Recently, our group has demonstrated in a relatively small study that short-term inhaled corticosteroid (ICS) therapy can repress serum CRP levels in stable COPD patients. Conversely, withdrawal of ICS leads to a marked increase in serum CRP levels. Although very promising, these data cannot be considered definitive because the study was small in size and scope (N=41 patients). Additionally, this study did not address the potential effects of combination therapy with ICS and long-acting β2 agonists (LABA). This is an important short-coming because combination therapy of ICS and LABA have been shown to produce improved clinical outcomes over ICS monotherapy and is commonly used by clinicians in the treatment of moderate to severe COPD. We hypothesize that inhaled fluticasone (Flovent®) reduces systemic inflammation and that combination therapy (Advair®) is more effective than steroids alone in reducing systemic inflammation in COPD. In this proposal, we will implement a randomized controlled trial to determine whether ICS by themselves or in combination with LABAs can: 1. reduce CRP levels in stable COPD patients and 2. reduce other pro-inflammatory cytokines, which have been linked with cardiovascular morbidity and mortality such as interleukin-6 (IL-6) and monocyte chemoattractant protein-1 (MCP-1)
NCT00144911 ↗ ADVAIR® DISKUS® Inhaler (Fluticasone Propionate/Salmeterol) Versus SEREVENT® DISKUS® Inhaler (Salmeterol) For The Treatment Of Chronic Obstructive Pulmonary Disease Exacerbations. ADVAIR® DISKUS® Inhaler and SEREVENT® DISKUS® Inhaler Are Tra Completed GlaxoSmithKline Phase 4 2004-10-01 This study evaluates the effect of two medicines on COPD (Chronic Obstructive Pulmonary Disease) exacerbations. This study will last up to 56 weeks, and subjects will visit the clinic 10 times. Subjects will be given breathing tests and will record their breathing symptoms daily on diary cards. All study related medicines and medical examinations will be provided at no cost. The two drugs used in this study have been approved by the FDA for use in patients with COPD.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for Advair Hfa

Condition Name

Condition Name for Advair Hfa
Intervention Trials
Asthma 52
Bioequivalence 10
Pulmonary Disease, Chronic Obstructive 9
Chronic Obstructive Pulmonary Disease 8
[disabled in preview] 0
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Condition MeSH

Condition MeSH for Advair Hfa
Intervention Trials
Asthma 48
Pulmonary Disease, Chronic Obstructive 20
Lung Diseases 20
Lung Diseases, Obstructive 18
[disabled in preview] 0
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Clinical Trial Locations for Advair Hfa

Trials by Country

Trials by Country for Advair Hfa
Location Trials
United States 699
Canada 46
Germany 23
Argentina 23
United Kingdom 17
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Trials by US State

Trials by US State for Advair Hfa
Location Trials
Florida 29
California 29
North Carolina 28
Texas 27
Colorado 25
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Clinical Trial Progress for Advair Hfa

Clinical Trial Phase

Clinical Trial Phase for Advair Hfa
Clinical Trial Phase Trials
Phase 4 35
Phase 3 17
Phase 2 6
[disabled in preview] 15
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Clinical Trial Status

Clinical Trial Status for Advair Hfa
Clinical Trial Phase Trials
Completed 63
Terminated 5
Unknown status 5
[disabled in preview] 7
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Clinical Trial Sponsors for Advair Hfa

Sponsor Name

Sponsor Name for Advair Hfa
Sponsor Trials
GlaxoSmithKline 33
Respirent Pharmaceuticals Co Ltd. 12
Becro Ltd. 11
[disabled in preview] 12
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Sponsor Type

Sponsor Type for Advair Hfa
Sponsor Trials
Industry 97
Other 32
NIH 4
[disabled in preview] 1
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Advair HFA: Clinical Trials, Market Analysis, and Projections

Introduction

Advair HFA, a combination inhaler containing salmeterol and fluticasone propionate, is a widely used medication for the treatment of asthma and chronic obstructive pulmonary disease (COPD). Here, we will delve into the current clinical trials, market analysis, and future projections for this drug.

Clinical Trials Update

Current Studies

Two significant studies are currently underway to evaluate the safety and efficacy of Advair HFA:

Phase 1/2a Study

This study focuses on the safety of high-dose salmeterol/fluticasone (Advair HFA) versus placebo in healthy individuals exercising under hypoxic, simulated high-altitude conditions. The study also aims to assess the drug's efficacy in improving exercise performance under these conditions[1].

Phase 2a Study

This double-blinded, placebo-controlled, randomized crossover study examines the efficacy and safety of salmeterol/fluticasone in both healthy (HAPE-resistant) and HAPE-susceptible individuals. The study involves dosing subjects with salmeterol/fluticasone 126mcg/270mcg twice daily for two days before hypoxic exercise testing. Key efficacy assessments include VO2 max, right heart catheter measurements, PaO2, A-a gradients, and blood lactate levels[1].

Blinding and Design

Both studies are designed with investigators and subjects blinded to the assignment group, ensuring unbiased results.

Market Analysis

Global Asthma and COPD Therapeutics Market

The global market for asthma and COPD therapeutics is projected to reach $44.1 billion by 2031, growing at a CAGR of 7.3% over the forecast period. However, Advair HFA is facing significant challenges within this market[2].

Decline of Advair HFA

Advair HFA has lost substantial market share due to several factors:

  • Negative Publicity: Concerns over death risks associated with the administration of the drug have negatively impacted its reputation.
  • Reduced Reimbursement: Decreased reimbursement levels in the U.S. have further reduced its sales.
  • Patent Expiry: The expiry of both the drug and device patents has opened the market to generic competitors and new entrants.
  • New Market Entrants: Drugs like GSK’s Breo Ellipta and Incruse Ellipta, as well as Boehringer’s Stiolto Respimat, are gaining market share, intensifying competition[2][3].

Competitive Landscape

The asthma and COPD therapeutics market is highly competitive, with several other drugs showing positive growth trends:

  • Breo Ellipta: Expected to experience sales growth, posing a significant threat to Advair HFA.
  • Incruse Ellipta and Stiolto Respimat: New entrants with patent expiry dates in the near future, likely to capture more market share.
  • Spiriva: Remains a major player in the COPD market, further fragmenting the market share of Advair HFA[2][3].

Projections and Future Outlook

Market Share and Sales

Given the current trends, Advair HFA's sales are projected to decline further. The introduction of new drugs and the expiry of its patents will continue to erode its market share. New products like Nucala and Breo Ellipta are poised to capture a larger share of the market[2].

Regulatory and Environmental Considerations

The use of hydrofluoroalkane (HFA) propellants in Advair HFA, while environmentally more friendly than the previous chlorofluorocarbons (CFCs), still contributes to greenhouse gas emissions. However, HFA MDIs are expected to remain relevant due to their suitability for certain patients and specific medical needs[5].

Patient Preferences and Needs

Despite the decline in market share, Advair HFA may still be preferred by some patients due to its established efficacy and patient familiarity. However, the increasing availability of alternative treatments will continue to influence patient choices and prescribing practices[5].

Geriatric Considerations and Pharmacokinetics

Geriatric Use

Clinical trials of Advair HFA did not include sufficient numbers of subjects aged ≥65 years to determine whether older subjects respond differently. Therefore, dose selection for elderly patients should be cautious, starting at the lower end of the dosing range due to potential decreased hepatic, renal, or cardiac function[4].

Pharmacokinetics

  • Fluticasone Propionate: High lipid solubility and tissue binding, with a volume of distribution averaging 4.2 L/kg and 99% bound to human plasma proteins.
  • Salmeterol: Highly protein-bound (>96%) with a long elimination half-life of its xinafoate moiety (11 days)[4].

Adverse Reactions and Interactions

Common Adverse Reactions

Advair HFA is associated with several adverse reactions, including upper respiratory tract infection, throat irritation, dysphonia, headache, dizziness, nausea, vomiting, oral candidiasis, pneumonia, and hypersensitivity reactions[4].

Interactions

Special caution is advised when using Advair HFA with certain medications, such as beta-depleting diuretics, due to potential interactions[4].

Key Takeaways

  • Advair HFA is undergoing clinical trials to evaluate its safety and efficacy in specific conditions, including high-altitude exercise and HAPE susceptibility.
  • The drug faces significant market challenges due to negative publicity, reduced reimbursement, patent expiry, and new market entrants.
  • The global asthma and COPD therapeutics market is growing, but Advair HFA's share is declining.
  • Geriatric patients require cautious dose selection due to potential decreased organ function.
  • The drug has specific pharmacokinetic properties and potential adverse reactions that need careful management.

FAQs

Q: What are the current clinical trials focusing on for Advair HFA?

A: The current trials are evaluating the safety and efficacy of high-dose salmeterol/fluticasone in healthy individuals under hypoxic conditions and its potential to prevent pulmonary edema and enhance exercise capacity in HAPE-susceptible individuals.

Q: Why is Advair HFA losing market share?

A: Advair HFA is losing market share due to negative publicity about death risks, reduced reimbursement in the U.S., patent expiry, and the introduction of new market entrants.

Q: What are some of the new drugs competing with Advair HFA?

A: New drugs like Breo Ellipta, Incruse Ellipta, and Stiolto Respimat are gaining market share and competing with Advair HFA.

Q: How does the use of HFA propellants in Advair HFA impact the environment?

A: While HFA propellants are more environmentally friendly than CFCs, they still contribute to greenhouse gas emissions. However, they remain necessary for certain medical needs.

Q: What special considerations are needed when prescribing Advair HFA to geriatric patients?

A: Geriatric patients require cautious dose selection, starting at the lower end of the dosing range, due to potential decreased hepatic, renal, or cardiac function.

Sources

  1. CenterWatch: Advair HFA in Healthy and HAPE Predisposed Subjects | Clinical Trials.
  2. iHealthcareAnalyst: Global Asthma and COPD Therapeutics Market $44.1 Billion by 2031.
  3. iHealthcareAnalyst: Asthma and COPD Therapeutics Market and Forecast 2024-2031.
  4. eMPR: ADVAIR HFA Prescription & Dosage Information.
  5. EPA: Market Characterization of the U.S. Metered Dose Inhaler Industry.
Last updated: 2024-12-31

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