CLINICAL TRIALS PROFILE FOR ATROVENT HFA

505(b)(2) Clinical Trials for ATROVENT HFA

This table shows clinical trials for potential 505(b)(2) applications. See the next table for all clinical trials

Trial Type	Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	Simbec Research	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.
New Combination	NCT03906045 ↗	A Scintigraphy Study of PT010 in COPD Patients	Completed	AstraZeneca	Phase 1	2019-04-04	This study is a single treatment period, single dose gamma scintigraphy study investigating the deposition in the lungs of a Budesonide, Glycopyrronium and Formoterol Fumarate Metered Dose Inhaler (BGF-MDI). This study will be investigating how the drug (known as PT010) is distributed in the lungs of Chronic Obstructive Pulmonary Disease (COPD) patients (with moderate to very severe COPD) following a maximal 10 second breath hold. This inhaler is intended to be used in the treatment of COPD, which is a group of diseases which cause lung problems and difficulty breathing. PT010 is a new combination product of 3 marketed drugs called Glycopyrronium, Formoterol Fumarate and Budesonide.

All Clinical Trials for ATROVENT 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.
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)
NCT00180843 ↗	Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease	Terminated	GlaxoSmithKline	N/A	2005-09-01	Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.
NCT00180843 ↗	Assessment of Ventilation-perfusion Abnormalities in Patients With Stable Smoking-related Airways Disease	Terminated	Imperial College London	N/A	2005-09-01	Subjects undergo history, examination, lung function assessment after informed consent has been obtained. All subjects will undergo ventilation-perfusion scans. If there first scan is normal they will undergo a second and final scan four weeks later. If abnormal they will undergo two further scans with either nebulized bronchodilator or nebulized saline prior to their second and third scans. Each time they will have repeat lung function tests prior to scanning. We will examine the regional changes in ventilation and perfusion and there relationship to lung function.
NCT00202176 ↗	Effects of Bronchodilators in Mild Chronic Obstructive Pulmonary Disease (COPD)	Completed	Queen's University	Phase 4	2005-07-01	In people with mild COPD, the ability to exhale air from the lungs is partly limited because of narrowing and collapse of the airways. This results in the trapping of air within the lungs and over-distention of the lungs and chest (lung hyperinflation). Breathing at high lung volumes (hyperinflation) is an important cause of breathing discomfort (dyspnea) in people with COPD. Bronchodilators help to relax muscles in the airways or breathing tubes. Bronchodilators are often prescribed if a cough occurs with airway narrowing as this medication can reduce coughing, wheezing and shortness of breath. Bronchodilators can be taken orally, through injection or through inhalation and begin to act almost immediately but with the effect only lasting 4-6 hours. The main purpose of this study is to examine the effects of inhaled bronchodilators on breathing discomfort and exercise endurance in patients with mild COPD.
NCT00239421 ↗	A Six-week Study Comparing the Efficacy and Safety of Tiotropium Plus Formoterol to Salmeterol Plus Fluticasone in Chronic Obstructive Pulmonary Disease (COPD)	Completed	Boehringer Ingelheim	Phase 4	2003-11-01	To compare the efficacy and safety of tiotropium plus formoterol in comparison to salmeterol plus fluticasone in COPD patients.

Clinical Trial Conditions for ATROVENT HFA

Condition Name

Condition Name for ATROVENT HFA
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	20
Asthma	9
Chronic Obstructive Pulmonary Disease	5
COPD	4

Condition MeSH

Condition MeSH for ATROVENT HFA
Intervention	Trials
Pulmonary Disease, Chronic Obstructive	30
Lung Diseases	28
Lung Diseases, Obstructive	26
Chronic Disease	20

Clinical Trial Locations for ATROVENT HFA

Trials by Country

Trials by Country for ATROVENT HFA
Location	Trials
United States	104
China	16
Canada	8
United Kingdom	3
Peru	2

Trials by US State

Trials by US State for ATROVENT HFA
Location	Trials
New York	6
California	5
North Carolina	5
New Jersey	5
Florida	4

Clinical Trial Progress for ATROVENT HFA

Clinical Trial Phase

Clinical Trial Phase for ATROVENT HFA
Clinical Trial Phase	Trials
Phase 4	13
Phase 3	12
Phase 2	5

Clinical Trial Status

Clinical Trial Status for ATROVENT HFA
Clinical Trial Phase	Trials
Completed	39
Unknown status	4
Terminated	2

Clinical Trial Sponsors for ATROVENT HFA

Sponsor Name

Sponsor Name for ATROVENT HFA
Sponsor	Trials
Boehringer Ingelheim	22
GlaxoSmithKline	5
AstraZeneca	3

Sponsor Type

Sponsor Type for ATROVENT HFA
Sponsor	Trials
Industry	35
Other	28
NIH	1

ATROVENT HFA Market Analysis and Financial Projection

Last updated: May 3, 2026

Clinical Trials Update, Market Analysis, and Projection for ATROVENT HFA (ipratropium bromide inhalation aerosol)

What is ATROVENT HFA and what clinical evidence is driving its market position?

ATROVENT HFA is an inhaled, short-acting muscarinic antagonist (SAMA) containing ipratropium bromide as an aerosol for chronic obstructive pulmonary disease (COPD) and as-needed bronchodilation. It is positioned for symptomatic relief and is used across multiple care settings where maintenance therapy is paired with rescue bronchodilation.

Because ATROVENT HFA is an established, off-patent respiratory product, the core commercial value is tied to:

• Formulary access and inhaler utilization within COPD treatment patterns.
• Competitive differentiation versus other short-acting bronchodilators (SABAs and SAMAs) and fixed-dose combination inhalers.
• Manufacturing and supply continuity, since the product competes in a crowded respiratory inhaler portfolio.

Regulatory and product identity anchors

• Drug: ipratropium bromide inhalation aerosol.
• Brand: ATROVENT HFA.
• Indication (US label): COPD-associated bronchospasm (maintenance and/or symptomatic relief in line with approved labeling).
  Source: U.S. FDA label database entry for ATROVENT HFA (ipratropium bromide) (accessed via FDA labeling system). [1]

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What clinical trials update matters for a product like ATROVENT HFA?

For established inhalers, “clinical trials updates” in practice translate into three categories of evidence that can affect uptake even without new blockbuster efficacy trials:

1. Labeling refinements and safety signal management
2. Bioequivalence and formulation/device consistency
3. Comparative effectiveness evidence in real-world prescribing

For ATROVENT HFA specifically, the most market-relevant items in the public domain are label maintenance, device consistency, and ongoing postmarketing pharmacovigilance rather than late-stage efficacy pivotal trials.

Where the latest public clinical-trials cadence typically shows up

• Postmarketing requirements and pharmacovigilance
• Studies tied to formulation equivalence (including inhaler performance consistency)
• Comparative utilization studies in COPD treatment algorithms

No late-stage phase 3 or new molecular entity trial results are a primary driver for this category. The product’s competitive position is instead reinforced through guideline-concordant placement and formulary retention.

Sources: FDA labeling record for ATROVENT HFA; FDA Orange Book listing for formulation and regulatory status (where applicable). [1][2]

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How is the COPD inhaler market structured, and where does ATROVENT HFA fit?

What does the competitive landscape look like?

COPD inhaler therapy has shifted over time toward long-acting bronchodilators (LAMA and LABA) and fixed triple combinations (LAMA/LABA/ICS). Within that environment, ATROVENT HFA competes primarily as a short-acting SAMA option and as part of combination rescue or stepped-care regimens.

Key competitive segments that influence share and pricing power:

• Short-acting bronchodilators for rescue
  • SABA (for acute symptom relief)
  • SAMA (including ipratropium products)
• Long-acting bronchodilators
  • LAMA (e.g., tiotropium-class products)
  • LABA and LABA/LAMA combos
• Fixed triple therapy
  • LAMA/LABA/ICS (drives a large share of managed care spend)

ATROVENT HFA’s role is typically adjunctive rather than the core controller therapy for most moderate-to-severe COPD patients.

Sources: FDA and guideline-linked COPD therapeutic framework (clinical practice and product labeling context). [1]

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What is the market pull-through mechanism for ATROVENT HFA?

For short-acting inhalers, demand is influenced by:

• Treatment pattern adherence: patients using rescue inhalers and those who cannot tolerate certain alternatives.
• Health plan incentives: formulary placement for rescue products.
• Switching costs and device preferences: inhaler technique and patient familiarity.
• Generic competition risk: class and ingredient overlap can pressure pricing where equivalents exist.

The market outcome for ATROVENT HFA typically depends less on new trials and more on:

• Contract pricing and distribution coverage,
• Managed-care formulary status,
• and generic/biosimilar-like substitution dynamics (where legally applicable).

Sources: FDA labeling record and regulatory status systems for ipratropium aerosol products in US. [1][2]

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Market projection for ATROVENT HFA: revenue and demand outlook

What drives near-term growth versus decline?

Near-term outcomes for an established SAMA aerosol are usually dominated by:

• Volume stability: rescue use is persistent but not expanding as controller therapy intensifies.
• Price compression: increased payer pressure and competitive substitution.
• Utilization shifts: COPD management moves toward long-acting regimens; rescue use frequency may remain stable but total inhaler counts can change based on regimen adjustments.

Without introducing new late-stage efficacy evidence, the most plausible direction for the brand is:

• Moderate volume stability (rescue-driven)
• Downward pricing pressure (managed care and substitution)
• Net revenue growth limited unless contract terms improve or supply is constrained elsewhere in the class

How should investors model the next 3 to 5 years?

A practical projection framework for ATROVENT HFA should model:

• COGS and distribution stability (resilience is common in mature inhaler categories)
• Share pressure from class substitution (SAMA alternatives or broader controller uptake reducing rescue intensity)
• Net revenue based on payer mix and contract pricing, not on disease incidence alone

Projection ranges (directional model)

Because the product is mature and off-patent for most practical purposes, projections should focus on rate drivers rather than assuming market expansion from clinical breakthroughs.

3-year and 5-year outlook (directional)

• Volume: low to mid single-digit annual change, typically flat to slightly down as controller regimens reduce reliance on rescue inhalers.
• Price: negative drift from payer pressure and substitution, with intermittent rebound only under supply constraints or favorable contracts.
• Revenue: likely low single-digit decline annually unless pricing stabilizes via contract renegotiation.

Scenario table for planning purposes (directional) | Scenario | Volume trend | Net price trend | Revenue trend | |---|---:|---:|---:| | Base case | Flat to -1%/yr | -2% to -3%/yr | -2% to -4%/yr | | Downside | -2% to -3%/yr | -3% to -4%/yr | -5% to -8%/yr | | Upside | +0% to +1%/yr | -1% to -2%/yr | -1% to +1%/yr |

This modeling structure reflects typical mature inhaler economics in a COPD market dominated by long-acting therapies.

Sources: FDA label and regulatory structure for ipratropium aerosol; general US respiratory market structure inferred from FDA labeling and product category positioning. [1]

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Operational risks and watch items that affect market outcomes

What are the key risks to ATROVENT HFA demand and pricing?

1. Formulary substitution within COPD rescue classes
   • Payers can prefer alternative rescue agents and lower-cost equivalents.
2. Shift toward long-acting controller regimens
   • As LAMA/LABA or triple therapy expands, rescue usage can become less frequent per patient.
3. Device and supply disruptions
   • Mature inhalers can be exposed to manufacturing constraints; supply shocks can temporarily boost market share but can also generate backorders and loss of formulary confidence.
4. Regulatory labeling maintenance cycles
   • Any safety updates can affect prescriber and payer comfort, changing utilization.

Sources: FDA labeling record for ATROVENT HFA; FDA labeling and regulatory status frameworks. [1][2]

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Key Takeaways

• ATROVENT HFA is a mature, short-acting ipratropium bromide inhalation aerosol positioned for COPD bronchospasm and symptomatic relief. [1]
• Clinical “updates” that drive market outcomes for mature inhalers are typically label maintenance, postmarketing safety, and formulation/device consistency, not new phase 3 efficacy breakthroughs. [1]
• Market performance is dominated by payer contracting, formulary retention, and substitution pressure from broader COPD inhaler classes and lower-cost options.
• A base-case market model supports flat-to-slightly declining volume, continued pricing pressure, and low-to-mid single-digit annual revenue decline, unless contracts or supply conditions improve.

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FAQs

1) Is ATROVENT HFA a controller or rescue inhaler?

ATROVENT HFA is used for symptomatic relief/bronchodilation in COPD, functioning as a short-acting option rather than a long-acting controller. [1]

2) What patient segment is most associated with ATROVENT HFA use?

Patients who require short-acting bronchodilation for COPD symptoms, often alongside long-acting regimens. [1]

3) What is the main competitive pressure on ATROVENT HFA?

Substitution within COPD inhalation therapy patterns, particularly payer-optimized access to alternative short-acting bronchodilators and the broader shift toward long-acting controller therapies. [1]

4) Are new clinical trials likely to materially change ATROVENT HFA’s market outlook?

For established products like ATROVENT HFA, material market shifts typically come from regulatory/label updates and contracting/supply dynamics rather than new efficacy pivotal trials. [1]

5) How should revenue projections be structured for ATROVENT HFA?

Model volume stability, contract-driven net price drift, and formulary share pressure, using scenario-based ranges rather than assuming major market expansion from clinical novelty.

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References

[1] U.S. Food and Drug Administration. ATROVENT HFA (ipratropium bromide inhalation aerosol) label and prescribing information. FDA Labeling (accessed 2026-05-03).
[2] U.S. Food and Drug Administration. Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations (ipratropium bromide inhalation aerosol listings). FDA Orange Book (accessed 2026-05-03).