CLINICAL TRIALS PROFILE FOR ATROVENT

505(b)(2) Clinical Trials for ATROVENT

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

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

Condition Name

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

Condition MeSH

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

Clinical Trial Locations for ATROVENT

Trials by Country

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

Trials by US State

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

Clinical Trial Progress for ATROVENT

Clinical Trial Phase

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

Clinical Trial Status

Clinical Trial Status for ATROVENT
Clinical Trial Phase	Trials
Completed	39
Unknown status	4
Not yet recruiting	2

Clinical Trial Sponsors for ATROVENT

Sponsor Name

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

Sponsor Type

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

Atrovent (Ipratropium bromide): Clinical Trials Update and Market Projection

Last updated: April 24, 2026

What is Atrovent and what products drive the market?

Atrovent is the brand name for ipratropium bromide, an inhaled anticholinergic used to treat chronic obstructive pulmonary disease (COPD) and recurrent airway obstruction in asthma. The market has historically been anchored by short-acting inhaled formulations (notably nebulized and metered-dose inhaler presentations), with performance competed against other anticholinergics and combination respiratory regimens.

Key branded reference points:

• ATROVENT (ipratropium bromide) is marketed in multiple forms, including inhalation solution (nebulizer) and inhaler presentations (strengths and country-specific labeling vary).
• Over time, uptake has been pressured by LAMA and LAMA/LABA regimens (e.g., tiotropium, aclidinium, umeclidinium and combinations), which typically provide longer dosing intervals and stronger guideline positioning for COPD maintenance.

What is the current clinical trials footprint for ipratropium bromide (Atrovent)?

A complete, date-stamped global clinical trials update for “Atrovent” depends on how trials are indexed (brand name vs. active ingredient). Across public registries, the dominant pattern for ipratropium bromide in 2022 to 2025 is:

• Fewer brand-labeled trials versus earlier decades
• More activity in formulation, bioequivalence, pediatric/real-world outcomes, and regulatory updates rather than large, late-stage COPD endpoints
• Continued presence in combination and comparative effectiveness studies, often using active ingredient search terms rather than “Atrovent”

Because a brand-name-only query misses trials filed under “ipratropium bromide,” market and pipeline surveillance is best conducted at the active ingredient level. In practice, this yields ongoing but fragmented trial signals rather than a single dominant “Atrovent pipeline” narrative.

What do the latest public trial signals indicate about development direction?

Across registry-style datasets, the ongoing development themes for ipratropium bromide cluster into four buckets:

1. Respiratory control in COPD and acute settings
   • Studies that compare short-acting anticholinergic effects in exacerbation management and symptom control patterns.
2. Asthma and airflow obstruction phenotypes
   • Trials that evaluate ipratropium as an add-on or for specific patient phenotypes where inhaled bronchodilation is measured.
3. Device and formulation equivalence
   • Studies that validate inhalation delivery characteristics and interchangeability across regions and generics.
4. Special populations
   • Pediatric-adjacent research and subgroup analysis in chronic respiratory disease cohorts.

These themes align with a drug that is mature and widely available as generics, where new development often targets incremental clinical or regulatory value rather than new molecular breakthroughs.

What does the commercial landscape look like for Atrovent?

Atrovent is in a structurally challenging segment:

• Short-acting anticholinergic class positioning in COPD versus long-acting alternatives.
• Mature patent regime and broad generic penetration in many geographies.
• Pricing and volume dynamics driven by formularies, guideline adherence, and switching behavior among prescribers to LAMA or combination therapies.

Competitive set (functional substitutes)

• LAMA monotherapy (long-acting muscarinic antagonists)
• LAMA/LABA and triple therapy (LAMA/LABA/ICS) in COPD
• Other short-acting agents used in acute symptom relief contexts

In COPD maintenance, the incremental clinical value typically favors long-acting anticholinergics, which is a direct headwind for Atrovent’s long-term share retention in adult chronic therapy markets.

How does geography affect market strength?

Atrovent market dynamics split along these lines:

• Developed markets: generic availability and LAMA displacement suppress branded growth; market value concentrates in steady demand for short-acting rescue/adjunct use.
• Emerging markets: pricing pressure still applies, but access constraints can preserve broader use of older respiratory regimens in certain systems; local tender and reimbursement structures materially influence utilization.

Market sizing logic: what can be projected for Atrovent?

For a mature, widely generified inhaled anticholinergic like ipratropium bromide, a practical market projection framework uses:

• Unit demand anchored to COPD/asthma treated populations using short-acting rescue or adjunct bronchodilators
• Share of use relative to LAMA/LABA adoption by guideline and payer tiering
• Pricing drift from generic competition and local reimbursement
• Formulation mix changes (nebulizer vs. inhaler)
• Exacerbation seasonality effects, where acute add-on usage increases short-acting volume

Scenario projections (directional)

Given class trends and generic saturation:

• Base case: flat to low-single-digit global value growth with volume stability or slow decline, driven by substitution to long-acting anticholinergics.
• Downside: sharper share erosion as guidelines and payer formularies increase LAMA and triple therapy access.
• Upside: sustained regional demand where nebulized short-acting regimens stay entrenched in primary care or acute care pathways, plus potential device renewal in specific markets.

What is the most investable signal for Atrovent-like products?

For an ipratropium bromide ecosystem, the investable signals shift from molecule-based breakthroughs to:

• Device-related differentiation that improves adherence and delivery performance in real use
• Regulatory upgrades that support product lifecycle management in jurisdictions with slower substitution
• Formulation and combination strategy around standard-of-care regimens where short-acting bronchodilation still plays a role
• Tender and payer contracting in hospitals and respiratory clinics

Clinical outcomes: how does ipratropium bromide generally perform versus newer anticholinergics?

In COPD and asthma symptom control, ipratropium bromide has an established pharmacology and clinical role for short-acting bronchodilation. However, relative effectiveness and convenience typically favor long-acting agents for maintenance. The clinical differentiation narrows to:

• Rescue/adjunct use needs
• Patient-specific tolerance and device fit
• Settings where LAMA initiation is limited by access, physician preference, or formulary design

What are the key risks to the Atrovent market outlook?

1. Sustained guideline-based switching to long-acting anticholinergics and fixed-dose combinations
2. Generic pricing compression and tender dynamics
3. Device substitution that changes hospital and outpatient inhalation workflows
4. Therapy modernization that reduces the share of short-acting anticholinergic use in chronic management

What are the key upside drivers?

1. Acute-care and exacerbation workflow that uses nebulized short-acting bronchodilation at scale
2. Regional reimbursement inertia where older regimens remain reimbursed longer than molecular substitutes
3. Adherence-specific use cases where dosing and device capabilities match patient needs

What is the projection range for Atrovent through the mid-term?

A defensible projection for Atrovent’s global market value should be expressed as a range due to mature competition and the predominance of regional tender/pricing effects rather than a single global launch dynamic. The directional outlook is:

• Global branded value: declining to stable at best, with branded sales tracking generic absorption and portfolio rebalancing.
• Total ipratropium bromide category value: flat to modest growth, driven by population base and acute-care utilization, offset by substitution to long-acting anticholinergic regimens.

What should drug developers and investors watch next?

The near-term watchlist for ipratropium bromide/Atrovent positioned programs:

• Registry updates for new inhalation device systems and bioequivalence/regulatory studies under ipratropium bromide
• Comparative studies that quantify how often short-acting anticholinergics still get used in real-world COPD rescue and adjunct care
• Region-specific changes in formulary access that shift usage between nebulized short-acting regimens and long-acting maintenance therapy

Key Takeaways

• Atrovent (ipratropium bromide) is a mature, widely generified short-acting anticholinergic facing structural share pressure from LAMA and combination COPD therapies.
• Public clinical activity is expected to center on incremental regulatory, formulation, and real-world signals rather than major late-stage COPD breakthroughs.
• Market value outlook is flat to low-growth at the category level, with branded performance typically constrained by generic penetration and guideline-driven switching.
• The most meaningful forward indicators are device and delivery updates, region-specific reimbursement, and acute-care utilization patterns.

FAQs

1) Does Atrovent have a meaningful late-stage COPD pipeline in the current cycle?
Clinical trial signals for ipratropium bromide are generally dominated by incremental/regulatory studies rather than blockbuster late-stage COPD endpoint programs, consistent with a mature, generified molecule.

2) Will LAMA and triple therapy keep reducing Atrovent use?
Yes. COPD maintenance care increasingly prioritizes long-acting bronchodilation and fixed combinations, which reduces routine reliance on short-acting anticholinergics.

3) Where does Atrovent still fit clinically?
Atrovent retains a role in short-acting bronchodilation for symptom relief and certain adjunct or acute-care workflows, particularly where nebulized delivery is used.

4) What drives revenue more for ipratropium bromide: volume or price?
Both matter, but mature generics typically make revenue more sensitive to price and tender/regional contracting than to new demand expansion.

5) What is the best “signal” to track for near-term market movement?
Track formulary and device workflow changes that determine how often clinicians still use nebulized/short-acting anticholinergic regimens in COPD and exacerbation pathways.

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References (APA)

[1] FDA. (n.d.). Atrovent (ipratropium bromide) prescribing information. U.S. Food and Drug Administration.
[2] Global Initiative for Chronic Obstructive Lung Disease (GOLD). (2024). 2024 report. GOLD.
[3] ClinicalTrials.gov. (n.d.). Ipratropium bromide (search results). U.S. National Library of Medicine.
[4] EMA. (n.d.). Atrovent (ipratropium bromide) assessment documents and product information. European Medicines Agency.