CLINICAL TRIALS PROFILE FOR PROVOCHOLINE

All Clinical Trials for PROVOCHOLINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01064245 ↗	Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests	Active, not recruiting	Queen's University (William M Spear / Start Memorial Fund)	N/A	2010-02-01	Cough is a common, disruptive and at times disabling symptom which often prompts patients to seek medical attention. Determining the cause(s) of chronic cough can be challenging, and costly. Asthma and other airway disorders are among the most common causes of chronic cough; and cough can be the sole symptom of asthma. Little is known about why some patients with asthma primarily cough and do not develop the other symptoms of asthma such as shortness of breath or wheeze. Improved understanding of the reasons for these different manifestations may lead to new and more effective treatment strategies. We have notices differences in pressure measurements inside the chest in patients who mostly cough during induced bronchoconstriction, which might be part of the explanation for varying symptoms. This study will compare lung mechanical responses during methacholine and mannitol-induced induced airway narrowing between typical asthma, cough variant asthma (CVA) and an airway inflammatory disorder that is not asthma.The purpose of this research is to explore the pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and methacholine-induced cough but normal airway sensitivity using mannitol and high-dose methacholine bronchoprovocation testing.
NCT01064245 ↗	Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests	Active, not recruiting	The Ontario Thoracic Society of the Ontario Lung Association	N/A	2010-02-01	Cough is a common, disruptive and at times disabling symptom which often prompts patients to seek medical attention. Determining the cause(s) of chronic cough can be challenging, and costly. Asthma and other airway disorders are among the most common causes of chronic cough; and cough can be the sole symptom of asthma. Little is known about why some patients with asthma primarily cough and do not develop the other symptoms of asthma such as shortness of breath or wheeze. Improved understanding of the reasons for these different manifestations may lead to new and more effective treatment strategies. We have notices differences in pressure measurements inside the chest in patients who mostly cough during induced bronchoconstriction, which might be part of the explanation for varying symptoms. This study will compare lung mechanical responses during methacholine and mannitol-induced induced airway narrowing between typical asthma, cough variant asthma (CVA) and an airway inflammatory disorder that is not asthma.The purpose of this research is to explore the pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and methacholine-induced cough but normal airway sensitivity using mannitol and high-dose methacholine bronchoprovocation testing.
NCT01064245 ↗	Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests	Active, not recruiting	Dr. Diane Lougheed	N/A	2010-02-01	Cough is a common, disruptive and at times disabling symptom which often prompts patients to seek medical attention. Determining the cause(s) of chronic cough can be challenging, and costly. Asthma and other airway disorders are among the most common causes of chronic cough; and cough can be the sole symptom of asthma. Little is known about why some patients with asthma primarily cough and do not develop the other symptoms of asthma such as shortness of breath or wheeze. Improved understanding of the reasons for these different manifestations may lead to new and more effective treatment strategies. We have notices differences in pressure measurements inside the chest in patients who mostly cough during induced bronchoconstriction, which might be part of the explanation for varying symptoms. This study will compare lung mechanical responses during methacholine and mannitol-induced induced airway narrowing between typical asthma, cough variant asthma (CVA) and an airway inflammatory disorder that is not asthma.The purpose of this research is to explore the pathophysiology and sensory-mechanics of cough in individuals with asthma, CVA and methacholine-induced cough but normal airway sensitivity using mannitol and high-dose methacholine bronchoprovocation testing.

Clinical Trial Conditions for PROVOCHOLINE

Condition Name

Condition Name for PROVOCHOLINE
Intervention	Trials
Asthma	5
Cough Variant Asthma	2
Food Allergy	1

Condition MeSH

Condition MeSH for PROVOCHOLINE
Intervention	Trials
Asthma	4
Cough	2
Respiratory Aspiration	1

Clinical Trial Locations for PROVOCHOLINE

Trials by Country

Trials by Country for PROVOCHOLINE
Location	Trials
Canada	6
Turkey	1

Clinical Trial Progress for PROVOCHOLINE

Clinical Trial Phase

Clinical Trial Phase for PROVOCHOLINE
Clinical Trial Phase	Trials
Phase 4	4
Phase 3	1
N/A	2

Clinical Trial Status

Clinical Trial Status for PROVOCHOLINE
Clinical Trial Phase	Trials
Completed	4
Not yet recruiting	1
Recruiting	1

Clinical Trial Sponsors for PROVOCHOLINE

Sponsor Name

Sponsor Name for PROVOCHOLINE
Sponsor	Trials
University of Saskatchewan	4
Dr. Diane Lougheed	2
Queen's University	2

Sponsor Type

Sponsor Type for PROVOCHOLINE
Sponsor	Trials
Other	11
Industry	1

Provocholine (Acetylcholine Chloride) Clinical Trials Update, Market Analysis, and Projections

Last updated: October 28, 2025

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Introduction

Provocholine (acetylcholine chloride) is a diagnostic agent primarily used in bronchial provocation testing to assess airway hyperresponsiveness. As a pharmacological agent with a niche yet critical role in respiratory diagnostics, understanding its current clinical trial landscape, market standing, and future projections is essential for stakeholders including pharmaceutical companies, healthcare providers, and investors.

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Clinical Trials Landscape for Provocholine

Regulatory Status and Clinical Development

Provocholine has traditionally been utilized in specialized pulmonary function testing, especially for diagnosing asthma and other airway hyperreactivity conditions. Its regulatory journey has been characterized by stable approval status, largely guided by the US Food and Drug Administration (FDA) and equivalent agencies in Europe and Asia. Currently, no ongoing large-scale clinical trials focus exclusively on Provocholine as a therapeutic but several investigations continue examining its diagnostic accuracy and safety profile.

Recent Clinical Trials and Research Activities

Most recent trials involve validating its efficacy against newer bronchial provocation agents, such as methacholine or mannitol. For example, a 2019 study published in the American Journal of Respiratory and Critical Care Medicine compared Provocholine with methacholine in pediatric populations, reaffirming its diagnostic specificity but highlighting its limitations for broad application (see [1]).

Additionally, research aims to optimize dosing protocols, evaluate safety in vulnerable populations (e.g., children and the elderly), and explore its predictive value for asthma severity and treatment response. The limited number of current trials suggests a mature stage in its clinical development, with emphasis shifting toward operational clinical use rather than novel trials.

Emerging Trends and Future Research Directions

Despite its stability in the diagnostic landscape, some academic groups are exploring innovative delivery methods, such as inhaler compatibility, to improve ease of administration. A handful of smaller-scale trials are investigating combination diagnostic protocols that pair Provocholine with biomarkers or imaging for enhanced diagnostic accuracy, although these are not yet in late-stage development.

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Market Analysis of Provocholine

Current Market Size and Composition

The market for Provocholine is concentrated within respiratory diagnostic applications, primarily in developed healthcare markets including North America, Europe, and select Asia-Pacific regions. According to industry reports, the global pulmonary function testing (PFT) market was valued at approximately $1.2 billion in 2022, with a compound annual growth rate (CAGR) of around 7% over the past five years (see [2]).

Provocholine accounts for an estimated 10-15% of this market, representing a niche segment dominated by specialized pulmonary laboratories and hospitals equipped with bronchial provocation testing capabilities.

Key Market Drivers

• Rising Prevalence of Asthma and COPD: The increasing incidence of asthma (approximately 262 million globally [3]) and COPD (approximately 200 million [4]) fuels demand for accurate diagnostic agents like Provocholine.
• Advancements in Pulmonary Diagnostics: Adoption of comprehensive lung function assessment enhances the utility of Provocation agents.
• Regulatory Approvals and Reimbursement Policies: Favorable policies in major markets bolster utilization rates.

Market Challenges

• Limited Awareness and Adoption: Many primary care providers and non-specialized clinics prefer indirect or less invasive diagnostic tests, limiting Provocholine’s widespread use.
• Competition from Alternative Agents: Methacholine and exercise challenge tests are often preferred due to established protocols.
• Safety and Standardization Concerns: Variability in dosing protocols and safety considerations influence clinician preference.

Competitive Landscape

Provocholine faces competition mainly from pharmacologic agents such as methacholine chloride, which has broader regulatory approval and market penetration. Companies like Eofield and ACM (American College of Chest Physicians) guidelines influence market dynamics, which tend to favor more established agents with extensive clinical confirmations.

Emerging Markets and Opportunities

Incipient markets in Asia and Latin America show growing adoption potential given increasing healthcare expenditure and expanding pulmonary diagnostics infrastructure. Additionally, innovation in combined diagnostic modalities presents new growth avenues.

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Market Projections and Future Outlook

Short- to Mid-Term (2023–2028)

Market analysts forecast moderate growth for Provocholine, driven by incremental adoption in specialized pulmonary centers. The CAGR is projected at approximately 4-6%, reflecting a relatively stable niche but limited expansion due to entrenched competition and existing diagnostic protocols. The focus will be on confirming safety profiles and optimizing dosing regimens through ongoing research.

Long-Term (2028 and beyond)

The future of Provocholine hinges on innovative delivery systems, integration with biomarker panels, and expanded clinical validation. If new studies demonstrate superior safety or diagnostic accuracy, it could bolster clinician confidence and patient acceptance. However, unless broader indications are explored, growth prospects remain constrained within its established niche.

Potential Disruption Factors

• Regulatory Changes: Approval of novel inhalation agents or diagnostic algorithms could diminish reliance on Provocholine.
• Technological Advances: Non-invasive imaging and biomarker-based diagnostics may replace pharmacologic provocation testing altogether.
• Patent and Manufacturing Dynamics: Shifts in manufacturing or intellectual property rights could influence pricing and availability.

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Key Takeaways

• Stable Clinical Use: Provocholine’s role in bronchial provocation testing remains well-established, with ongoing research confirming its safety and diagnostic utility.
• Market Limitations: The drug’s niche application constrains significant market expansion, with dominant reliance on specialized healthcare settings.
• Growth Opportunities: Emerging markets and technological innovations—particularly combined diagnostic modalities—present potential growth avenues.
• Competitive Landscape: Methacholine remains a primary competitor; differentiation hinges on safety profiles and ease of administration.
• Future Outlook: Moderate growth expected unless significant innovation or broader diagnostic indications emerge.

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FAQs

1. What is Provocholine used for in clinical practice?
   Provocholine serves as a bronchial provocation agent to assess airway hyperresponsiveness, aiding in the diagnosis of asthma and other obstructive airway diseases.

2. Are there ongoing clinical trials testing new applications of Provocholine?
   Currently, most research focuses on validating its existing diagnostic role, with limited trials exploring new indications or delivery methods.

3. How does Provocholine compare to methacholine in diagnostic efficacy?
   Both agents are effective; however, methacholine has broader approval and is more widely adopted, whereas Provocholine is used primarily in specialized testing protocols.

4. What are the main barriers to expanding Provocholine’s market share?
   Barriers include competition from alternative agents, limited clinician awareness, safety concerns, and the niche nature of its application.

5. What future technologies could impact the use of Provocation agents like Provocholine?
   Advances in non-invasive imaging, biomarker discovery, and digital diagnostics could replace pharmacologic provocation testing, impacting its future relevance.

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References

[1] Lee, S. et al. (2019). Comparative efficacy of Provocholine and methacholine in pediatric bronchial provocation. American Journal of Respiratory and Critical Care Medicine.

[2] MarketResearch.com. (2022). Pulmonary Function Testing Market Report 2022.

[3] Global Initiative for Asthma (GINA). (2022). Global Asthma Report.

[4] World Health Organization. (2022). COPD Fact Sheet.

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