CLINICAL TRIALS PROFILE FOR PROVOCHOLINE

All Clinical Trials for PROVOCHOLINE

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT01618929 ↗	Effects of Montelukast in Asthmatic Children With and Without Food Allergy	Completed	Merck Sharp & Dohme Corp.	Phase 4	2013-03-01	- To search the effects of montelukast on the airway inflammation including FEV1%, FEV1%/FVC, the provocholine® (methacoline chloride powder for inhalation) challenge tests, the leukotriene levels in the exhaled breath condensate in asthmatic children with and without food allergy aged 6-18 years old. - To define the patient groups with good response to montelukast and to define the parameters which predict the good response.
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.
NCT01064245 ↗	Physiology of Cough in Asthma: Comparison of Sensory-Mechanical Responses to Mannitol and Methacholine Challenge Tests	Active, not recruiting	Queen's University	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
Children	1
Cough	1

Condition MeSH

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

Clinical Trial Locations for PROVOCHOLINE

Trials by Country

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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: A Comprehensive Overview of Clinical Trials, Market Analysis, and Projections

Introduction

Provocholine, a methacholine chloride solution, is a crucial diagnostic tool in the assessment of airway hyperresponsiveness, a key feature of asthma. Here, we delve into the clinical trials, market analysis, and future projections for this important pharmaceutical product.

Clinical Trials and Regulatory Approval

Provocholine has been FDA-approved since October 31, 1986, for the diagnosis of bronchial airway hyperreactivity in adults and pediatric patients aged 5 years and older who do not have clinically apparent asthma[2][4].

Clinical Use and Safety

The methacholine challenge test, which utilizes Provocholine, is conducted in a controlled environment such as a pulmonary function laboratory or clinic by trained personnel. The test involves administering increasing concentrations of Provocholine via nebulization to assess the patient's airway response. It is crucial to determine baseline FEV1 values to ensure the patient can safely undergo the test. The test can be administered using either the 5-Breath Dosimeter Dosing Method or the 2-Minute Tidal Breathing Dosing Method with doubling or quadrupling stepwise protocols[4].

Safety Considerations

Provocholine can cause severe bronchoconstriction, even at the lowest doses. It is contraindicated in patients with baseline FEV1 < 60% predicted or adults with FEV1 < 1.5 L. Emergency equipment and medication must be readily available to treat acute respiratory distress[1][4].

Market Analysis

Global Clinical Trials Market

The global clinical trials market, which includes the development and testing of drugs like Provocholine, was valued at USD 84.61 billion in 2024 and is projected to reach USD 146.60 billion by 2033, growing at a CAGR of 6.07% during the forecast period (2025–2033). This growth is driven by the increasing prevalence of chronic diseases and government initiatives supporting clinical trials[3].

Specific Market for Diagnostic Drugs

While the broader clinical trials market is expanding, the specific segment for diagnostic drugs like Provocholine is also seeing significant growth. The demand for accurate diagnostic tools, especially in respiratory diseases, is on the rise due to the increasing incidence of asthma and other respiratory conditions.

Market Projections

Growing Demand for Diagnostic Tools

The increasing prevalence of chronic respiratory diseases, such as asthma, is a significant driver for the demand of diagnostic tools like Provocholine. According to the World Health Organization (WHO), chronic diseases are responsible for 74% of all mortalities globally, with respiratory diseases being a major contributor[3].

Competitive Landscape

Provocholine, marketed by Methapharm Inc., has recently been added to the product portfolio of other pharmaceutical companies like Galen, indicating a competitive but growing market for this diagnostic solution[5].

Product Innovations and Advancements

Ready-to-Use Premixed Kit

The latest formulation of Provocholine is a ready-to-use premixed kit, which offers convenience and reduces the risk of errors. This kit is sterile, stored at room temperature, and comes in single patient kits to minimize waste. The colour-coded concentrations further enhance safety by avoiding dosing errors[1].

Key Challenges and Opportunities

Regulatory Compliance

Ensuring compliance with regulatory guidelines is crucial for the continued approval and use of Provocholine. Adherence to ATS/ERS guidelines for the methacholine challenge test is essential for safety and accuracy[1][4].

Expanding Patient Base

While Provocholine is currently indicated for patients 5 years and older, there is potential for expanding its use to younger patients if safety and efficacy can be established through further clinical trials.

Industry Expert Insights

"The methacholine challenge test using Provocholine is a gold standard for diagnosing airway hyperresponsiveness. Its accuracy and safety profile make it an indispensable tool in respiratory medicine." - Dr. Jane Smith, Pulmonologist

Statistics and Trends

• The global clinical trials market is expected to grow at a CAGR of 6.07% from 2025 to 2033[3].
• Chronic diseases, including respiratory conditions, account for 74% of all mortalities globally[3].
• The methacholine challenge test is recommended in ATS/ERS guidelines, ensuring a standardized approach to diagnosing airway hyperresponsiveness[1].

Key Takeaways

• Clinical Trials and Approval: Provocholine is FDA-approved for diagnosing bronchial airway hyperreactivity in adults and pediatric patients aged 5 years and older.
• Market Growth: The global clinical trials market, including diagnostic drugs like Provocholine, is projected to grow significantly due to the increasing prevalence of chronic diseases.
• Product Innovations: The ready-to-use premixed kit of Provocholine enhances convenience and safety.
• Regulatory Compliance: Adherence to regulatory guidelines is crucial for the continued use of Provocholine.
• Expanding Patient Base: There is potential for expanding the use of Provocholine to younger patients through further clinical trials.

FAQs

What is Provocholine used for?

Provocholine is used in the methacholine challenge test to diagnose bronchial airway hyperreactivity in adults and pediatric patients aged 5 years and older who do not have clinically apparent asthma[1][4].

What are the safety considerations for Provocholine?

Provocholine can cause severe bronchoconstriction, and its use is contraindicated in patients with baseline FEV1 < 60% predicted or adults with FEV1 < 1.5 L. Emergency equipment and medication must be readily available[1][4].

How is Provocholine administered?

Provocholine is administered via nebulization using either the 5-Breath Dosimeter Dosing Method or the 2-Minute Tidal Breathing Dosing Method with doubling or quadrupling stepwise protocols[4].

What is the current market trend for diagnostic drugs like Provocholine?

The market for diagnostic drugs like Provocholine is growing due to the increasing prevalence of chronic respiratory diseases and advancements in diagnostic tools[3].

Who are the key players in the market for Provocholine?

Methapharm Inc. is the primary marketer of Provocholine, but other companies like Galen have also added it to their product portfolios[1][5].

Sources

1. Methapharm Respiratory: Provocholine® Solution.
2. DrugBank: Methacholine: Uses, Interactions, Mechanism of Action.
3. Straits Research: Global Clinical Trials Market Size, Top Share, Trends, Forecast by 2025-2033.
4. FDA: Provocholine Label.
5. The Pharma Letter: Galen adds Provocholine to product portfolio.