CLINICAL TRIALS PROFILE FOR ARIDOL KIT

All Clinical Trials for Aridol Kit

Trial ID	Title	Status	Sponsor	Phase	Start Date	Summary
NCT00117182 ↗	Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD	Completed	Pharmaxis	Phase 2	2005-07-01	The purpose of this study is to determine whether the Aridol (mannitol) challenge test can predict response to treatment with inhaled corticosteroids in COPD subjects. Subjects will undergo an Aridol test and then 3 months of treatment with inhaled corticosteroids. The effect on lung function and quality of life will then be measured and correlated with the Aridol test result.
NCT00252291 ↗	Ability of Aridol to Detect Bronchial Hyperresponsiveness in Suspected Asthmatics	Completed	Pharmaxis	Phase 3	2005-11-01	This is a Phase 3 study to determine the sensitivity and specificity of the Aridol bronchial challenge test to detect bronchial hyperresponsiveness in patients with suspected asthma. Patients with suspected asthma of either gender, aged between 6 and 50 years, with only mildly impaired lung function (FEV1 >70%) are to be tested with three different bronchial hyperresponsiveness challenges (Aridol, exercise and methacholine), and the results compared. A clinical diagnosis will also be made at the end of the study.
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 Aridol Kit

Condition Name

Condition Name for Aridol Kit
Intervention	Trials
Asthma	5
Allergic Asthma	1
Cough	1
Cough Variant Asthma	1

Condition MeSH

Condition MeSH for Aridol Kit
Intervention	Trials
Asthma	4
Cough	2
Lung Diseases, Obstructive	1
Lung Diseases	1

Clinical Trial Locations for Aridol Kit

Trials by Country

Trials by Country for Aridol Kit
Location	Trials
Australia	5
Canada	5
United States	1

Trials by US State

Trials by US State for Aridol Kit
Location	Trials
Colorado	1

Clinical Trial Progress for Aridol Kit

Clinical Trial Phase

Clinical Trial Phase for Aridol Kit
Clinical Trial Phase	Trials
Phase 4	1
Phase 3	2
Phase 2	1

Clinical Trial Status

Clinical Trial Status for Aridol Kit
Clinical Trial Phase	Trials
Completed	6
Active, not recruiting	1

Clinical Trial Sponsors for Aridol Kit

Sponsor Name

Sponsor Name for Aridol Kit
Sponsor	Trials
Pharmaxis	3
University of Saskatchewan	3
McMaster University	1

Sponsor Type

Sponsor Type for Aridol Kit
Sponsor	Trials
Other	8
Industry	4

Aridol Kit: Clinical Trials, Market Analysis, and Projections

Introduction

The Aridol Kit, developed by Pharmaxis Ltd, is a mannitol inhalation powder used for the assessment of bronchial hyperresponsiveness, aiding in the diagnosis of asthma. Here, we will delve into the clinical trials, market analysis, and future projections for this innovative diagnostic tool.

Clinical Trials Overview

The Aridol Kit has undergone rigorous clinical testing to establish its safety and efficacy.

Phase III Clinical Trials

Two global Phase III clinical trials were conducted to assess the effectiveness of the Aridol bronchial challenge test. These trials involved patients with symptoms suggestive of asthma and those clinically diagnosed with asthma, aged 6 years and older. The trials demonstrated that Aridol is safe and effective in assessing bronchial hyperresponsiveness[3].

Sensitivity and Specificity

The sensitivity of Aridol in subjects with a physician-diagnosed asthma was found to be 58%, while the specificity in subjects without asthma was 95%. These values were compared to methacholine challenge tests, which are more commonly used but have different response criteria[2].

Adverse Reactions and Safety Profile

The clinical trials revealed a predictable and manageable adverse event profile. Common adverse reactions included headache, pharyngolaryngeal pain, throat irritation, nausea, cough, and dyspnea. No serious adverse reactions were reported, and the test is contraindicated in patients with known hypersensitivity to mannitol or conditions that could be compromised by induced bronchospasm[4].

Market Analysis

Approval and Regulatory Status

The Aridol Kit received FDA approval in October 2010 for the assessment of bronchial hyperresponsiveness in subjects 6 years of age and older. It is the only dry powder bronchial challenge test approved for use in the U.S.[3].

Global Reach

Aridol is approved for use in 19 countries, including major European countries, Australia, and Korea. It has been used by over 44,000 patients worldwide and is included in international guidelines such as the Global Initiative for Asthma (GINA) Report and the U.S. Asthma Management Guidelines[3].

Market Positioning

Aridol is positioned as an easy-to-administer, indirect bronchial challenge test that requires minimal preparation time. It is preferred by many clinicians due to its correlation with airway inflammation, a hallmark of asthma. The test can be conducted in a pulmonary function lab or a physician's office, making it a convenient option for both healthcare providers and patients[3].

Market Projections

Growth Potential

Given its approval and inclusion in international guidelines, Aridol is expected to see significant growth in the market. The increasing prevalence of asthma and the need for accurate diagnostic tools will drive demand for Aridol.

Competitive Landscape

Aridol competes with other bronchial challenge tests, primarily methacholine challenge tests. However, its unique characteristics, such as being a dry powder and inducing constriction through the release of endogenous inflammatory mediators, give it a competitive edge[3].

Expanding Indications

While currently approved for patients 6 years and older, there is potential for future studies to explore its use in younger children, although this would require addressing the current limitation of reliable spirometric measurements in this age group[2].

User and Clinician Feedback

Clinical Utility

Clinicians appreciate Aridol for its ability to provide useful information in diagnosing asthma, especially in situations where other tests may not be as effective. It is seen as a significant addition to the diagnostic toolkit for respiratory diseases[3].

Patient Experience

Patients find the test easy to administer and less invasive compared to other challenge tests. The minimal preparation time and the simplicity of the hand-held device make it a patient-friendly option[3].

Challenges and Limitations

Contraindications and Precautions

Aridol is contraindicated in patients with known hypersensitivity to mannitol or gelatin and in those with medical conditions that could be compromised by induced bronchospasm. It should be used with caution in patients with severe cough, ventilatory impairment, or active respiratory infections[4].

Pediatric Use

The test is not recommended for children under 6 years of age due to their inability to provide reliable spirometric measurements. This limitation may impact its widespread adoption in pediatric settings[2].

Future Directions

Post-Marketing Studies

While the current approval does not require post-marketing studies, future research could focus on expanding the age range, exploring additional indications, and further comparing Aridol with other diagnostic tools[2].

Integration into Clinical Guidelines

Continued inclusion and endorsement by international guidelines will solidify Aridol's position as a standard diagnostic tool for bronchial hyperresponsiveness.

Key Takeaways

• Clinical Efficacy: Aridol has been proven safe and effective in assessing bronchial hyperresponsiveness through two Phase III clinical trials.
• Market Approval: Approved by the FDA and used in 19 countries, it is the only dry powder bronchial challenge test approved in the U.S.
• Global Recognition: Included in international guidelines such as GINA and U.S. Asthma Management Guidelines.
• User Feedback: Clinicians and patients appreciate its ease of use and clinical utility.
• Challenges: Contraindicated in certain patient groups and not recommended for children under 6 years.

Frequently Asked Questions (FAQs)

1. What is the Aridol Kit used for?

The Aridol Kit is used for the assessment of bronchial hyperresponsiveness to aid in the diagnosis of asthma.

2. How does the Aridol test work?

The test involves inhaling increasing doses of dry powder mannitol from a hand-held device, causing airways to narrow and contract when airway inflammation is present. A positive response is indicated by a 15% reduction in lung function from baseline[3].

3. What are the common adverse reactions associated with Aridol?

Common adverse reactions include headache, pharyngolaryngeal pain, throat irritation, nausea, cough, and dyspnea[4].

4. Is Aridol approved for use in children under 6 years of age?

No, Aridol is not approved for use in children under 6 years of age due to their inability to provide reliable spirometric measurements[2].

5. How widely is Aridol used globally?

Aridol is approved and used in 19 countries, including major European countries, Australia, and Korea, and has been used by over 44,000 patients worldwide[3].

Sources:

1. FDA Executive Summary - NDA 22-368 for Aridol[1].
2. FDA Division Director Summary Review - NDA 22-368 for Aridol[2].
3. Pharmaxis Press Release - FDA Approval of Aridol[3].
4. DailyMed - ARIDOL BRONCHIAL CHALLENGE TEST KIT[4].