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| Sponsor: | Pharmaxis |
|---|---|
| Information provided by: | Pharmaxis |
| ClinicalTrials.gov Identifier: | NCT00252291 |
Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Asthma |
Drug: Aridol Drug: Methacholine Procedure: Exercise challenge |
Phase III |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Crossover Assignment Masking: Single Blind Primary Purpose: Diagnostic |
| Official Title: | A Phase III Multicenter Study to Demonstrate the Sensitivity and Specificity of Aridol (Mannitol) Challenge to Predict Bronchial Hyperresponsiveness as Manifested by a Positive Exercise Challenge in Subjects Presenting With Signs and Symptoms Suggestive of Asthma But Without a Definitive Diagnosis |
| Estimated Enrollment: | 240 |
| Study Start Date: | November 2005 |
| Study Completion Date: | September 2006 |
Eligibility| Ages Eligible for Study: | 6 Years to 50 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| United States, Colorado | |
| Colorado Asthma and Allergy Centers, 125 Rampart Way | |
| Denver, Colorado, United States, 80230-6405 | |
| Principal Investigator: | David Pearlman, MD | Colorado Asthma and Allergy Centers, Denver, CO |
More Information
| ClinicalTrials.gov Identifier: | NCT00252291 History of Changes |
| Other Study ID Numbers: | DPM-A-305 |
| Study First Received: | November 10, 2005 |
| Last Updated: | November 29, 2009 |
| Health Authority: | United States: Food and Drug Administration |
|
bronchial hyperresponsiveness |
|
Asthma Bronchial Hyperreactivity Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Mannitol Methacholine Chloride Diuretics, Osmotic Diuretics Natriuretic Agents |
Physiological Effects of Drugs Pharmacologic Actions Cardiovascular Agents Therapeutic Uses Miotics Autonomic Agents Peripheral Nervous System Agents Parasympathomimetics Bronchoconstrictor Agents Respiratory System Agents Muscarinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action |