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Sponsored by: |
Pharmaxis |
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Information provided by: | Pharmaxis |
ClinicalTrials.gov Identifier: | NCT00252291 |
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 |
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Asthma |
Drug: Aridol Drug: Methacholine Procedure: Exercise challenge |
Phase III |
Study Type: | Interventional |
Study Design: | Diagnostic, Randomized, Single Blind, Active Control, Crossover Assignment, Safety/Efficacy Study |
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 |
Ages Eligible for Study: | 6 Years to 50 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
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 |
Study ID Numbers: | DPM-A-305 |
Study First Received: | November 10, 2005 |
Last Updated: | November 7, 2007 |
ClinicalTrials.gov Identifier: | NCT00252291 |
Health Authority: | United States: Food and Drug Administration |
bronchial hyperresponsiveness |
Signs and Symptoms Hypersensitivity Lung Diseases, Obstructive Respiratory Tract Diseases Mannitol Lung Diseases |
Methacholine Chloride Hypersensitivity, Immediate Asthma Bronchial Hyperreactivity Respiratory Hypersensitivity |
Parasympathomimetics Respiratory System Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchial Diseases Immune System Diseases Cholinergic Agonists Bronchoconstrictor Agents |
Miotics Physiological Effects of Drugs Cholinergic Agents Pharmacologic Actions Autonomic Agents Therapeutic Uses Muscarinic Agonists Peripheral Nervous System Agents |