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Sponsored by: |
Pharmaxis |
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Information provided by: | Pharmaxis |
ClinicalTrials.gov Identifier: | NCT00117182 |
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.
Condition | Intervention | Phase |
---|---|---|
Lung Diseases, Obstructive |
Drug: Dry powder mannitol Drug: Budesonide 400mcg administered via turbuhaler Drug: Ipratropium bromide 80mcg Drug: Salbutamol 400mcg |
Phase II |
Study Type: | Interventional |
Study Design: | Diagnostic, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study |
Official Title: | A Phase II Study to Investigate Mannitol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD |
Estimated Enrollment: | 140 |
Study Start Date: | July 2005 |
Estimated Study Completion Date: | August 2006 |
Ages Eligible for Study: | 45 Years to 80 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
As determined by the investigator, are capable and willing to:
The subject must be in stable clinical condition at the time of, and for a period of 14 days prior to, their recruitment into the study. Stable clinical condition is defined as lack of:
Exclusion Criteria:
Australia, New South Wales | |
Respiratory Clinic | |
Sydney, New South Wales, Australia, 2200 | |
Peninsula Medical Centre | |
Umina, New South Wales, Australia, 2257 | |
Australia, Queensland | |
Brisbane South Clinical Clinical Research Centre | |
Brisbane, Queensland, Australia, 4152 | |
Wesley Medical Centre | |
Auchenflower, Queensland, Australia, 4066 | |
Inala Health Centre | |
PO BOx 52, Inala, Queensland, Australia, 4077 | |
Australia, South Australia | |
Respiratory Research Foundation Clinical Trial Centre | |
Toorak Gardens, South Australia, Australia, 5056 | |
Flinders University | |
Bedford Park, South Australia, Australia, 5042 | |
Australia, Victoria | |
Peninsula Chest Clinic | |
Frankston, Victoria, Australia, 3199 | |
The rooms of Dr Chris Steinfort | |
Geelong, Victoria, Australia, 3220 | |
Rosebud Medical Centre | |
1239- 1241 Point Nepean Rd, Rosebud, Victoria, Australia, 3939 | |
The Alfred Hospital | |
Melbourne, Victoria, Australia, 3004 | |
Australia, Western Australia | |
Sir Charles Gairdner Hospital | |
Nedlands, Western Australia, Australia, 6009 | |
Mount Medical Centre | |
Perth, Western Australia, Australia, 6005 |
Principal Investigator: | Alvin Ing, MBBS | Bankstown Hospital |
Principal Investigator: | Martin Coffey, MBBS | Rosebud Medical Centre |
Principal Investigator: | David Langton, MBBS | Peninsula Chest Clinic, Frankston |
Principal Investigator: | Chris Steinfort, MBBS | The Rooms of Dr Steinfort, Geelong |
Principal Investigator: | Trevor WIlliams, MBBS | The Alfred Hospital, Melbourne |
Principal Investigator: | Peter Frith, MBBS | Flinders Medical Centre |
Principal Investigator: | Michael Chia, MBBS | Respiratory Research Foundation, Toorak Gardens |
Principal Investigator: | Maureen McKeirnan, MBBS | Brisbane South Medical Centre |
Principal Investigator: | Fred de Looze, MBBS | Centre for General Practice for Clinical Trials Unit, Inala |
Principal Investigator: | Peter Frith, MBBS | Flinders Medical Centre |
Principal Investigator: | Michael Crookes, MBBS | Peninsula Medical Centre |
Principal Investigator: | Alan James, MBBS | Sir Charles Gairdner Hospital |
Principal Investigator: | Phillip Thompson, MBBS | Mount Medical Centre |
Study ID Numbers: | DPM-COPD-201 |
Study First Received: | June 30, 2005 |
Last Updated: | August 27, 2008 |
ClinicalTrials.gov Identifier: | NCT00117182 |
Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Lung Diseases, Obstructive Ipratropium Respiratory Tract Diseases Mannitol |
Bromides Lung Diseases Albuterol Budesonide |
Respiratory System Agents Neurotransmitter Agents Cholinergic Antagonists Molecular Mechanisms of Pharmacological Action Adrenergic beta-Agonists Adrenergic Agents Diuretics, Osmotic Diuretics Physiological Effects of Drugs Anti-Asthmatic Agents Cardiovascular Agents |
Reproductive Control Agents Cholinergic Agents Pharmacologic Actions Adrenergic Agonists Tocolytic Agents Natriuretic Agents Autonomic Agents Therapeutic Uses Peripheral Nervous System Agents Bronchodilator Agents |