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| Sponsor: | Pharmaxis |
|---|---|
| Information provided by: | Pharmaxis |
| ClinicalTrials.gov Identifier: | NCT00117182 |
Purpose
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: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| 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 |
Eligibility| 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:
Contacts and Locations| Australia, New South Wales | |
| Respiratory Clinic | |
| Sydney, New South Wales, Australia, 2200 | |
| Peninsula Medical Centre | |
| Umina, New South Wales, Australia, 2257 | |
| Australia, Queensland | |
| Wesley Medical Centre | |
| Auchenflower, Queensland, Australia, 4066 | |
| Brisbane South Clinical Clinical Research Centre | |
| Brisbane, Queensland, Australia, 4152 | |
| Inala Health Centre | |
| PO BOx 52, Inala, Queensland, Australia, 4077 | |
| Australia, South Australia | |
| Flinders University | |
| Bedford Park, South Australia, Australia, 5042 | |
| Respiratory Research Foundation Clinical Trial Centre | |
| Toorak Gardens, South Australia, Australia, 5056 | |
| Australia, Victoria | |
| Rosebud Medical Centre | |
| 1239- 1241 Point Nepean Rd, Rosebud, Victoria, Australia, 3939 | |
| Peninsula Chest Clinic | |
| Frankston, Victoria, Australia, 3199 | |
| The rooms of Dr Chris Steinfort | |
| Geelong, Victoria, Australia, 3220 | |
| 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: | Michael Crookes, MBBS | Peninsula Medical Centre |
| Principal Investigator: | Alan James, MBBS | Sir Charles Gairdner Hospital |
| Principal Investigator: | Phillip Thompson, MBBS | Mount Medical Centre |
More Information
| ClinicalTrials.gov Identifier: | NCT00117182 History of Changes |
| Other Study ID Numbers: | DPM-COPD-201 |
| Study First Received: | June 30, 2005 |
| Last Updated: | August 27, 2008 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
|
Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Albuterol Ipratropium Budesonide Mannitol Tocolytic Agents Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists |
Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Anti-Asthmatic Agents Respiratory System Agents Cholinergic Antagonists Cholinergic Agents Diuretics, Osmotic Diuretics Natriuretic Agents Cardiovascular Agents Glucocorticoids |