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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.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dry powder mannitol | Drug | |||
| Budesonide 400mcg administered via turbuhaler | Drug | |||
| Ipratropium bromide 80mcg | Drug | |||
| Salbutamol 400mcg | Drug |
| Measure | Description | Time Frame |
|---|---|---|
| Forced expiratory volume in one second (FEV1) |
| Measure | Description | Time Frame |
|---|---|---|
| Response dose ratio (RDR) | ||
| Dose of provoking stimulus causing a 15%, 12% or 10% fall in FEV1 (PD15, PD12, PD10) | ||
| Lung function values |
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Inclusion Criteria:
Diagnosis of COPD (history, spirometry, symptoms including chronic cough and/or shortness of breath that is worse on exertion and/or excess sputum production)
Aged 45 - 80 years
Have pre-bronchodilator FEV1 > 1.4 litres and at least 60% of predicted for height, age and gender and a post-bronchodilator FEV1 <80% of predicted for height, age and gender
Post-bronchodilator FEV1/FVC < 70 %
≥ 10 pack years smoking history
As determined by the investigator, are capable and willing to:
Are capable of, and have given informed consent to, participating in this study in accordance with local regulations.
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:
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| Name | Affiliation | Role |
|---|---|---|
| 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 | 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 |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Respiratory Clinic | Sydney | New South Wales | 2200 | Australia | ||
| Peninsula Medical Centre |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 9309990 | Background | Anderson SD, Brannan J, Spring J, Spalding N, Rodwell LT, Chan K, Gonda I, Walsh A, Clark AR. A new method for bronchial-provocation testing in asthmatic subjects using a dry powder of mannitol. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):758-65. doi: 10.1164/ajrccm.156.3.9701113. | |
| 11896899 | Background | Brannan JD, Koskela H, Anderson SD, Chan HK. Budesonide reduces sensitivity and reactivity to inhaled mannitol in asthmatic subjects. Respirology. 2002 Mar;7(1):37-44. doi: 10.1046/j.1440-1843.2002.00357.x. |
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| Quality of life assessed by St. George's Respiratory Questionnaire (SGRQ)- total score |
| COPD clinical control scores (CCQ) |
| Exacerbation frequency |
| Days on antibiotics |
| Days off work or days unable to carry out normal activities |
| Reversibility of airflow obstruction |
| Michael Crookes, MBBS |
| Peninsula Medical Centre |
| Principal Investigator |
| Alan James, MBBS | Sir Charles Gairdner Hospital | Principal Investigator |
| Phillip Thompson, MBBS | Mount Medical Centre | Principal Investigator |
| Umina |
| New South Wales |
| 2257 |
| Australia |
| Wesley Medical Centre | Auchenflower | Queensland | 4066 | Australia |
| Brisbane South Clinical Clinical Research Centre | Brisbane | Queensland | 4152 | Australia |
| Inala Health Centre | PO BOx 52, Inala | Queensland | 4077 | Australia |
| Flinders University | Bedford Park | South Australia | 5042 | Australia |
| Respiratory Research Foundation Clinical Trial Centre | Toorak Gardens | South Australia | 5056 | Australia |
| Peninsula Chest Clinic | Frankston | Victoria | 3199 | Australia |
| The rooms of Dr Chris Steinfort | Geelong | Victoria | 3220 | Australia |
| The Alfred Hospital | Melbourne | Victoria | 3004 | Australia |
| Rosebud Medical Centre | Rosebud | Victoria | 3939 | Australia |
| Sir Charles Gairdner Hospital | Nedlands | Western Australia | 6009 | Australia |
| Mount Medical Centre | Perth | Western Australia | 6005 | Australia |
| 12885977 | Background | Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA. Prednisolone response in patients with chronic obstructive pulmonary disease: results from the ISOLDE study. Thorax. 2003 Aug;58(8):654-8. doi: 10.1136/thorax.58.8.654. |
| 14555564 | Background | Koskela HO, Hyvarinen L, Brannan JD, Chan HK, Anderson SD. Sensitivity and validity of three bronchial provocation tests to demonstrate the effect of inhaled corticosteroids in asthma. Chest. 2003 Oct;124(4):1341-9. doi: 10.1378/chest.124.4.1341. |
| 15649849 | Background | Leuppi JD, Tandjung R, Anderson SD, Stolz D, Brutsche MH, Bingisser R, Perruchoud AP, Surber C, Knoblauch A, Andersson M, Greiff L, Chan HK, Tamm M. Prediction of treatment-response to inhaled corticosteroids by mannitol-challenge test in COPD. A proof of concept. Pulm Pharmacol Ther. 2005;18(2):83-8. doi: 10.1016/j.pupt.2004.10.005. Epub 2004 Dec 21. |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| ID | Term |
|---|---|
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D019819 | Budesonide |
| D009241 | Ipratropium |
| D000420 | Albuterol |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D009930 | Organic Chemicals |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D000588 | Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
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