Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD

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ClinicalTrials.gov Identifier: NCT00117182

Recruitment Status : Completed

First Posted : July 4, 2005

Last Update Posted : April 20, 2016

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by:

Pharmaxis

Study Description

Brief Summary:

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 or disease	Intervention/treatment	Phase
Lung Diseases, Obstructive	Drug: Dry powder mannitol Drug: Budesonide 400mcg administered via turbuhaler Drug: Ipratropium bromide 80mcg Drug: Salbutamol 400mcg	Phase 2

Study Design

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Study Type :	Interventional (Clinical Trial)
Enrollment :	140 participants
Allocation:	Non-Randomized
Intervention Model:	Single Group Assignment
Masking:	None (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
Study Start Date :	July 2005
Study Completion Date :	August 2006

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

Drug Information available for: Mannitol

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

Forced expiratory volume in one second (FEV1)

Secondary Outcome Measures :

Response dose ratio (RDR)
Dose of provoking stimulus causing a 15%, 12% or 10% fall in FEV1 (PD15, PD12, PD10)
Lung function values
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

Eligibility Criteria

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Ages Eligible for Study:	45 Years to 80 Years (Adult, Older Adult)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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:
- perform all of the techniques necessary to measure lung function;
- administer the dry powder mannitol.
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:
- change in sputum production (volume, colour, consistency);
- increased cough;
- worsening dyspnoea;
- increased malaise, fatigue or lethargy;
- reduction in exercise tolerance;
- fever;
- antibiotic treatment (for respiratory infection).

Exclusion Criteria:

Investigators, site personnel directly affiliated with this study, and their immediate families. Immediate family is defined as a spouse, parent, child or sibling, whether biologically or legally adopted.
Subjects receiving treatment with inhaled corticosteroids (including combination therapies, e.g. Seretide®, Symbicort®) or oral corticosteroids within the last 6 weeks.
Subjects who have had an exacerbation or a chest infection within the 2 weeks prior to the study.
Subjects receiving antibiotic treatment for respiratory infection.
Known diagnosis of asthma or allergic rhinitis.
Myocardial infarction in the six months prior to enrolment.
Cerebral vascular accident in the six months prior to enrolment.
Ocular surgery in the three months prior to enrolment.
Abdominal surgery in the three months prior to enrolment.
Active tuberculosis (TB).
Lung cancer or any other malignancies, which are considered by the investigator as a contraindication to participating in the study.
Lung disease other than COPD (e.g. bronchiectasis).
Uncontrolled insulin-dependant or non-insulin dependant diabetes, i.e. >10% HbA1c.
Female subjects of reproductive capability, not using a reliable form of contraception
Inability to obtain informed consent from the subject or subject's authorised representative.
Subjects who have participated in another investigative drug study parallel to, or within 4 weeks of, study entry.
Known intolerance to mannitol.
Uncontrolled hypertension - systolic blood pressure (BP) > 200 mmHg and or diastolic BP > 100 mmHg.
Planned pulmonary rehabilitation.
Have had major abdominal, chest or brain surgery in the three months prior to enrolment.
Have known cerebral, aortic or abdominal aneurysm.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00117182

Locations

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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
Peninsula Chest Clinic
Frankston, Victoria, Australia, 3199
The rooms of Dr Chris Steinfort
Geelong, Victoria, Australia, 3220
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Rosebud Medical Centre
Rosebud, Victoria, Australia, 3939
Australia, Western Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia, 6009
Mount Medical Centre
Perth, Western Australia, Australia, 6005

Sponsors and Collaborators

Pharmaxis

Investigators

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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
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

Publications:

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.

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.

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.

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.

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.

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ClinicalTrials.gov Identifier:	NCT00117182
Other Study ID Numbers:	DPM-COPD-201
First Posted:	July 4, 2005 Key Record Dates
Last Update Posted:	April 20, 2016
Last Verified:	April 2016

Additional relevant MeSH terms:

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Lung Diseases Lung Diseases, Obstructive Respiratory Tract Diseases Budesonide Mannitol Bromides Albuterol Ipratropium Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents	Glucocorticoids Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Anticonvulsants Tocolytic Agents Reproductive Control Agents Adrenergic beta-2 Receptor Agonists Adrenergic beta-Agonists Adrenergic Agonists Adrenergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Diuretics, Osmotic Diuretics Natriuretic Agents

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