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

Sponsor

Pharmaxis (Industry)

Overall Status

Completed

CT.gov ID

NCT00117182

Collaborator

(none)

140

Enrollment

Locations

Duration (Months)

10.8

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

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

Study Type:

Interventional

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 :

Jul 1, 2005

Study Completion Date :

Aug 1, 2006

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

Criteria

Ages Eligible for Study:

45 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Respiratory Clinic	Sydney	New South Wales	Australia	2200
2	Peninsula Medical Centre	Umina	New South Wales	Australia	2257
3	Wesley Medical Centre	Auchenflower	Queensland	Australia	4066
4	Brisbane South Clinical Clinical Research Centre	Brisbane	Queensland	Australia	4152
5	Inala Health Centre	PO BOx 52, Inala	Queensland	Australia	4077
6	Flinders University	Bedford Park	South Australia	Australia	5042
7	Respiratory Research Foundation Clinical Trial Centre	Toorak Gardens	South Australia	Australia	5056
8	Peninsula Chest Clinic	Frankston	Victoria	Australia	3199
9	The rooms of Dr Chris Steinfort	Geelong	Victoria	Australia	3220
10	The Alfred Hospital	Melbourne	Victoria	Australia	3004
11	Rosebud Medical Centre	Rosebud	Victoria	Australia	3939
12	Sir Charles Gairdner Hospital	Nedlands	Western Australia	Australia	6009
13	Mount Medical Centre	Perth	Western Australia	Australia	6005

Sponsors and Collaborators

Pharmaxis

Investigators

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