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

Tracking Information

First Submitted Date ^ICMJE

June 30, 2005

First Posted Date ^ICMJE

July 4, 2005

Last Update Posted Date

April 20, 2016

Study Start Date ^ICMJE

July 2005

Primary Completion Date

Not Provided

Current Primary Outcome Measures ^ICMJE

Forced expiratory volume in one second (FEV1)

Original Primary Outcome Measures ^ICMJE

Same as current

Change History

Current Secondary Outcome Measures ^ICMJE

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

Original Secondary Outcome Measures ^ICMJE

Same as current

Current Other Pre-specified Outcome Measures

Not Provided

Original Other Pre-specified Outcome Measures

Not Provided

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

A Phase II Study to Investigate Mannitol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD

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.

Detailed Description

Not Provided

Study Type ^ICMJE

Interventional

Study Phase ^ICMJE

Phase 2

Study Design ^ICMJE

Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic

Condition ^ICMJE

Lung Diseases, Obstructive

Intervention ^ICMJE

Drug: Dry powder mannitol
Drug: Budesonide 400mcg administered via turbuhaler
Drug: Ipratropium bromide 80mcg
Drug: Salbutamol 400mcg

Study Arms ^ICMJE

Not Provided

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

140

Original Enrollment ^ICMJE

Same as current

Study Completion Date ^ICMJE

August 2006

Primary Completion Date

Not Provided

Eligibility Criteria ^ICMJE

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.

Sex/Gender ^ICMJE

Sexes Eligible for Study:

All

Ages ^ICMJE

45 Years to 80 Years (Adult, Older Adult)

Accepts Healthy Volunteers ^ICMJE

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Australia

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00117182

Other Study ID Numbers ^ICMJE

DPM-COPD-201

Has Data Monitoring Committee

Not Provided

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement ^ICMJE

Not Provided

Current Responsible Party

Not Provided

Original Responsible Party

Same as current

Current Study Sponsor ^ICMJE

Pharmaxis

Original Study Sponsor ^ICMJE

Same as current

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

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

PRS Account

Pharmaxis

Verification Date

April 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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