We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00117182
Recruitment Status : Completed
First Posted : July 4, 2005
Last Update Posted : April 20, 2016
Information provided by:

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
 (submitted: July 1, 2005)
Forced expiratory volume in one second (FEV1)
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 1, 2005)
  • 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
 (submitted: July 1, 2005)
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 No
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