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

This study has been completed.
Sponsor:
Information provided by:
Pharmaxis
ClinicalTrials.gov Identifier:
NCT00117182
First received: June 30, 2005
Last updated: August 27, 2008
Last verified: August 2008
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by Pharmaxis:

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

Estimated Enrollment: 140
Study Start Date: July 2005
Estimated Study Completion Date: August 2006
  Eligibility

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00117182

Locations
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
Rosebud Medical Centre
1239- 1241 Point Nepean Rd, Rosebud, Victoria, Australia, 3939
Peninsula Chest Clinic
Frankston, Victoria, Australia, 3199
The rooms of Dr Chris Steinfort
Geelong, Victoria, Australia, 3220
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
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
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 Hospital, Melbourne
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:
ClinicalTrials.gov Identifier: NCT00117182     History of Changes
Other Study ID Numbers: DPM-COPD-201
Study First Received: June 30, 2005
Last Updated: August 27, 2008
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Additional relevant MeSH terms:
Lung Diseases
Lung Diseases, Obstructive
Respiratory Tract Diseases
Albuterol
Ipratropium
Budesonide
Mannitol
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Tocolytic Agents
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Antagonists
Cholinergic Agents
Diuretics, Osmotic
Diuretics
Natriuretic Agents
Cardiovascular Agents
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on August 18, 2014