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
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|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 Type :||Interventional (Clinical Trial)|
|Enrollment :||140 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
- Forced expiratory volume in one second (FEV1)
- 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
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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|
- 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;
- antibiotic treatment (for respiratory infection).
- 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.
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
|Australia, New South Wales|
|Sydney, New South Wales, Australia, 2200|
|Peninsula Medical Centre|
|Umina, New South Wales, Australia, 2257|
|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|
|Bedford Park, South Australia, Australia, 5042|
|Respiratory Research Foundation Clinical Trial Centre|
|Toorak Gardens, South Australia, Australia, 5056|
|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|
|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|
|Other Study ID Numbers:||
|First Posted:||July 4, 2005 Key Record Dates|
|Last Update Posted:||April 20, 2016|
|Last Verified:||April 2016|
Lung Diseases, Obstructive
Respiratory Tract Diseases
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Reproductive Control Agents
Adrenergic beta-2 Receptor Agonists
Molecular Mechanisms of Pharmacological Action