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

Primary Purpose

Lung Diseases, Obstructive

Status
Completed
Phase
Phase 2
Locations
Australia
Study Type
Interventional
Intervention
Dry powder mannitol
Budesonide 400mcg administered via turbuhaler
Ipratropium bromide 80mcg
Salbutamol 400mcg
Sponsored by
Pharmaxis
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lung Diseases, Obstructive

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Respiratory Clinic
  • Peninsula Medical Centre
  • Wesley Medical Centre
  • Brisbane South Clinical Clinical Research Centre
  • Inala Health Centre
  • Flinders University
  • Respiratory Research Foundation Clinical Trial Centre
  • Peninsula Chest Clinic
  • The rooms of Dr Chris Steinfort
  • The Alfred Hospital
  • Rosebud Medical Centre
  • Sir Charles Gairdner Hospital
  • Mount Medical Centre

Outcomes

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

Full Information

First Posted
June 30, 2005
Last Updated
April 18, 2016
Sponsor
Pharmaxis
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1. Study Identification

Unique Protocol Identification Number
NCT00117182
Brief Title
Aridol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD
Official Title
A Phase II Study to Investigate Mannitol Challenge as a Tool to Predict Treatment Response to Inhaled Corticosteroids in COPD
Study Type
Interventional

2. Study Status

Record Verification Date
April 2016
Overall Recruitment Status
Completed
Study Start Date
July 2005 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2006 (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Pharmaxis

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Diseases, Obstructive

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
140 (false)

8. Arms, Groups, and Interventions

Intervention Type
Drug
Intervention Name(s)
Dry powder mannitol
Intervention Type
Drug
Intervention Name(s)
Budesonide 400mcg administered via turbuhaler
Intervention Type
Drug
Intervention Name(s)
Ipratropium bromide 80mcg
Intervention Type
Drug
Intervention Name(s)
Salbutamol 400mcg
Primary Outcome Measure Information:
Title
Forced expiratory volume in one second (FEV1)
Secondary Outcome Measure Information:
Title
Response dose ratio (RDR)
Title
Dose of provoking stimulus causing a 15%, 12% or 10% fall in FEV1 (PD15, PD12, PD10)
Title
Lung function values
Title
Quality of life assessed by St. George's Respiratory Questionnaire (SGRQ)- total score
Title
COPD clinical control scores (CCQ)
Title
Exacerbation frequency
Title
Days on antibiotics
Title
Days off work or days unable to carry out normal activities
Title
Reversibility of airflow obstruction

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alvin Ing, MBBS
Organizational Affiliation
Bankstown Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Martin Coffey, MBBS
Organizational Affiliation
Rosebud Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Langton, MBBS
Organizational Affiliation
Peninsula Chest Clinic, Frankston
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Steinfort, MBBS
Organizational Affiliation
The Rooms of Dr Steinfort, Geelong
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Trevor WIlliams, MBBS
Organizational Affiliation
The Alfred
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Frith, MBBS
Organizational Affiliation
Flinders Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Chia, MBBS
Organizational Affiliation
Respiratory Research Foundation, Toorak Gardens
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Maureen McKeirnan, MBBS
Organizational Affiliation
Brisbane South Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Fred de Looze, MBBS
Organizational Affiliation
Centre for General Practice for Clinical Trials Unit, Inala
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michael Crookes, MBBS
Organizational Affiliation
Peninsula Medical Centre
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Alan James, MBBS
Organizational Affiliation
Sir Charles Gairdner Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Phillip Thompson, MBBS
Organizational Affiliation
Mount Medical Centre
Official's Role
Principal Investigator
Facility Information:
Facility Name
Respiratory Clinic
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2200
Country
Australia
Facility Name
Peninsula Medical Centre
City
Umina
State/Province
New South Wales
ZIP/Postal Code
2257
Country
Australia
Facility Name
Wesley Medical Centre
City
Auchenflower
State/Province
Queensland
ZIP/Postal Code
4066
Country
Australia
Facility Name
Brisbane South Clinical Clinical Research Centre
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4152
Country
Australia
Facility Name
Inala Health Centre
City
PO BOx 52, Inala
State/Province
Queensland
ZIP/Postal Code
4077
Country
Australia
Facility Name
Flinders University
City
Bedford Park
State/Province
South Australia
ZIP/Postal Code
5042
Country
Australia
Facility Name
Respiratory Research Foundation Clinical Trial Centre
City
Toorak Gardens
State/Province
South Australia
ZIP/Postal Code
5056
Country
Australia
Facility Name
Peninsula Chest Clinic
City
Frankston
State/Province
Victoria
ZIP/Postal Code
3199
Country
Australia
Facility Name
The rooms of Dr Chris Steinfort
City
Geelong
State/Province
Victoria
ZIP/Postal Code
3220
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Rosebud Medical Centre
City
Rosebud
State/Province
Victoria
ZIP/Postal Code
3939
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Mount Medical Centre
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6005
Country
Australia

12. IPD Sharing Statement

Citations:
PubMed Identifier
9309990
Citation
Anderson SD, Brannan J, Spring J, Spalding N, Rodwell LT, Chan K, Gonda I, Walsh A, Clark AR. A new method for bronchial-provocation testing in asthmatic subjects using a dry powder of mannitol. Am J Respir Crit Care Med. 1997 Sep;156(3 Pt 1):758-65. doi: 10.1164/ajrccm.156.3.9701113.
Results Reference
background
PubMed Identifier
11896899
Citation
Brannan JD, Koskela H, Anderson SD, Chan HK. Budesonide reduces sensitivity and reactivity to inhaled mannitol in asthmatic subjects. Respirology. 2002 Mar;7(1):37-44. doi: 10.1046/j.1440-1843.2002.00357.x.
Results Reference
background
PubMed Identifier
12885977
Citation
Burge PS, Calverley PM, Jones PW, Spencer S, Anderson JA. Prednisolone response in patients with chronic obstructive pulmonary disease: results from the ISOLDE study. Thorax. 2003 Aug;58(8):654-8. doi: 10.1136/thorax.58.8.654.
Results Reference
background
PubMed Identifier
14555564
Citation
Koskela HO, Hyvarinen L, Brannan JD, Chan HK, Anderson SD. Sensitivity and validity of three bronchial provocation tests to demonstrate the effect of inhaled corticosteroids in asthma. Chest. 2003 Oct;124(4):1341-9. doi: 10.1378/chest.124.4.1341.
Results Reference
background
PubMed Identifier
15649849
Citation
Leuppi JD, Tandjung R, Anderson SD, Stolz D, Brutsche MH, Bingisser R, Perruchoud AP, Surber C, Knoblauch A, Andersson M, Greiff L, Chan HK, Tamm M. Prediction of treatment-response to inhaled corticosteroids by mannitol-challenge test in COPD. A proof of concept. Pulm Pharmacol Ther. 2005;18(2):83-8. doi: 10.1016/j.pupt.2004.10.005. Epub 2004 Dec 21.
Results Reference
background

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

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