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Trial registered on ANZCTR


Registration number
ACTRN12614000617662
Ethics application status
Approved
Date submitted
13/05/2014
Date registered
11/06/2014
Date last updated
11/06/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
A study to measure markers in the breath of patients with Chronic Obstructive Pulmonary Disease (COPD)
Scientific title
A randomized, double blind study testing the effect of indacaterol on exhaled and circulatory biomarkers of Chronic Obstructive Pulmonary Disease (COPD).
Secondary ID [1] 284596 0
Nil
Universal Trial Number (UTN)
Trial acronym
Nil
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 291893 0
Condition category
Condition code
Respiratory 292236 292236 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Indacaterol 300micrograms daily for 10 days
We are not able to monitor adherence but will test changes in exhaled molecules on Indacaterol.
Indacaterol is an inhaler
Intervention code [1] 289369 0
Treatment: Drugs
Comparator / control treatment
Placebo - Inhaler with propellant alone
Healthy controls receive no treatment at all
Control group
Placebo

Outcomes
Primary outcome [1] 292109 0
Effect of drug on volatile organic compounds. The drug will be given to the subject for 10 days. At the end of this period the patient will blow into a tube that would collect the exhaled breath. That tube will be sent for analysis to determine the number and concentration of organic compounds.
Timepoint [1] 292109 0
10 days
Secondary outcome [1] 308217 0
Improvement in lung function including FEV1. FEV1 is meaured by spirometry
Timepoint [1] 308217 0
10 days

Eligibility
Key inclusion criteria
The people eligible for the study are patients with 1)COPD. based on the criteria described below. 2) Healthy controls with no COPD and within the same age range as subjects with COPD.
1. GOLD Criteria for severity of COPD
a. Mild – FEV1/FVC< 70%, FEV1< 80%
b. Moderate – FEV1/FVC< 70%, FEV1 50-80%
2. COPD chronic bronchitis or Emphysema
3. Age – 50-70 years
4. males and females
Minimum age
50 Years
Maximum age
70 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. Present smokers
2. Severe CCF
3. Liver, renal failure
4. Diabetes
5. On immunosuppressive drugs
6. Auto-immune conditions such RA
7. Vascular disease – Scleroderma , SLE
8. Any history of asthma
9. Exacerbations in the last 6 weeks
10. Women of childbearing potential not using the contraception method(s) specified in this study (specify), as well as women who are breastfeeding
11. Known sensitivity to study drug(s) or class of study drug(s)
12. Patients with severe medical condition(s) that in the view of the investigator prohibits participation in the study (specify as required)

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed. Patients would be recruited from the public. They would have a diagnosis of COPD and fulfill the inclusion and exclusion criteria. They would then be randomised to a treatment. The treatment is an inhaler. The palcebo and treatment inhaler are identical. Only COPD patients would be randomised.
Healthy volunteers would be recruited from the regular volunteers from theLung Institute of Western Australia
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
There would be simple randomisation using a randomisation table from a statistic book. The subjects would be randomly given an inhaler that may be placebo or treatment. The investigator is blinded to this.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Nil of note
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
We initially did a pilot study to identify differences in exhaled volatile organic compunds (VOCs) between healthy and COPD subjects. Based on the differences between healthy and COPD, the data was analysed by RM-ANOVA. The mean SD was a difference of 5 VOCs and for a desired change of at least 5 VOCS difference p = 0.05 and a power of 0.8, the group sizes will be n=25/group for an RM-ANOVA analysis (PASS, v13, NCSS, USA).

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
23/06/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
WA
Recruitment hospital [1] 2461 0
Royal Perth Hospital - Perth
Recruitment hospital [2] 2462 0
Sir Charles Gairdner Hospital - Nedlands
Recruitment postcode(s) [1] 8118 0
6000 - City Delivery Centre
Recruitment postcode(s) [2] 8119 0
6009 - Nedlands

Funding & Sponsors
Funding source category [1] 289228 0
Commercial sector/Industry
Name [1] 289228 0
Novartis
Country [1] 289228 0
Australia
Primary sponsor type
Charities/Societies/Foundations
Name
Lung Institute of Western Australia
Address
The Lung Insititue of Western Australia
Ground Floor, E block
Sir Charles Gairdner Hospital
Verdun Street
Nedlands
6009
Perth
Western Australia
Country
Australia
Secondary sponsor category [1] 287900 0
Other Collaborative groups
Name [1] 287900 0
Chemcentre
Address [1] 287900 0
Resources and Chemistry Precinct
Level 2, South Wing, Building 500
Corner Manning Road and Townsing Drive
Bentley WA 6102
Country [1] 287900 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290997 0
Royal Perth Human Ethics committee
Ethics committee address [1] 290997 0
Ethics committee country [1] 290997 0
Australia
Date submitted for ethics approval [1] 290997 0
Approval date [1] 290997 0
14/09/2012
Ethics approval number [1] 290997 0
EC 2012/125

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes
Attachments [1] 51 51 0 0
/AnzctrAttachments/366326-Protocol Yuben Moodley Biomarker Indacaterol study final version 2 26Apr2013 correction labelling inhaler (2).docx

Contacts
Principal investigator
Name 48362 0
A/Prof Yuben Moodley
Address 48362 0
School of Medicine and Pharmacology-University of Western Asutralia
4th Floor
MRF Building
50 Murray Street
Perth
WA
6000
Country 48362 0
Australia
Phone 48362 0
+61 8 92240232
Fax 48362 0
+61 8 92240246
Email 48362 0
[email protected]
Contact person for public queries
Name 48363 0
Yuben Moodley
Address 48363 0
School of Medicine and Pharmacology-UWA
4th Floor
MRF Building
50 Murray Street
Perth
6000
WA
Country 48363 0
Australia
Phone 48363 0
+61 8 92240232
Fax 48363 0
+61 8 92240246
Email 48363 0
[email protected]
Contact person for scientific queries
Name 48364 0
Yuben Moodley
Address 48364 0
School of Medicine and Pharmacology
University of Western Australia
4th Floor
MRF Building
50 Murray Street
Perth
6000
WA
Country 48364 0
Australia
Phone 48364 0
+61 8 92240232
Fax 48364 0
+61 8 92240246
Email 48364 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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