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Trial registered on ANZCTR


Registration number
ACTRN12616000140459
Ethics application status
Approved
Date submitted
3/02/2016
Date registered
5/02/2016
Date last updated
5/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
Effect of inhaled airway widening medication on exhaled nitric oxide (an airway inflammation marker) in chronic obstructive pulmonary disease
Scientific title
Effect of inhaled beta-2-agonist salbutamol on exhaled nitric oxide in chronic obstructive pulmonary disease
Secondary ID [1] 288476 0
nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
chronic obstructive pulmonary disease 297515 0
Condition category
Condition code
Respiratory 297714 297714 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Observation of exhaled nitric oxide immediately before and then 15 minutes after 400 micrograms of inhaled salbutamol (4 puffs of participants' usual reliever medication). Exhaled nitric oxide measurement required participants to blow out through a tube at a constant flow rate using visual feedback from a computer screen giving a target flow rate. Exhaled nitric oxide measurements were performed immediately before and then 15 minutes after the dose of inhaled salbutamol with no further follow-up.
Intervention code [1] 293814 0
Not applicable
Comparator / control treatment
n/a
Control group
Uncontrolled

Outcomes
Primary outcome [1] 297243 0
Change in exhaled nitric oxide a was assessed by measurement of exhaled nitric oxide immediately before and 15 minutes after the dose of inhaled salbutamol. Measurements were undertaken using a chemiluminescence nitric oxide analyser according to American Thoracic Society and European Respiratory Society guidelines.
Timepoint [1] 297243 0
Immediately prior to and 15 min after dose of inhaled salbutamol.
Secondary outcome [1] 320451 0
Change in flow-independent exhaled nitric oxide parameter, JawNO (the maximal flux of nitric oxide from the airway compartment). Measurements of exhaled nitric oxide were undertaken using a chemiluminescence nitric oxide analyser at multiple expiratory flow rates. From these, JawNO was calculated.
Timepoint [1] 320451 0
Immediately prior to and 15 min after dose of inhaled salbutamol.
Secondary outcome [2] 320487 0
Change in flow-independent exhaled nitric oxide parameter, CANO (the distal airway/alveolar concentration of nitric oxide). Measurements of exhaled nitric oxide were undertaken using a chemiluminescence nitric oxide analyser at multiple expiratory flow rates. From these, CANO was calculated.
Timepoint [2] 320487 0
Immediately prior to and 15 min after dose of inhaled salbutamol.

Eligibility
Key inclusion criteria
Diagnosis of chronic obstructive pulmonary disease, aged 45 years or older, smoking history of more than 10 pack years, taking inhaled salbutamol as required, post-bronchodilator FEV1/FVC of less than 70% and FEV1 < 80% predicted.
Minimum age
45 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No exacerbations or use of antibiotics in the two weeks preceding study participation. No patients with diagnosed lung cancer, bronchiectasis, or other significant co-morbidity. No patients unable to perform the 50mL/s exhaled nitric oxide manoeuvres in accordance with American Thoracic Society guidelines

Study design
Purpose
Duration
Cross-sectional
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Participant numbers needed to achieve study objectives were estimated from previously published work in asthma by other groups. Changes in pre- and post-bronchodilator measurements will be assessed for normal vs. non-normal distribution and appropriate parametric (paired t-test) or non-parametric tests used.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 7571 0
New Zealand
State/province [1] 7571 0
Otago

Funding & Sponsors
Funding source category [1] 292818 0
University
Name [1] 292818 0
University of Otago
Address [1] 292818 0
University of Otago, PO Box 56, Dunedin, 9054
Country [1] 292818 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
University of Otago, PO Box 56, Dunedin, 9054
Country
New Zealand
Secondary sponsor category [1] 291560 0
None
Name [1] 291560 0
Address [1] 291560 0
Country [1] 291560 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 294324 0
Northern B Health and Disability Ethic Committee
Ethics committee address [1] 294324 0
Health and Disability Ethics Committees
Ministry of Health
C/- MEDSAFE, Level 6, Deloitte House
10 Brandon Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 294324 0
New Zealand
Date submitted for ethics approval [1] 294324 0
Approval date [1] 294324 0
03/11/2014
Ethics approval number [1] 294324 0
14/NTB/164

Summary
Brief summary
Exhaled nitric oxide (FENO) is a marker of airway inflammation, and high levels are associated with greater responsiveness of airways disease to steroid treatment. Studies have shown that, in the presence of narrowed airways in asthma, FENO levels can be reduced, but the effects in smoking related chronic obstructive lung disease (COPD) are unknown. This is important as we may be underestimating FENO levels in COPD patients who might otherwise benefit from steroid therapy. We aim to perform FENO measurements in twenty COPD patients before and after bronchodilator (reliever) therapy, to test the hypothesis that FENO increases with wider airway calibre.
Trial website
Trial related presentations / publications
not applicable
Public notes

Contacts
Principal investigator
Name 63306 0
Dr Jack Dummer
Address 63306 0
Otago Respiratory Research Unit
Dunedin School of Medicine
PO Box 56
Dunedin 9054
Country 63306 0
New Zealand
Phone 63306 0
+64 3 4709362
Fax 63306 0
Email 63306 0
jack.dummer@otago.ac.nz
Contact person for public queries
Name 63307 0
Dr Jack Dummer
Address 63307 0
Otago Respiratory Research Unit
Dunedin School of Medicine
PO Box 56
Dunedin 9054
Country 63307 0
New Zealand
Phone 63307 0
+64 3 4709362
Fax 63307 0
Email 63307 0
jack.dummer@otago.ac.nz
Contact person for scientific queries
Name 63308 0
Dr Jack Dummer
Address 63308 0
Otago Respiratory Research Unit
Dunedin School of Medicine
PO Box 56
Dunedin 9054
Country 63308 0
New Zealand
Phone 63308 0
+64 3 4709362
Fax 63308 0
Email 63308 0
jack.dummer@otago.ac.nz

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary