Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12613000699763
Ethics application status
Approved
Date submitted
20/06/2013
Date registered
26/06/2013
Date last updated
26/06/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
Nicotinamide and innate immunity in patients with bronchiectasis
Scientific title
Enhanced innate immunity and killing of respiratory pathogens by nicotinamide in patients with bronchiectasis
Secondary ID [1] 282707 0
NONE
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bronchiectasis 289421 0
Condition category
Condition code
Respiratory 289750 289750 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will take oral nicotinamide capsules twice daily in one of the 4 dosage groups for a total duration of 2 weeks:- 1500mg twice daily
2000mg twice daily
2500mg twice daily
3000mg twice daily
compliance will be ensured by capsules count at every follow up visit, blood will be collected for nicotinamide level prior to start of nicotinamide taking and then at every follow up visit.
Intervention code [1] 287368 0
Prevention
Intervention code [2] 287403 0
Treatment: Drugs
Comparator / control treatment
Nil
Control group
Uncontrolled

Outcomes
Primary outcome [1] 289835 0
Dose of nicotinamide required to achieve serum level of 1 mM, this will be assessed by collecting blood samples for serum nicotinamide level analysis at each follow up visits from visit 2 to visit 5
Timepoint [1] 289835 0
two weeks
Secondary outcome [1] 303348 0
Counts of surviving bacterial colony-forming units after inoculation of the pathogen with nicotinamide treated blood
Timepoint [1] 303348 0
two weeks
Secondary outcome [2] 303349 0
Serum Level of C/EBPe expression
Timepoint [2] 303349 0
two weeks
Secondary outcome [3] 303438 0
serum lactoferrin level
Timepoint [3] 303438 0
two weeks
Secondary outcome [4] 303439 0
serum cathelicidin level
Timepoint [4] 303439 0
two weeks

Eligibility
Key inclusion criteria
- Male or female aged between 18 to 80 years old
- able to provide written consent form
- Patients with confirmed bronchiectasis by High resolution
CT scan
- history of at least one pulmonary exacerbation in the
past 12 months
- healthy volunteers should be never smoker with no
underlying acute or chronic medical conditions and not
taking regular medications
Minimum age
18 Years
Maximum age
80 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
- Pregnant or lactating women
- patients with significant medical conditions other than
bronchiectasis
- patients with significant abnormal liver function or with
liver cirrhosis
- patients with a history of non-adherence with medications

Study design
Purpose of the study
Prevention
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Other
Other design features
One volunteer and one bronchiectasis patient will be allocated to each of the 4 dosing groups by sequence.
Phase
Phase 1
Type of endpoint/s
Pharmacokinetics / pharmacodynamics
Statistical methods / analysis
The primary outcome nicotinamide levels will be described and analysed at baseline, 48hours, 1 week and 2 weeks.
Descriptives will be produced for all other study outcomes at each time point.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/07/2013
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
8
Accrual to date
Final
Recruitment outside Australia
Country [1] 5154 0
New Zealand
State/province [1] 5154 0
Auckland

Funding & Sponsors
Funding source category [1] 287478 0
Hospital
Name [1] 287478 0
Respiratory Research Fund, Middlemore Hospital
Country [1] 287478 0
New Zealand
Primary sponsor type
Hospital
Name
Dr Conroy Wong, Middlemore Hospital
Address
Middlemore Hospital
Private Bag 93311
Otahuhu
Auckland 1640
New Zealand
Country
New Zealand
Secondary sponsor category [1] 286220 0
Charities/Societies/Foundations
Name [1] 286220 0
Centre for Clinical Research and effective practice
Address [1] 286220 0
Centre for Clinical Research and effective practice
Private Bag 93311
Otahuhu
Auckland 1640
Country [1] 286220 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 289453 0
Northern A Health and Disability Ethics Committee
Ethics committee address [1] 289453 0
Ministry of Health
1 the Terrace
PO Box 5013
Wellington
6011
Ethics committee country [1] 289453 0
New Zealand
Date submitted for ethics approval [1] 289453 0
26/02/2013
Approval date [1] 289453 0
15/03/2013
Ethics approval number [1] 289453 0
13/NTA/28

Summary
Brief summary
We aim to determine the dose of nicotinamide (NAM) that achieves a serum level of at least 1 mM, and also to assess the effect of nicotinamide on upregulation of neutrophil function and bacterial killing in both patients with bronchiectasis and healthy volunteers.

We want to prove if nicotinamide may augment neutrophil function and enhance the killing of respiratory pathogens in patients with bronchiectasis
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 40922 0
Dr Conroy Wong
Address 40922 0
Respiratory Services
Middlemore Hospital
Private bag 93311
Otahuhu
Auckland 1640
New Zealand
Country 40922 0
New Zealand
Phone 40922 0
+64 9 276 0000
Fax 40922 0
+64 9 270 9737
Email 40922 0
[email protected]
Contact person for public queries
Name 40923 0
Ms Cecilia Tong
Address 40923 0
Centre for Clinical Research and effective practice
Private bag 93311
Otahuhu
Auckland 1640
New Zealand
Country 40923 0
New Zealand
Phone 40923 0
+64 9 276 0000
Fax 40923 0
+64 9 270 9737
Email 40923 0
[email protected]
Contact person for scientific queries
Name 40924 0
Dr Conroy Wong
Address 40924 0
Respiratory Services
Middlemore Hospital
Private bag 93311
Otahuhu
Auckland 1640
New Zealand
Country 40924 0
New Zealand
Phone 40924 0
+64 9 276 0000
Fax 40924 0
+64 9 270 9737
Email 40924 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
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.