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Trial registered on ANZCTR


Registration number
ACTRN12609000481279
Ethics application status
Approved
Date submitted
5/06/2009
Date registered
18/06/2009
Date last updated
16/11/2015
Type of registration
Prospectively registered

Titles & IDs
Public title
Nicotine inhaler plus nicotine patch for smoking cessation
Scientific title
Pulmonary nicotine inhaler plus nicotine transdermal patch for 6-month smoking cessation in heavy smokers
Secondary ID [1] 279696 0
Nil
Universal Trial Number (UTN)
Trial acronym
INHALE
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Tobacco dependence 236931 0
Smoking cessation 236932 0
Condition category
Condition code
Mental Health 237290 237290 0 0
Addiction

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Nicotine pressurized metered-dose inhaler (pMDI) for 6 months plus nicotine transdermal patch for 5 months. The pMDI is a typical cannister, commonly used to deliver asthma medication. Cannisters come in 2 different doses: 100mcg, and 200mcg per puff of nicotine. Participants carry inhalers to use as needed. the nicotine patch dose will be titrated according to how many cigarettes each subjects smokes per day, as per the manufacturer's instruction - either 21,14,or7mg. During the 5th month subjects reduce by one dose step at a time over the month, so they have stopped at the end of the month. The inhaler and patches start on the same day - at Visit 1. The quit date is the date smoking ceased at the end of the four week smoking reduction phase.
Intervention code [1] 236720 0
Treatment: Drugs
Comparator / control treatment
Placebo pressurized metered-dose inhaler plus active nicotine patch both started on the same day at the baseline visit. Placebo-inhaler is identical to active inhaler except it does not contain nicotine. The inhaler is used at the discretion of the participant and the patches are used daily. Weaning from patches occurs in standard step-wise fashion as recommended by manufacturer during the 5th month of their use. Weaning from inhaler occurs in step-wise fasion (25% each week) during the 6th month of their use. Quit date is the day smoking ceased at the end of the smoking reduction month.
Control group
Placebo

Outcomes
Primary outcome [1] 238101 0
6 month prolonged abstinence (not smoking on 7 consecutive days), determined by self-report. It is not possible to biochemically verifiy this outcome.
Timepoint [1] 238101 0
6 months after scheduled quit date
Primary outcome [2] 238102 0
Sustained smoking abstinence from smoking quit date to end of the study, assessed by self-report.
Timepoint [2] 238102 0
From smoking quit date to end of the study
Secondary outcome [1] 242307 0
6 month quit rate by exhaled carbon monoxide
Timepoint [1] 242307 0
6 months post smoking cessation
Secondary outcome [2] 242308 0
6 month prolonged abstinence (not smoking on 7 days prior to the 3 month and 6 month clinic visits, biochemically verified with exhaled carbon monoxide of less than ten parts per million.
Timepoint [2] 242308 0
Between end date for nicotine inhalers and the end of follow-up (6 months post cessation)
Secondary outcome [3] 303197 0
7-day point prevalence abstinence at each follow-up and not having smoked on seven consecutive days or in two consecutive weeks between each follow-up period.
Timepoint [3] 303197 0
Follow-ups occur at 1 week after starting trial (this is within the period of smoking reduction), one day after the target quit date (self-report by phone-call); one day and one month after the target quit date (primarily by clinic visit and biochemically verified by exhaled carbon monoside <10 parts per million) but this could just be self-report by phone-call); one day and three months after target quit date (by phone-call); and one day and six months after target quit date (by phone-call).
Secondary outcome [4] 303198 0
Amount of inhaler used, and acceptability of the nicotine/placebo inhaler, measured by the modified Cigarette Evaluation Scale, and ad hoc Likert Scales; side-effects of inhaler measured by ad hoc questions (severity, duration).
Timepoint [4] 303198 0
Side-effects and inhaler use are collected at baseline, one week after starting the inhaler; the day after the target quit date, and 1, 3, and 6 months later. The Cigarette Evaluation Scale is measured at baseline, and 1 month after the target quit date

Eligibility
Key inclusion criteria
Smokers of 9 or more cigarettes per day, with a Fagerstom Test for Nicotine Dependence of 3 or more.
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Any serious medical condition, cardiovascular disease, alcohol abuse, allergy to nicotine patches, pregnancy, breastfeeding, inadequate contraception.

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)
Once subject has been found to meet inclusion criteria, the computer will generate a random number for them, which will correspond to the label on a box containing their study drug. The random number sequence used to label the boxes of active and placebo boxes will be generated by statistician, and boxes will be made up by independent staff member who will have no contact with subjects or researchers.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Generated by computer, set up by statistician.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint(s)
Safety/efficacy
Statistical methods / analysis

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] 1828 0
New Zealand
State/province [1] 1828 0
Wellington

Funding & Sponsors
Funding source category [1] 237111 0
Government body
Name [1] 237111 0
Health Research Council
Address [1] 237111 0
PO Box 5541
Auckland 1141
Country [1] 237111 0
New Zealand
Primary sponsor type
Government body
Name
Health Research Council
Address
PO Box 5541
Auckland 1141
Country
New Zealand
Secondary sponsor category [1] 4637 0
None
Name [1] 4637 0
Address [1] 4637 0
Country [1] 4637 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239212 0
Central Regional Ethics Committee
Ethics committee address [1] 239212 0
Level 2, 1-3 The Terrace, Wellington 6011, New Zealand
PO Box 5013
Ethics committee country [1] 239212 0
New Zealand
Date submitted for ethics approval [1] 239212 0
08/06/2009
Approval date [1] 239212 0
14/12/2010
Ethics approval number [1] 239212 0

Summary
Brief summary
This study aims to test whether a pulmonary nicotine inhaler plus nicotine patches can increase 6 month quit rates compared to nicotine patches plus placebo inhaler. Subjects receive 5 months of nicotine patch therapy, 6 months of nicotine inhaler therapy. Subjects reduce their smoking during the first month, after which they stop smoking completely. Quit rates are measured by self report 1 day, and 1, 3, and 6 months after the target quit date. Abstinence is verified by carbon monoxide measurements at 1 month after the target quit date.
Trial website
Trial related presentations / publications
The trial has been submitted to a journal for publication but has not yet been accepted by the journal.
Public notes

Contacts
Principal investigator
Name 29711 0
Prof Professor Julian Crane
Address 29711 0
Department of Medicine
University of Otago, Wellington
PO Box 7343
Wellington 6021
New Zealand
Country 29711 0
New Zealand
Phone 29711 0
+6449185258
Fax 29711 0
Email 29711 0
julian.crane@otago.ac.nz
Contact person for public queries
Name 12958 0
Dr Brent Caldwell
Address 12958 0
PO Box 7343 Wellington 6021
Country 12958 0
New Zealand
Phone 12958 0
+6449186041
Fax 12958 0
Email 12958 0
brent.caldwell@otago.ac.nz
Contact person for scientific queries
Name 3886 0
Dr Brent Caldwell
Address 3886 0
PO Box 7343
WELLINGTON 6242
Country 3886 0
New Zealand
Phone 3886 0
+6449186041
Fax 3886 0
Email 3886 0
brent.caldwell@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