Tiotropium for Smoking Asthmatics Study
Information source: University of Alberta
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Asthma
Intervention: tiotropium (Drug); long acting beta agonist (Drug)
Phase: Phase 4
Status: Withdrawn
Sponsored by: University of Alberta Official(s) and/or principal investigator(s): Irvin Mayers, MD, FRCPC, Principal Investigator, Affiliation: University of Alberta Darcy Marciniuk, MD, Principal Investigator, Affiliation: University of Saskatchewan Dilini Vethanayagam, MD, Principal Investigator, Affiliation: University of Alberta Harissios Vliagoftis, MD, Principal Investigator, Affiliation: Unviersity of Alberta
Summary
The study's research questions concern the appropriateness of use of tiotropium for patients
with asthma who are current smokers. It is suggested that patients with asthma who smoke,
may in fact share similarities with patients with chronic obstructive pulmonary disease
(COPD). Because of this, the study will determine whether this sub-group of patients would
in fact benefit from therapy currently approved and marketed for COPD patients.
Clinical Details
Official title: Assessing Treatment Options for Smokers With Asthma.
Study design: Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: To evaluate whether current smokers with asthma benefit from the introduction of tiotropium.
Secondary outcome: To assess whether there are specific genotypes that identify specific asthma patient populations that may benefit from this therapy.To determine if the Virtual Asthma Clinic is an acceptable tool for data collection in a clinical trial setting.
Detailed description:
The study is designed as an open label cross-over study. Ethical approval will be obtained
from both the University of Alberta Health Research Ethics Board and the University of
Saskatchewan Health Research Ethics Board.
Following informed consent, we will obtain pulmonary function testing in all subjects. If
subject is currently prescribed a long acting beta agonist (LABA) it will be stopped before
continuing with the study and the subject, as with all subjects, will be re-assessed after
two weeks. We will also measure exhaled NO (eNO) using standards established by the
American Thoracic Society. Additionally we will obtain a urine sample which will be frozen
and stored for subsequent metabolite profiling by NMR spectroscopy. Subjects currently
prescribed LABA's will have testing done two weeks after stopping medication.
We will obtain routine demographic information including age, sex, and usual asthma
medication usage. We will also obtain health related quality of life status using generic
(15D) and disease specific (Asthma Quality of Life) questionnaires. Subjects will be
instructed regarding use of peak flow meters and the typical symptoms associated with loss
of asthma control. They will be instructed regarding accessing a dedicated asthma website
(the Virtual Asthma Clinic) that incorporates the above questions. There is also a place for
subjects to enter twice daily peak flow measurements. The website is password protected and
each subject can access only their own individualized data entry pages. A research
coordinator is able to access any subject data again using a unique password. We will use
this internet-based program to monitor daily PEF, daily asthma symptoms and asthma-related
quality of life. Patients will be instructed to access the website daily and will be
re-assessed at two weeks. Subjects will be instructed to continue with their usual asthma
management and to log on to the asthma website daily to record symptoms and twice daily peak
flows. Peak flows will consist of pre-bronchodilator peak expiratory flow taken in the
morning and in the evening. Only subjects meeting criteria for well controlled asthma (GOAL
criteria) along with objective compliance with study protocols over the two weeks will then
be enrolled in the next phase of the study.
For the next two weeks of the study, subjects will be randomly allocated to take either
their regularly prescribed inhaled corticosteroid (ICS) and a long acting beta agonist
(LABA) or their regularly prescribed ICS and tiotropium. At the end of this period all
subjects will return for spirometry, urine sampling and for measurement eNO. This will be
followed by a two week wash-out period when all subjects will take only their inhaled
corticosteroid (ICS). For the subsequent two weeks the subject will take the treatment they
did not receive in the first two weeks. At the end of this period all subjects will again
return for spirometry, urine sampling and for measurement of eNO. During a fifth period of
two weeks duration, subjects will take both the LABA and tiotropium. Subjects will then
return for final measurement of spirometry, urine sampling and eNO.
Subjects showing variability of symptoms consistent with poor asthma control, will be
referred back to their treating physicians with their clinical information. All subjects
will be instructed to return to their medication regimen that was initiated by their
physician prior to the study.
If subjects experience a clinical exacerbation, they will be instructed to return to their
test site. They will be instructed to increase their controller medication and to continue
with the increased steroid phase of the study. Any subject experiencing a severe asthma
exacerbation (described below) will be withdrawn from the study. Assuming approximately 30%
severe exacerbation rate per year in this population, we would anticipate that one to two
patients would normally experience a severe exacerbation over a 10 week course. If four of
our subjects experience severe exacerbations, we will hold the trial and have an external
review of the unblinded data. This will include review of patient compliance with study
protocols. If the exacerbations are all in the tiotropium group we will stop the study. We
anticipate with the use of the on-line data collection tool (VAC), the study coordinators
will be able to see any exacerbation developing at an early point and that we will be able
to effectively intervene to prevent severe exacerbations.
A mild clinical exacerbation will be defined by any one of the following events:
1. A decrease in peak flow to less than 80% of best effort for two consecutive days.
2. An increase in reliever medication (fast acting beta agonist) by 50% over baseline
needs for two consecutive days.
3. Waking at night due to asthma on two consecutive nights. A severe exacerbation will be
defined as any need for additional medical contact for treatment of asthma (e. g.,
emergency room, walk-in clinic) or any hospital admission for asthma. The need for oral
corticosteroids will also constitute a severe exacerbation. If at any point the
subjects undergo a severe exacerbation, they will be examined by either their own
treating physician or by one of the physicians associated with this study and
appropriate escalation of treatment will be commenced. The HREB will be informed of all
severe exacerbations. The study coordinator and one of the study physicians will be
available by pager during the course of the study.
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Male or female patient with a working diagnosis of asthma by clinical presentation or
by spirometry testing results.
- Currently prescribed inhaled corticosteroids (ICS) for the treatment of asthma, and
may or may not be prescribed additional therapies for asthma.
- Is a current smoker with a minimum of a five year history of smoking.
- Provides written informed consent.
Exclusion Criteria:
- Has a diagnosis of COPD.
- Is currently enrolled in another clinical trial.
- Has any condition which, may decrease the chance of obtaining satisfactory data to
achieve the objectives of the study.
- Is unable to provide written informed consent.
Locations and Contacts
University of Alberta Hospital, Edmonton, Alberta, Canada
Royal University Hospital, Saskatoon, Saskatchewan, Canada
Additional Information
Starting date: November 2007
Last updated: August 26, 2014
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