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Trial registered on ANZCTR


Registration number
ACTRN12610000807055
Ethics application status
Approved
Date submitted
25/09/2010
Date registered
27/09/2010
Date last updated
27/09/2010
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot Study of Outcome and Goal Oriented Monitoring of Asthma in General Practice
Scientific title
Pilot Study of Outcome and Goal Oriented Monitoring of Asthma in Adult Patients in General Practice
Secondary ID [1] 252761 0
none
Universal Trial Number (UTN)
Trial acronym
OGOMIA Pilot Study
Linked study record

Health condition
Health condition(s) or problem(s) studied:
asthma 3898 0
Condition category
Condition code
Respiratory 4096 4096 0 0
Asthma

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Each visit is expected to take approximately 60 to 90 minutes. There are 3 visits over a period of 12 weeks with 6 weeks between visits. At each visit, participants are required to complete the Asthma Quality of Life Questionnaire, the Asthma Control Questionnaire as well as a symptom score questionnaire - these questionnaires are validated. At each visit, measurement of lung function via spirometry as well as an inhaled mannitol challenge test of airway hyperresponsiveness will be performed (Australian Register of Therapeutic Goods registration number for the mannitol challenge test = AUSTR 116832). Dependent on the results of spirometry and the inhaled mannitol challenge test, variations may be made to the dose and type of inhaled asthma medications. At Visit 2 and Visit 3, subjects who have been issued with a Smartinhaler (trademark) device to measure inhaled corticosteroid use will have the data from this device downloaded to a computer. At each visit subjects will be encouraged to remain adherent to their dose of inhaled corticosteroid and to state a personal goal for their asthma treatment.
Intervention code [1] 3623 0
Treatment: Drugs
Comparator / control treatment
No comparator
Control group
Uncontrolled

Outcomes
Primary outcome [1] 4990 0
This is a pilot study into the feasibility and acceptability of outcome and goal orientated monitoring of inhaled corticosteroids in asthma within the general practice context using airway hyperresponsiveness challenge testing. This study is not powered to detect any outcome. The study will be used as the basis for future study designs. The number of patients who participate as well as their impressions of acceptability of the process will form the primary outcome. This pilot will assess the feasibility of implementing this method of managing asthma in general practice - this will be measured by the response rates as well as qualitative data from general practitioners and practice nurses.
Timepoint [1] 4990 0
This pilot study has 3 visits in total each of which are 6 weeks apart.
Secondary outcome [1] 8426 0
None
Timepoint [1] 8426 0
None

Eligibility
Key inclusion criteria
Males or females aged 18 to 70 years
Confirmed diagnosis of asthma (By a general practitioner or specialist and taking inhaled corticosteroid medication)
Baseline Forced Expiratory Volume in 1 Second (FEV1) greater than 70% of predicted
Able to perform spirometry in a reproducible manner
Less than 10 pack year history of smoking in reformed smokers
Signed written informed consent to participate in the study
Females of childbearing potential must be using an effective form of contraception during the study
Residing in the community
Able to read and understand English (for questionnaires)
Ambulatory or ambulatory aided (walking frame/stick)
Compliant with the requirements of the study
Minimum age
18 Years
Maximum age
70 Years
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Subjects aged less than 18 years or 71 years and above
Investigators, site personnel directly affiliated with this study, and their immediate families
Severe asthma defined by an admission to an intensive care unit (ICU) in the last 6 months
Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) with no significant reversibility
Diagnosis of bronchiectasis or cystic fibrosis
Inpatients of a hospital or nursing home
Significant active cerebrovascular, cardiovascular, gastrointestinal (including cirrhosis), haematological, renal, or endocrine, disease
Known aortic or cerebral aneurysm
Uncontrolled hypertension (greater than 180/100mmHg)
Myocardial infarction or cerebral vascular accident in the six months prior to enrollment
Major surgery or cataract surgery within the last 6 months
Subjects requiring total nursing care or confined to a wheelchair
Significant history of drug or alcohol use
Any mental health disorder which would make participation in the clinical trial problematic
Participation in any other clinical trial or investigative drug study within the last 4 weeks prior to the screening visit
Current cigarette smoking or history of smoking within the 6 months prior to enrollment in the study
Any other medical or social condition which in the opinion of the investigator would impair the ability of the subject to participate in this study
Females who are pregnant or breast feeding
Upper or lower respiratory tract infection within the 4 weeks prior to the screening visit
Intolerance/allergy to mannitol (Aridol (trademark)) or beta agonists

Study design
Purpose of the study
Treatment
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
Single group
Other design features
Phase
Not Applicable
Type of endpoint(s)
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 in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 4089 0
Government body
Name [1] 4089 0
General Practice Education and Training Ltd (GPET)
Address [1] 4089 0
GPO Box 2914
Canberra ACT 2601
Country [1] 4089 0
Australia
Primary sponsor type
University
Name
Australian National University
Address
CANBERRA ACT 0200
Country
Australia
Secondary sponsor category [1] 3682 0
Individual
Name [1] 3682 0
Professor Nicholas Glasgow
Address [1] 3682 0
Medical School
Frank Fenner Building 42
The Australian National University
CANBERRA ACT 0200
Country [1] 3682 0
Australia
Other collaborator category [1] 251533 0
Individual
Name [1] 251533 0
Dr John D Brannan
Address [1] 251533 0
Department of Respiratory and Sleep Medicine, 11 West, Royal Prince Alfred Hospital, Missenden Road, CAMPERDOWN, NSW, 2050
Country [1] 251533 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 6160 0
ACT Health Human Research Ethics Committee
Ethics committee address [1] 6160 0
Level 3, 11 Moore Street
Canberra City, ACT, 2601
Ethics committee country [1] 6160 0
Australia
Date submitted for ethics approval [1] 6160 0
Approval date [1] 6160 0
09/10/2008
Ethics approval number [1] 6160 0
ETH.8/08.759
Ethics committee name [2] 259752 0
Australian National University Human Research Ethics Committee
Ethics committee address [2] 259752 0
Office of Research Integrity
Research Office
Chancelry Building 10B
The Australian National University
Canberra, ACT 0200
Ethics committee country [2] 259752 0
Australia
Date submitted for ethics approval [2] 259752 0
16/10/2008
Approval date [2] 259752 0
28/10/2008
Ethics approval number [2] 259752 0
2008/497

Summary
Brief summary
This study aims to find out whether a method of monitoring asthma with the potential to improve adherence and control is feasible and acceptable in the general practice environment. It is hoped that this study will lead to improvements in asthma control.

Prospective asthmatic patients will be invited to participate in the study and those who meet the eligibility criteria will proceed in the study. The study will involve 3 visits of no more 2 hours duration, each visit being 6 weeks apart. There will be some flexibility in that the visits can occur 2 weekdays before or after the exact scheduled date. See Attachment 1 for the study timeline.

Subjects will be seen by Dr James Turton (study coordinator) who will conduct all clinical visits. Subjects will have their lung function tested and will be tested for asthma using an inhaled mannitol challenge test (Aridol (trademark)). During clinic visits, subjects will complete questionnaires relating to asthma quality of life, control and symptoms as well as being asked about their experiences during the testing process.

In order to measure whether the subjects are using their inhaled medication as prescribed, subjects who use “puffers” (pressurised metered dose inhaler) will be issued with an electronic dose counter (Smartinhaler (trademark)). The Smartinhaler (trademark) device will time and date stamp each actuation – subjects will be informed of this feature of the device. Those who use an alternative dry powder inhaler type of medication will have the built-in dose counter on such devices checked at each visit.

As this is a feasibility and acceptability study, both general practitioners and practice nurses will be invited to give their impressions of the monitoring process in brief semistructured interviews.

The information obtained in the pilot study will inform the development of a formal research protocol to test this intervention.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29080 0
Address 29080 0
Country 29080 0
Phone 29080 0
Fax 29080 0
Email 29080 0
Contact person for public queries
Name 12237 0
Dr James Turton
Address 12237 0
School of General Practice, Rural & Indigenous Health
ANU Medical School Bldg 4, Level 2
The Canberra Hospital Campus
PO Box 11
WODEN ACT 2606
Country 12237 0
Australia
Phone 12237 0
+61 2 6244 2946
Fax 12237 0
+61 2 6244 4105
Email 12237 0
james.turton@anu.edu.au
Contact person for scientific queries
Name 3165 0
Dr James Turton
Address 3165 0
School of General Practice, Rural & Indigenous Health
ANU Medical School Bldg 4, Level 2
The Canberra Hospital Campus
PO Box 11
WODEN ACT 2606
Country 3165 0
Australia
Phone 3165 0
+61 2 6244 2946
Fax 3165 0
+61 2 6244 4105
Email 3165 0
james.turton@anu.edu.au

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