None listed
Conditions
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.
Interventions
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 (Au
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.
Sponsors
Australian National University
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
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
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
Outcome results
None listed