Plain English Summary
Background and study aims
Asthma is a common lung condition that causes occasional breathing difficulties. The Asthma Control Test provides asthma sufferers and their doctors and nurses with a score to help them determine the level of treatment required. The aim of this study is to assess the responsiveness of the Asthma Control Test to detect changes in patients’ clinical status at the start of treatment in a primary care (GP) setting.
Who can participate?
Patients aged over 12 with asthma
What does the study involve?
At the first visit, a nurse performs basic vital signs screening, measures breathing, completes a data collection form (disease duration, education level, breathing symptoms, smoking), and asks the participant to complete the Asthma Control Test. Participants are then randomly allocated to receive their initial treatment based on either the Saudi Initiative for Asthma (SINA) approach or the Global Initiative for Asthma (GINA) approach. The recommended steps of asthma treatment are as follows:
Step 1: rapid onset B2 agonist (reliever) inhaler as needed
Step 2: low doses inhaled corticosteroids (preventer inhaler)
Step 3: low-medium dose inhaled corticosteroids with long-acting bronchodilator (long-acting reliever inhaler)
Participants in the SINA group receive their initial treatment based on the result of the Asthma Control Test, starting at step 1 when the score is 20 or over, step 2 when the score is 16-19, and step 3 when the score is less than 16. The GINA group patients start on step 2 when they have persistent asthma symptoms or step 3 when they have severely uncontrolled disease. Patients receive an education session explaining the nature of asthma, the importance of compliance with treatment, the features of an asthma attack, and inhaler technique. A follow-up visit is offered to the patients 4 weeks later to assess their level of asthma control using the Asthma Control Test. Between the visits, participants are advised to visit their doctor or the emergency department if they feel that their asthma is not controlled.
What are the possible benefits and risks of participating?
Patients will receive standard treatment, close follow-up and education. There are no known side effects of taking part in the study.
Where is the study run from?
King Abdullah International Medical Research Center (Saudi Arabia)
When is the study starting and how long is it expected to run for?
September to October 2011
Who is funding the study?
King Abdullah International Medical Research Center (Saudi Arabia)
Who is the main contact?
Dr Mohamed Al-Moamary
almoamary@ngha.med.sa
Trial website
Contact information
Type
Scientific
Primary contact
Dr Mohamed Al-Moamary
ORCID ID
Contact details
PO Box 84252
Riyadh
11671
Saudi Arabia
+966 (0)50 545 9610
almoamary@ngha.med.sa
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
RC10/091
Study information
Scientific title
Utilization of the Asthma Control Test at the initiation of therapy for patients with asthma: a randomized controlled trial
Acronym
UACTA
Study hypothesis
The global initiative for asthma have hypothesized that initiation of asthma therapy is based on physician judgment. We challenged that by utilizing the asthma control test at the initiation of therapy.
Ethics approval
King Abdullah International Medical Research Center, 05/03/2011
Study design
Randomized clinical trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
GP practices
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Asthma
Intervention
Patients will be randomized to receive their initial treatment based on either the Saudi Initiative for Asthma (SINA) Approach (Group A) or the Global Initiative for Asthma (GINA) approach (group B).
At the initial visit, the nurse will perform the basic vital signs screening, measures forced expiratory volumes in one second (FEV1) and peak expiratory flow, fill the data collection form (Disease duration, education level, respiratory symptoms, exacerbation and admissions, smoking, and pulmonary function tests), and ask the patients to fill the baseline ACT. Patients will be assigned to either group A or B, based on a simple random allocation. Randomization will be carried out by a biostatistician, and the allocation treatment will be concealed in a closed opaque envelope.
The primary care physicians will be trained by the authors to either the SINA or GINA approach. Those who will follow the SINA approach will base their initial treatment on the result of ACT where they will receive treatment at step 1,2, or 3. While those patients allocated to group B will be commenced on step 2 based on GINA when they have persistent asthma symptoms and step 3 when they have severely uncontrolled disease. Patients will receive an education session for their asthma that consist of: explaining the nature of disease, importance of compliance, features of asthma attack, and inhalers technique.
Step1: Rapid onset B2 agonist inhaler on as needed bases.
Step 2: Inhaled corticosteroids low doses.
Step 3: Low-medium dose inhaled corticosteroids with long acting bronchodilator.
A follow-up visit will be offered to the patients 4 weeks later to assess their level of asthma control by ACT. Between the visits, patients will be advised to come back for their physicians or visit Emergency department if they feel that their asthma is not controlled.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
1. Step up or down of therapy
2. Change in asthma control test (ACT)
3. Change in peak expiratory flow (PEF)
Measured at initiation visit then follow-up visit in 4 weeks time
Secondary outcome measures
Change in forced expiratory volume in 1 sec (FEV1), measured at initiation visit then follow-up visit in 4 weeks time
Overall trial start date
10/09/2011
Overall trial end date
25/10/2011
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Age above 12 years with the diagnosis of asthma
2. Literate patient
3. No controller therapy for 2 months
Participant type
Patient
Age group
Mixed
Gender
Both
Target number of participants
45-50 patients in each arm i.e., GINA arm and SINA arm
Participant exclusion criteria
Use of controller therapy for 2 months
Recruitment start date
10/09/2011
Recruitment end date
25/10/2011
Locations
Countries of recruitment
Saudi Arabia
Trial participating centre
PO Box 84252
Riyadh
11671
Saudi Arabia
Sponsor information
Organisation
King Abdullah International Medical Research Center (Saudi Arabia)
Sponsor details
Shiekh Jaber Street
Riyadh
11426
Saudi Arabia
+966 (0)1 801 1111
kaimrc@ngha.med.sa
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Hospital/treatment centre
Funder name
King Abdullah International Medical Research Center (Saudi Arabia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22449144
Publication citations
-
Results
Al Moamary MS, Al-Kordi AG, Al Ghobain MO, Tamim HM, Utilization and responsiveness of the asthma control test (ACT) at the initiation of therapy for patients with asthma: a randomized controlled trial., BMC Pulm Med, 2012, 12, 14, doi: 10.1186/1471-2466-12-14.