Condition category
Respiratory
Date applied
06/09/2011
Date assigned
21/09/2011
Last edited
21/04/2017
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 measures

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

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

http://www.kaimrc.med.sa/

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

Results - basic reporting

Publication summary

2012 results in: http://www.ncbi.nlm.nih.gov/pubmed/22449144

Publication citations

  1. 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.

Additional files

Editorial Notes

21/04/2017: Plain English summary added.