Condition category
Respiratory
Date applied
06/09/2011
Date assigned
21/09/2011
Last edited
05/11/2012
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Lay summary under review 2

Trial website

Contact information

Type

Scientific

Primary contact

Dr Mohamed Al-Moamary

ORCID ID

Contact details

P.O 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

Ethical and IRB approval were obtained from the King Abdullah International Medical Research Center- Saudi Arabia on 5th March 2011

Study design

Randomized clinical trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below 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

Child

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

P.O 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

1. 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