Asthma Control LevelASCOPENCT03804632
Assessment of Asthma Control Level in Primary Care Setting in Malaysia
An observational study of Asthma Control Level, run by AstraZeneca at 10 sites in Malaysia.
Trial summary
A prospective observational multi center study to assess the level of asthma control at Primary Care Setting; government health clinics (Klinik Kesihatan) in Malaysia. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of asthma control and the potential risk… Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Asthma Control Level
- How many people
- 1,011 participants
- Where
- 10 sitesMalaysia
- Study dates
- 23 Oct 2017to 6 Jun 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Outpatients seen and treated by health care providers at government health clinics.
Who may be able to join
- Malaysians who have been diagnosed with Asthma by a physician verified by an investigator and seen at government health clinic (Klinik Kesihatan) from October - December 2017
- Be at least 18 years of age
Who cannot join
- Clinical features suggesting emphysema or chronic bronchitis and other chronic lung diagnosis
- Pregnancy
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Malaysia10 sites
Research Site
Asajaya, Sarawak
Research Site
Bandar Permaisuri, Terengganu
Research Site
Banting, Selangor
Research Site
George Town, Pulau Pinang
Research Site
Kota Kinabalu, Sabah
Research Site
Kuala Terengganu, Terengganu
Research Site
Pantai Remis, Perak
Research Site
Port Dickson, Negeri Sembilan
Research Site
Rawang, Selangor
Research Site
Seremban, Negeri Sembilan
About this study
Official title: A Prospective Observational Multi Center Study to Assess the Level of Asthma Control at Government Health Clinics (Klinik Kesihatan) in Malaysia.
A prospective observational multi center study to assess the level of asthma control at Primary Care Setting; government health clinics (Klinik Kesihatan) in Malaysia. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of asthma control and the potential risk factors for uncontrolled disease in asthma patients treated at government health clinics.
Read the detailed description
Despite the availability of GINA global guideline on asthma management which is widely referred by health care providers in Malaysia, the control of asthma is still a critical challenge. According to National Health and Morbidity Survey 2011, the prevalence of asthma in Malaysia is at 6.3%. Based on self-rated health status, 5.5% of patients were reported to be in good health whereas 9.9% reported poor health status although medications such as inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) are widely available for effective asthma management. There is limited data to assess the level of asthma control at the Primary Care Setting in Malaysia which includes current clinical manifestation and future risk of exacerbation. Given the lack of data on Asthma control level, the awareness on the current disease control level will assist to properly characterise the patients based on GINA control level thus leading to appropriate diagnosis and treatment. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients.
- Conditions
- Asthma Control Level
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| GINA-defined clinical diagnosis of Asthma | All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from October to December 2017 with age 18 and above |
What is being measured
The primary outcome is the main question the study is designed to answer.
Level of GINA-defined asthma control
GINA-defined asthma control: According to clinical characteristics that include daytime symptoms, limitations of activity, nocturnal symptoms/awakening, need for reliever/rescue treatment. Patient's are classified as controlled, partially controlled or uncontrolled.
Measured: up to 8 months
Secondary outcomes (3)
Types of medication prescribed for asthma control
Pharmacological management used for asthma control
Measured: up to 8 months
Asthma control level
Asthma control is evaluated by patients' self-completion of the Asthma Control Test (ACT). The ACT is a reliable, valid tool that helps physicians identify patients with uncontrolled asthma in a clinical setting. The questionnaire assesses the frequency of asthma symptoms and patients' own perception of asthma control during the previous 4 weeks. Based on the sum of scores, complete asthma control (25 points), well-controlled asthma (20-24 points) or no asthma control (≤19 points) is revealed.
Measured: up to 8 months
Adherence level in patients with inhalers
Adherence level measured by Malaysia Medication Adherence Scale (MALMAS)
The first item of the MALMAS has five responses: (1) All the time, (2) Often, (3) Sometimes, (4) Rarely and (5) Never.
The remaining seven items have a dichotomous response of "Yes" or "No". The responses in the MALMAS were scored based on the MMAS-8 where the total score ranged from 0 to 8. Both instruments categorized medication adherence based on the total scores obtained: low adherence (total score<6), medium adherence (6 to < 8) and high adherence (total score = 8)
Measured: up to 8 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jan 2019
- Study start23 Oct 2017
- Primary completion6 Jun 2018
- Study completion6 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Asthma Control LevelStudies of the same condition, open and under way.
- More trials run by AstraZenecaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 1,011 participants (actual)
Sponsor and investigators
- Lead sponsor
- AstraZeneca
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03804632
- Sponsor's protocol ID
- D2287R00120
- Acronym
- ASCOPE
- Status last verified
- May 2019
- First submitted
- 14 Jan 2019
- Last updated
- 31 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Mohd Isa NA, Cheng CL, Nasir NH, Naidu V, Gopal VR, Alexander AK. Asthma control and asthma treatment adherence in primary care: results from the prospective, multicentre, non-interventional, observational cohort ASCOPE study in Malaysia. Med J Malaysia. 2020 Jul;75(4):331-337.
PubMed 32723990
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Observational Multi Center Study to Assess the Level of Asthma Control at Government Health Clinics (Klinik Kesihatan) in Malaysia.
- ClinicalTrials.gov ID
- NCT03804632
- Acronym / sponsor ID
- ASCOPE / D2287R00120
- Conditions
- Asthma Control Level
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,011 participants (actual)
- Lead sponsor
- AstraZenecaIndustry (pharma, biotech, devices)
- Study start
- 23 Oct 2017 (actual)
- Primary completion
- 6 Jun 2018 (actual)
- Study completion
- 6 Jun 2018 (actual)
- First posted
- 15 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A prospective observational multi center study to assess the level of asthma control at Primary Care Setting; government health clinics (Klinik Kesihatan) in Malaysia. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of asthma control and the potential risk factors for uncontrolled disease in asthma patients treated at government health clinics.
Detailed description
Despite the availability of GINA global guideline on asthma management which is widely referred by health care providers in Malaysia, the control of asthma is still a critical challenge. According to National Health and Morbidity Survey 2011, the prevalence of asthma in Malaysia is at 6.3%. Based on self-rated health status, 5.5% of patients were reported to be in good health whereas 9.9% reported poor health status although medications such as inhaled corticosteroids (ICS) and long-acting beta agonists (LABA) are widely available for effective asthma management. There is limited data to assess the level of asthma control at the Primary Care Setting in Malaysia which includes current clinical manifestation and future risk of exacerbation. Given the lack of data on Asthma control level, the awareness on the current disease control level will assist to properly characterise the patients based on GINA control level thus leading to appropriate diagnosis and treatment. The specific objective of the study is to assess, in real-life clinical practice in Malaysia, the level of GINA-defined asthma control and the potential risk factors for uncontrolled disease in asthma patients.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GINA-defined clinical diagnosis of Asthma | – | –All patients with GINA-defined clinical diagnosis of Asthma seen at respiratory clinic from October to December 2017 with age 18 and above |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Outpatients seen and treated by health care providers at government health clinics.
Key inclusion criteria (2 listed)
- Malaysians who have been diagnosed with Asthma by a physician verified by an investigator and seen at government health clinic (Klinik Kesihatan) from October - December 2017
- Be at least 18 years of age
Key exclusion criteria (2 listed)
- Clinical features suggesting emphysema or chronic bronchitis and other chronic lung diagnosis
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Level of GINA-defined asthma control
Time frame: up to 8 months
GINA-defined asthma control: According to clinical characteristics that include daytime symptoms, limitations of activity, nocturnal symptoms/awakening, need for reliever/rescue treatment. Patient's are classified as controlled, partially controlled or uncontrolled.
3 secondary outcomes
Types of medication prescribed for asthma control
Time frame: up to 8 months
Asthma control level
Time frame: up to 8 months
Adherence level in patients with inhalers
Time frame: up to 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2019.
- Derived from this study: PubMed 32723990Mohd Isa NA, Cheng CL, Nasir NH, Naidu V, Gopal VR, Alexander AK. Asthma control and asthma treatment adherence in primary care: results from the prospective, multicentre, non-interventional, observational cohort ASCOPE study in Malaysia. Med J Malaysia. 2020 Jul;75(4):331-337.
- CSR SynopsisLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Asthma Control Level, run by AstraZeneca at 10 sites in Malaysia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Malaysia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Level of GINA-defined asthma control (time frame: up to 8 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03804632, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2019.