AsthmaNCT06227793
Pragmatic Clinical Trial to Assess the Effectiveness of Pharmaceutical Intervention in Patients With Uncontrolled Asthma
A study testing pharmaceutical intervention in people with Asthma, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
Trial summary
The aim of this study is to evaluate the effectiveness of pharmaceutical intervention in controlling asthma in patients diagnosed with uncontrolled asthma. This is a pragmatic clinical trial composed of two groups - intervention (pharmaceutical monitoring) and control (without pharmaceutical monitoring). Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Asthma
- What is being tested?
- pharmaceutical intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteBrazil
- Study dates
- 14 Aug 2023to 30 Mar 2026
- Phase
- Interventional
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age from 18 to 70 years.
- Previous diagnosis of asthma according to clinical and pulmonary functional criteria, established in national and international guidelines.
- Present uncontrolled asthma as assessed by the ACT (score below 20 points) (32).
- Be undergoing outpatient treatment at the Pulmonology Service of HCPA for at least 6 months and have had at least 2 prior consultations.
- Reside in Porto Alegre or in the metropolitan region of Porto Alegre.
- Smoking index less than 10 pack-years (number of cigarettes smoked per day / 20 cigarettes x number of years of smoking).
Who cannot join
- Pregnant patients
- Chronic neurological or psychiatric diseases that prevent the execution of study procedures
- Pulmonary comorbidities such as chronic obstructive pulmonary disease, diffuse bronchiectasis, extensive sequelae of tuberculosis, diffuse pulmonary fibrosis.
- Lung neoplasms or from other sites.
- Incapacitating cardiovascular diseases
- Patients without access to WhatsApp.
Trial locations and contacts
1 site in 1 country.
Brazil1 site, 1 recruiting
- Recruiting
Hospital de Clínicas de Porto Alegre
Porto Alegre, Rio Grande do Sul, 90035903
Paulo de Tarso Roth Dalcin, Doctor
Aline de Lima Nogare, Master
About this study
The aim of this study is to evaluate the effectiveness of pharmaceutical intervention in controlling asthma in patients diagnosed with uncontrolled asthma. This is a pragmatic clinical trial composed of two groups - intervention (pharmaceutical monitoring) and control (without pharmaceutical monitoring). The study population will consist of patients with uncontrolled asthma, seen at the asthma outpatient clinic of the Hospital de Clínicas de Porto Alegre. Patients who agree to participate in the study will be randomized to the control group (managed by the specialized outpatient medical team) and the intervention group (in addition to management by the specialized medical team, they will be referred for pharmaceutical monitoring at the Clinical Research Center of the Hospital de Clínicas de Porto Alegre). The primary outcome of the study will be the proportion of patients with uncontrolled asthma who achieve an ACT > 20 after a systematic educational intervention, guided by a pharmaceutical professional, compared to a group that does not receive this type of intervention.
Read the detailed description
Asthma is a heterogeneous disease, typically characterized by chronic inflammation of the airways. Uncontrolled asthma is a condition that can directly impact patients' quality of life and be associated with non-adherence to treatment and errors in inhalation technique. It is known that pharmaceutical monitoring contributes positively to asthma control. Thus, the aim of this study is to evaluate the effectiveness of pharmaceutical intervention in controlling asthma in patients diagnosed with uncontrolled asthma. This is a pragmatic clinical trial composed of two groups - intervention (pharmaceutical monitoring) and control (without pharmaceutical monitoring). The study population will consist of patients with uncontrolled asthma, seen at the asthma outpatient clinic of the Hospital de Clínicas de Porto Alegre. Patients who agree to participate in the study will be randomized to the control group (managed by the specialized outpatient medical team) and the intervention group (in addition to management by the specialized medical team, they will be referred for pharmaceutical monitoring at the Clinical Research Center of the Hospital de Clínicas de Porto Alegre). For both groups, the Asthma Control Test (ACT), the standardized Asthma Quality of Life Questionnaire (AQLQ(S)), and treatment adherence questionnaire will be administered by phone at the beginning of month 1 and at the end of month 3, by a blinded researcher in the study. The primary outcome of the study will be the proportion of patients with uncontrolled asthma who achieve an ACT > 20 after a systematic educational intervention, guided by a pharmaceutical professional, compared to a group that does not receive this type of intervention. To achieve this, a sample size of 50 individuals (25 for each group) was calculated to test for a difference between the percentages of controlled asthma (ACT > 20) at the end of 3 months between the Pharmaceutical Intervention and Control groups. With an additional 30% for possible losses and refusals, this number should be 56. The calculation considered a power of 80%, a significance level of 5%, and percentages of 50% and 10%, respectively. This study is expected to generate scientific evidence on the effectiveness of pharmaceutical intervention in asthma control and guide public policies within the Unified Health System (SUS).
- Conditions
- Asthma
- Being tested
- pharmaceutical intervention
- Medical subject headings
- Asthma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
pharmaceutical interventionBehavioural
Individuals randomized to the intervention group will undergo monthly pharmaceutical consultations for health education, initiated after randomization. There will be three in-person consultations, starting in month 1 with monthly spacing, scheduled by the pharmacist in the office, except for the first consultation, which will be scheduled by the pharmacist over the phone after randomization. These consultations will be part of the intervention study's educational process and will take place between the initial and final assessments. The educational process scripts for each consultation include a pharmaceutical follow-up form and an inhalation technique assessment form. Once the consultation is completed, the patient will also receive, via WhatsApp and/or email according to their preference, an educational video demonstrating the step-by-step inhalation technique based on their prescribed treatment.
| Study group | Role | What they receive |
|---|---|---|
| intervention | Experimental | With health education Receives: Behavioral: pharmaceutical intervention |
| control | No intervention | Without health education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Asthma control
The degree of asthma control will be determined according to the Asthma Control Test (ACT). The questionnaire score ranges from 5 to 25 (higher scores indicate better control), with a score of 25 points expressing the best possible control. Scores from 20 to 25 are classified as controlled; 16-19 as not well controlled; and 5-15 as very poorly controlled asthma. The ACT consists of four questions about symptoms/relief and self-assessment of control by the patient. A clinically important minimum difference of 3 points is considered.
Measured: 3 years
Secondary outcomes (6)
Degree of adherence to treatment
Treatment adherence will be measured through self-reported adherence, using a questionnaire employed in a study involving asthmatic patients as a reference. The adherence score will be defined as a score above 5 points or below 5 points. High adherence will be indicated when the reported use of devices containing corticosteroids is 5 or more times per week, while low adherence will be considered when it is less than 5 times per week.
Measured: 3 years
Asthma Quality of Life Questionnaire
The quality of life will be assessed using The Asthma Quality of Life Questionnaire (AQLQ). The overall score of the questionnaire is the arithmetic mean of all items, with a minimum score of 1 and a maximum of 7 points. Higher scores would indicate better quality of life in relation to asthma.
Measured: 3 years
Lung function (spirometry)
The spirometry used for the diagnosis of asthma will be obtained through a review of the patient's medical records or by query. The baseline spirometry for the study will be the one conducted during the routine medical consultation, also obtained through a review of medical records or by query. The study will include a spirometry test at the end of the 3 months, after the pharmaceutical interventions, to be requested by the research team. Spirometry tests are routinely performed in the Pulmonary Physiology Unit of the Pneumology Service at HCPA.
Pneumologia do HCPA.
Measured: 3 years
Rates of exacerbations requiring oral corticosteroid use
Clinical and demographic data will be recorded upon request through queries. For those that cannot be collected through queries, the information will be obtained directly from the medical records or gathered during the initial evaluation.
Measured: 3 years
Emergency room visits for asthma
Clinical and demographic data will be recorded upon request through queries. For those that cannot be collected through queries, the information will be obtained directly from the medical records or gathered during the initial evaluation.
Measured: 3 years
Hospital admissions due to asthma
Clinical and demographic data will be recorded upon request through queries. For those that cannot be collected through queries, the information will be obtained directly from the medical records or gathered during the initial evaluation.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2024
- Study start14 Aug 2023
- Primary completion31 Aug 2025 (estimated)
- Study completion30 Mar 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AsthmaStudies of the same condition, open and under way.
- More trials run by Hospital de Clinicas de Porto AlegreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital de Clinicas de Porto Alegre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Paulo Dalcin, Principal investigator, Hospital Clínicas de Porto Alegre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06227793
- Sponsor's protocol ID
- 20230013
- Status last verified
- Jan 2024
- First submitted
- 18 Jan 2024
- Last updated
- 29 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pragmatic Clinical Trial to Assess the Effectiveness of Pharmaceutical Intervention in Patients With Uncontrolled Asthma
- ClinicalTrials.gov ID
- NCT06227793
- Acronym / sponsor ID
- 20230013
- Conditions
- Asthma
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Hospital de Clinicas de Porto AlegreUniversity, hospital or other
- Study start
- 14 Aug 2023 (actual)
- Primary completion
- 31 Aug 2025 (estimated)
- Study completion
- 30 Mar 2026 (estimated)
- First posted
- 29 Jan 2024 (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.
The aim of this study is to evaluate the effectiveness of pharmaceutical intervention in controlling asthma in patients diagnosed with uncontrolled asthma. This is a pragmatic clinical trial composed of two groups - intervention (pharmaceutical monitoring) and control (without pharmaceutical monitoring). The study population will consist of patients with uncontrolled asthma, seen at the asthma outpatient clinic of the Hospital de Clínicas de Porto Alegre. Patients who agree to participate in the study will be randomized to the control group (managed by the specialized outpatient medical team) and the intervention group (in addition to management by the specialized medical team, they will be referred for pharmaceutical monitoring at the Clinical Research Center of the Hospital de Clínicas de Porto Alegre). The primary outcome of the study will be the proportion of patients with uncontrolled asthma who achieve an ACT > 20 after a systematic educational intervention, guided by a pharmaceutical professional, compared to a group that does not receive this type of intervention.
Detailed description
Asthma is a heterogeneous disease, typically characterized by chronic inflammation of the airways. Uncontrolled asthma is a condition that can directly impact patients' quality of life and be associated with non-adherence to treatment and errors in inhalation technique. It is known that pharmaceutical monitoring contributes positively to asthma control. Thus, the aim of this study is to evaluate the effectiveness of pharmaceutical intervention in controlling asthma in patients diagnosed with uncontrolled asthma. This is a pragmatic clinical trial composed of two groups - intervention (pharmaceutical monitoring) and control (without pharmaceutical monitoring). The study population will consist of patients with uncontrolled asthma, seen at the asthma outpatient clinic of the Hospital de Clínicas de Porto Alegre. Patients who agree to participate in the study will be randomized to the control group (managed by the specialized outpatient medical team) and the intervention group (in addition to management by the specialized medical team, they will be referred for pharmaceutical monitoring at the Clinical Research Center of the Hospital de Clínicas de Porto Alegre). For both groups, the Asthma Control Test (ACT), the standardized Asthma Quality of Life Questionnaire (AQLQ(S)), and treatment adherence questionnaire will be administered by phone at the beginning of month 1 and at the end of month 3, by a blinded researcher in the study. The primary outcome of the study will be the proportion of patients with uncontrolled asthma who achieve an ACT > 20 after a systematic educational intervention, guided by a pharmaceutical professional, compared to a group that does not receive this type of intervention. To achieve this, a sample size of 50 individuals (25 for each group) was calculated to test for a difference between the percentages of controlled asthma (ACT > 20) at the end of 3 months between the Pharmaceutical Intervention and Control groups. With an additional 30% for possible losses and refusals, this number should be 56. The calculation considered a power of 80%, a significance level of 5%, and percentages of 50% and 10%, respectively. This study is expected to generate scientific evidence on the effectiveness of pharmaceutical intervention in asthma control and guide public policies within the Unified Health System (SUS).
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intervention | Experimental | Behavioral: pharmaceutical interventionWith health education |
| control | No intervention | –Without health education |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age from 18 to 70 years.
- Previous diagnosis of asthma according to clinical and pulmonary functional criteria, established in national and international guidelines.
- Present uncontrolled asthma as assessed by the ACT (score below 20 points) (32).
- Be undergoing outpatient treatment at the Pulmonology Service of HCPA for at least 6 months and have had at least 2 prior consultations.
- Reside in Porto Alegre or in the metropolitan region of Porto Alegre.
Key exclusion criteria (6 listed)
- Pregnant patients
- Chronic neurological or psychiatric diseases that prevent the execution of study procedures
- Pulmonary comorbidities such as chronic obstructive pulmonary disease, diffuse bronchiectasis, extensive sequelae of tuberculosis, diffuse pulmonary fibrosis.
- Lung neoplasms or from other sites.
- Incapacitating cardiovascular diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| pharmaceutical interventionIndividuals randomized to the intervention group will undergo monthly pharmaceutical consultations for health education, initiated after randomization. There will be three in-person consultations, starting in month 1 with monthly spacing, scheduled by the pharmacist in the office, except for the first consultation, which will be scheduled by the pharmacist over the phone after randomization. These consultations will be part of the intervention study's educational process and will take place between the initial and final assessments. The educational process scripts for each consultation include a pharmaceutical follow-up form and an inhalation technique assessment form. Once the consultation is completed, the patient will also receive, via WhatsApp and/or email according to their preference, an educational video demonstrating the step-by-step inhalation technique based on their prescribed treatment. | Behavioural | intervention |
Primary outcome
Asthma control
Time frame: 3 years
The degree of asthma control will be determined according to the Asthma Control Test (ACT). The questionnaire score ranges from 5 to 25 (higher scores indicate better control), with a score of 25 points expressing the best possible control. Scores from 20 to 25 are classified as controlled; 16-19 as not well controlled; and 5-15 as very poorly controlled asthma. The ACT consists of four questions about symptoms/relief and self-assessment of control by the patient. A clinically important minimum difference of 3 points is considered.
6 secondary outcomes
Degree of adherence to treatment
Time frame: 3 years
Asthma Quality of Life Questionnaire
Time frame: 3 years
Lung function (spirometry)
Time frame: 3 years
Rates of exacerbations requiring oral corticosteroid use
Time frame: 3 years
Emergency room visits for asthma
Time frame: 3 years
Hospital admissions due to asthma
Time frame: 3 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2024.
- Individual participant dataSharing planned: No
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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.
Paulo Dalcin principal investigator
Hospital Clínicas de Porto Alegre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing pharmaceutical intervention in people with Asthma, run by Hospital de Clinicas de Porto Alegre at 1 site in Brazil.
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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Paulo Dalcin, Doctor (555133422439, pdalcin@hcpa.edu.br), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Asthma control (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 29 Jan 2024.