Evaluating the effectiveness of pharmaceutical intervention for uncontrolled asthma
Pragmatic Clinical Trial to Assess the Effectiveness of Pharmaceutical Intervention in Patients With Uncontrolled Asthma
This study is testing if adding extra medication support to regular asthma care can help people with uncontrolled asthma breathe better and improve their quality of life.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 76 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Hospital de Clinicas de Porto Alegre Academic / other |
| Locations | 1 site (Porto Alegre, Rio Grande Do Sul) |
| Trial ID | NCT06227793 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to assess the effectiveness of pharmaceutical intervention in managing uncontrolled asthma in patients. It involves two groups: one receiving pharmaceutical monitoring in addition to standard care, and a control group receiving standard care alone. Participants will be randomized and monitored over three months, with outcomes measured using the Asthma Control Test and quality of life questionnaires. The study is conducted at the Hospital de Clínicas de Porto Alegre, focusing on improving asthma control through targeted pharmaceutical support.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with a diagnosis of uncontrolled asthma who have been receiving outpatient treatment for at least six months.
Not a fit: Patients with chronic pulmonary comorbidities or significant cardiovascular diseases may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve asthma control and quality of life for patients with uncontrolled asthma.
How similar studies have performed: Previous studies have indicated that pharmaceutical monitoring can positively impact asthma control, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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). Exclusion Criteria: * 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.
Where this trial is running
Porto Alegre, Rio Grande Do Sul
- Hospital de Clínicas de Porto Alegre — Porto Alegre, Rio Grande Do Sul, Brazil (Recruiting)
Study contacts
- Principal investigator: Paulo Dalcin — Hospital Clínicas de Porto Alegre
- Study coordinator: Paulo Dalcin, Doctor
- Email: pdalcin@hcpa.edu.br
- Phone: 555133422439
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.