Finding studies
Finding studies
Take this into the appointment.
Saves the questions and what to expect into your notes, next to the visit they belong to.
Alex Mann
CONTACT
Alexandre Lima, MD-PhD
CONTACT
Lead
Hvivo
With
The MAPLE study is a prospective observational study of asthma patients at the hVIVO clinical site. This study is designed as a long-term research vehicle with no limit to enrolment or any time defined end. The MAPLE study will enrol from across the spectrum of asthma severity and specifically include a strong representation of mild asthma, it will also include well controlled and less controlled, Type 2 high and low participants. Key aims will focus on the risk of progression and influence of various triggers, frequency of clinical and inflammatory risk factors (as and when participants progress from mild to more severe asthma), and assess variability and stability of respiratory and blood biomarkers and their ability to inform and predict risk (including inflammatory biomarkers, and blood cells). An initial cohort of up to at least 235 asthma patients, ≥18 years of age who attend hVIVO's clinical site, are planned to be enrolled. Longer-term clinical outcomes will be monitored for at least 5 years. Data will be collected both at yearly clinic visits as well as at planned intermediate at-home self-monitoring intervals. The study design is divided into the following study phases: 1. Baseline: Participants who have shown an interest in hVIVO will be invited to a screening visit, where where details of the study will be provided. Historical generic screening data collected through the hVIVO generic screening process may be transferred to this study after the study-specific consent form has been signed by the participant. * Study Specific Informed consent: Volunteers deemed ineligible by the Investigator during the consenting consultation will be excluded and will not proceed. If eligible, the volunteer will continue to have the following assessments and procedures performed but, may be excluded at any point should any of the procedures listed below immediately demonstrate ineligibility. * Eligibility criteria * Demographics * Risk factor assessments: smoking status and history, occupational exposure to pollutants, allergens. * Socioeconomic status/income: employment status and Work Productivity and Activity Impairment Asthma Questionnaire (WPAI). * Height, weight, BMI, waist circumference * Medical \& medication history, patient diagnosis, disease severity, age at diagnosis, personal and family history of asthma/COPD and allergies * Comorbidities (including associated medications) * Exacerbation history, asthma complications, respiratory diseases (e.g., RTI) * Asthma treatment(s) during previous 12 months - duration and posology, adherence, reasons for switching/discontinuation, satisfaction * Asthma medication assessment - inhaler technique \& inhaler training if needed * Concomitant medications * Healthcare resource utilization * Urine drugs of misuse screen * Urinalysis * Alcohol breath test * Urine pregnancy test, if applicable * Complete physical examination * Vital signs (HR, RR, SBP, DBP, SpO2) and tympanic temperature * 12-lead ECG * Fractional exhaled nitric oxide Test (FeNO) * Forced Oscillation Technique (FOT) * Peak Flow Measurement (PEF) self-test * Spirometry (including PEF) * Symptom Diary Card * Home Participant Diary Card including: Symptom diary card, PEF (self-test), asthma medications, cold perception and night disturbances and Asthma questionnaires (ACQ-6). * Asthma Control Questionnaire (ACQ-7) * Asthma Impairment and Risk Questionnaire (AIRQ) * Quality of Life Questionnaire(s) e.g. Asthma Quality of Life (AQLQ) * Hematology * Biochemistry * Blood - biomarkers * Serum - humoral immunity \& cytokine/chemokine markers * Whole blood for cell-mediated immunity * RNA PAXgene - transcriptomics * DNA PAXgene - genomics * Nasosorption - biomarkers * Nasopharyngeal swab - respiratory pathogen screen * Exhaled breath sampling method(s) (e.g. exhaled breath condensate) * Induced sputum - cells, transcriptomics and biomarkers. * Allergen skin prick test * Methacholine challenge (AHR) * Bronchodilator responsiveness For participants enrolled in to Optional Sub-studies, the following additional assessments may be performed at the screening visit and at any time on and between annual clinic visits and may occur once or more for consented participants throughout the study. * Physiological measurement devices to measure parameters such as vital signs, sleep, cough * Nasal Allergy challenge (NAC) * Bronchial Allergen challenge (BAC) * Viral challenge e.g. rhinovirus 2. Follow-up Phase including Intermittent at home assessments: Participants will attend yearly clinic follow-up visits and will be required to complete at home self-assessments at 6 monthly intervals and when experiencing symptoms of a respiratory infection. During each yearly clinic visit, procedures similar to the baseline visit will be performed as appropriate to reassess change in participants' asthma and medications. Interim at home assessments will include: * Home Participants Diary Card that includes assessments of: * Symptoms * Asthma medication usage * Peak expiratory flow (PEF) * Cold perception * Night disturbances * Asthma Control Questionnaire (ACQ-6). * Exacerbation history * Collection of respiratory samples (self-sampling) when experiencing cold-like symptoms. Participants may withdraw from the study at any time, and all efforts will be made to document any reasons for withdrawal and to complete required end-of-study assessments.
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
