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Completed

NCT Number: NCT04598555

Study on Patterns of Care in Mild Asthmatic Patients

The PRIME study is an observational, Real World Evidence study designed to collect the type of treatments that are currently prescribed to patients with mild asthma and to collect relevant clinical data that could reflect the control of the disease over a 6-month observational period according to the standard clinical practice.

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Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

DE-008 Lungenarztpraxis Hellersdorf, Berlin, Germany

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About this study

Outpatients attending the hospital clinics/study centres will be recruited. Patients with mild asthma treated by Step 1 or step 2 treatments according to GINA report will be recruited. A total of approximately 1200 patients will be enrolled. Patients will be followed-up during a 6-month observational period according to standard practices.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adult subject (aged ≥ 18 years) up to 75 years
  • Subject with confirmed asthma diagnosis
  • Subject in treatment for mild asthma with Step 1 or Step 2 according to GINA report
  • Subject with written privacy and study informed consent

Exclusion criteria

  • Subject enrolled in experimental (interventional) clinical trials, or receiving experimental treatments in the prior 3 months
  • Known pregnant or breast-feeding subject
  • Subject unable to understand and autonomously fill in questionnaires
  • Subject unable to use electronic devices to fill in e-diary, or without compatible electronic devices with access to the Internet
  • Subject who had asthma exacerbation(s) in the past 4 weeks prior to study entry
  • Subject with confirmed Chronic Obstructive Pulmonary Disease

Treatment and study plan

Primary outcomes

  1. To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.

    Time frame: 6-months period

    Frequency of asthma treatments for asthma management, regardless the duration:

    • by active substance
    • by drug class
    • distinguishing between "controller" and "reliever" treatments

  2. To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.

    Time frame: 6-months period

    Frequency of subjects experiencing asthma treatment switches, step-ups and step-downs during the observation period, along with the description of pattern of switch (in terms of sequence of treatments over time)

  3. To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.

    Time frame: 6-months period

    Frequency of treatment posology, stratified by type of asthma treatment

  4. To describe the real-world patterns of treatment of subjects with mild asthma during a 6-month observational period.

    Time frame: 6-months period

    Duration of asthma treatments (in months):

    • overall
    • by drug class (i.e., any switch to drugs within the same class will be considered as a continuation of the treatment) and by active substance (i.e., any dose adaptation will be considered as a continuation of the same drug). This will be adapted according to data availability.

Secondary outcomes

  1. To describe the Socio-demographics data of subjects with mild asthma at enrolment visit

    Time frame: At enrolment

    BMI in kg/m^2

  2. To describe the clinical characteristics of subjects with mild asthma at enrolment visit

    Time frame: At enrolment

    Lifestyle and smoking habits data description

  3. To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit

    Time frame: At enrolment

    Frequency of daytime and night-time symptoms

  4. To describe the Daytime and night-time symptoms of subjects with mild asthma at enrolment visit

    Time frame: At enrolment

    Type of daytime and night-time symptoms

  5. To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit

    Time frame: At enrolment

    Time from first Asthma Diagnosis

  6. To describe the Asthma Diagnosis of subjects with mild asthma at enrolment visit

    Time frame: At enrolment

    Type of diagnosis strategy

  7. To describe the asthma exacerbations of subjects with mild asthma at enrolment visit

    Time frame: At enrolment

    Asthma exacerbations history data description

  8. To describe the prior asthma treatment of subjects with mild asthma at enrolment visit

    Time frame: At enrolment

    Type of prior Asthma treatments description

  9. To describe the clinical characteristics of subjects with mild asthma at enrolment visit

    Time frame: At enrolment

    Skin Prick test data description

  10. To describe the evolution of lung function parameters (FEV1 (L)) during the 6-month observational period

    Time frame: At enrolment and at 6-month

    Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of Forced Expiratory Volume in 1 second (FEV1) in L

  11. To describe the evolution of lung function parameters (FEV1 (%)) during the 6-month observational period

    Time frame: At enrolment and at 6-month

    Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of FEV1 predicted value in %,

  12. To describe the evolution of lung function parameters (FVC (L)) during the 6-month observational period

    Time frame: At enrolment and at 6-month

    Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): Forced Vital Capacity (FVC) in L

  13. To describe the evolution of lung function parameters (FVC (%))during the 6-month observational period

    Time frame: At enrolment and at 6-month

    Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of FVC % predicted

  14. To describe the evolution of lung function parameters (FEV1/FVC ratio) during the 6-month observational period

    Time frame: At enrolment and at 6-month

    Spirometry results at enrolment and at 6-month follow-up visit (according to sites' standard practice): measurement of FEV1/FVC ratio in %

  15. To describe subjects' level of asthma symptoms control by means of the Asthma Control Test (ACT) during the 6-month observational period

    Time frame: At enrolment and at 6-month

    ACT score. ACT is a 5-point scale (for symptoms and activities: 1=all the time to 5= not at all; for asthma control rating: 1=not controlled at all to 5=completely controlled). ACT scores range from 5 (poor control of asthma) to 25 (complete control of asthma), with higher scores reflecting greater asthma control. An ACT score >19 indicates well-controlled asthma.

  16. To describe subjects' level of asthma symptoms control by means of the Asthma Control Questionnaire (ACQ-5) during the 6-month observational period

    Time frame: At enrolment and at 6-month

    ACQ-5 score. ACQ-5 is a 7-point scale (0=no impairment, 6= maximum impairment) and scores range between 0 (totally controlled) and 6 (severely uncontrolled).

  17. To describe the occurrence of asthma exacerbations during the 6-month observational period

    Time frame: 6-months period

    Number of Asthma exacerbations during the 6-month observational period (seriousness, severity, relatedness to the treatment product, start date and end date (duration will be calculated during data analysis), outcome, action taken with respect to drug and other treatments used to treat exacerbations)

  18. To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period

    Time frame: 6-months period

    Number of Inward/Day-hospital hospitalizations, emergency room accesses and GP/outpatient specialist visits

  19. To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period

    Time frame: 6-months period

    Number and type of tests and exams per subject

  20. To describe the utilization of healthcare resources in subjects with mild asthma during the 6- month observational period

    Time frame: 6-months period

    Duration of Inward/Day-hospital hospitalizations

  21. To describe the subjects' quality of life by means of the Mini Asthma Quality of Life Questionnaire (MiniAQLQ) during the 6-month observational period

    Time frame: At enrolment and at 6-month

    MiniAQLQ scores. The MiniAQLQ is a 7-point Likert scale (7 = not impaired at all - 1 = severely impaired) and scores range 1-7, with higher scores indicating better quality of life.

  22. To describe the occurrence of adverse drug reactions (ADRs) in subjects with mild asthma during the 6-month observational period.

    Time frame: 6-month

    Only Adverse Drug Reactions (ADRs) to any asthma medication occurred during the 6-month observational period will be collected

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

A Multi-centre Multi-country Prospective obseRvatIonal Study on Patterns of Care of Mild Asthmatic patiEnts

Acronym: PRIME

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Oct 22, 2020
Registry last updated
Sep 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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