An Observational Prospective Study to Characterize Patients Initiating Enerzair® Breezhaler®, With or Without Sensor, as a Maintenance Treatment for Asthma

NCT05120986 | Withdrawn

• 1 other identifier: CQVM149BPT01
• Study Type: observational
• Target: N/A
• Locations: 0 countries
• Sites: N/A

Brief Summary

This is an observational, descriptive, open-label, prospective, 6-month study including a group of patients with a first prescription of IND/GLY/MF with sensor and a group with a first prescription of IND/GLY/MF without sensor.

Conditions

Asthma

Keywords

Asthma; SENSE study; Enerzair; Breezhaler; maintenance treatment

Outcome Measures

Primary Outcomes (14)

• Baseline sociodemographic - living status

  Assess if the patient lives alone: * Yes * No * Don't know/ Don't answer

  Baseline

• Baseline sociodemographic - household income

  Patient's household net income level: * \<665 € * \[665€ to 1000€\[ * \[1000€ to 1200€\[ * \[1400€ to 1700€\[ * \[1700€ to 2000€\[ * \[2000€ to 2700€\[ * ≥2700€ * Don't know/Don't answer

  Baseline

• Baseline sociodemographic - educational level

  Patient's highest completed educational level: * None * I - Basic education (4 years) * II - Basic education (6 years) * III - Basic education (9 years) * Upper secondary education or equivalent (12 years) * Bachelor/ University Degree * Don't know/Don't answer

  Baseline

• Baseline sociodemographic - employment status

  Patient Employment status: * Employed. Number of hours per week. * Unemployed * Student * Retired * Other. Specify. * Don't know/Don't answer

  Baseline

• clinical characteristics - body mass index

  body mass index will be provided

  Baseline

• clinical characteristics - smoking status

  Patient smoking status: * Never smoked * Ex-smoker * Smoker * Don't know/Don't answer

  Baseline

• clinical characteristics - comorbidities

  Patient comorbidities: * Allergic rhinitis * Rhinosinusitis * Allergic conjunctivitis * Sleep disorders * Anxiety * Depression * Other. Specify

  Baseline

• clinical characteristics - duration of disease

  duration of disease will be provided

  Baseline

• clinical characteristics - age at asthma diagnosis

  Age when asthma was diagnosed: * Years * Unknown/cannot remember

  Baseline

• clinical characteristics - asthma-related hospitalizations

  Number of hospitalizations: * n of hospitalizations * Don't know/Don't answer

  Baseline

• clinical characteristics - emergency admissions and non-scheduled visits in the previous 12 months

  Number of appointments: * number of scheduled asthma physician's appointments * number of unscheduled asthma physician's appointments * Don't know/Don't answer

  Baseline

• clinical characteristics - ACT score

  The Asthma Control Test (ACT) contains 5 questions that are related to the frequency of both asthma symptoms and required rescue medication use during the previous 4 weeks. The scores in the ACT range from 5 (worse control) to 25 (total control)

  Baseline

• clinical characteristics - TAI score

  The TAI questionnaire was developed to measure self-reported adherence to inhaler devices and help clinicians to evaluate non-adherence barriers related to inhaled therapy in adult patients with asthma or chronic obstructive pulmonary disease. The interpretation of adherence based on the 10-item TAI, scoring is that an overall score of 50 points highlights good adherence, while a score of between 46 to 49 points denotes intermediate adherence. A total score ≤ 45 points indicates poor adherence

  Baseline

• clinical characteristics - last asthma treatment

  International Nonproprietary Name (INN) of Last asthma medication

  Baseline

Secondary Outcomes (18)

• Changes from baseline in self-reported adherence - TAI questionnaire score

  Baseline, month 3, month 6

• Changes from baseline in self-reported adherence - asthma control test (ACT) score

  Baseline, month 3, month 6

• Adherence from the app (percentage)

  Month 3, month 6

• Asthma control from the app (category)

  Month 3, month 6

• Rescue medication from the app

  Month 3, Month 6

Study Arms (2)

IND/GLY/MF with sensor

Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate with sensor

Other: IND/GLY/MF

IND/GLY/MF without sensor

Patients prescribed with indacaterol acetate, glycopyrronium bromide and mometasone furoate without sensor

Other: IND/GLY/MF

Interventions

IND/GLY/MF OTHER

Prospective observational cohort study. There is no treatment allocation. Patients will be invited to participate in the study when attending participating community pharmacies with a first prescription of IND/GLY/MF with sensor or IND/GLY/MF without sensor

Also known as: Enerzair® Breezhaler®

IND/GLY/MF with sensor; IND/GLY/MF without sensor

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with a first prescription of IND/GLY/MF with sensor and a group of patients with a first prescription of IND/GLY/MF without sensor at a community pharmacy setting.

You may qualify if:

• Male and female patients aged ≥18 years
• Self-reported diagnosis of asthma
• Individual filling a first prescription of IND/GLY/MF with or without sensor in a participating community pharmacy for himself/herself (excluding caregivers).
• Individual capable and willing to perform the study assessments.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

MeSH Terms

Conditions

Asthma

Condition Hierarchy (Ancestors)

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

Study Officials

• Novartis Pharmceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 3, 2021
• First Posted: November 16, 2021
• Study Start: February 15, 2022
• Primary Completion: May 15, 2023
• Study Completion: May 15, 2023
• Last Updated: April 4, 2022

Record last verified: 2022-03

Data Sharing

• IPD Sharing: Will not share