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

NCT ID: NCT05120986

Last Updated: 2022-04-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-15

Study Completion Date

2023-05-15

Brief Summary

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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.

Detailed Description

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Patients will be invited prospectively and sequentially to participate in the study when attending a participating community pharmacy with a first prescription of IND/GLY/MF with sensor or IND/GLY/MF without sensor. Therefore, the invitation for the patient to participate in the study will occur only after the therapeutic decision has taken place

Conditions

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Asthma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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IND/GLY/MF with sensor

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

IND/GLY/MF

Intervention Type 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

IND/GLY/MF without sensor

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

IND/GLY/MF

Intervention Type 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

Interventions

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IND/GLY/MF

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

Intervention Type OTHER

Other Intervention Names

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Enerzair® Breezhaler®

Eligibility Criteria

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Inclusion Criteria

* 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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Other Identifiers

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CQVM149BPT01

Identifier Type: -

Identifier Source: org_study_id

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