Evaluation of the Right Use of Inhaled Therapeutics

COPD Asthma Clinical Trial

— ARGOS  

Official title:

Evaluation of the Right Use of Inhaled Therapeutics Prescribed in Asthma and COPD in Adults

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03395418
• Other study ID #: 2017-A02599-44
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: November 1, 2019

Study information

• Verified date: March 2023
• Source: Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Asthma and COPD have a significant impact on public health, affecting about 8 million people in France and generating health care costs of 5.5 billion euros, almost 50% of which are dedicated to long-term treatments are essentially inhaled therapies. The good control of the disease depends on the patient's compliance, but also on the proper use of the devices used for the administration of inhaled drugs under penalty of the degradation of the control of the disease with major medical and medico-economic consequences. Thus, education of these patients in the use of devices must be an integral part of medical care. It comes up against the complexity of the therapeutic arsenal on the one hand and on the other hand with its time-consuming nature: this makes it incompatible with a realization in consultation. The "ARGOS" process is a telemonitoring project for the support of therapeutic education, consisting in setting up a concrete and real-time relay between prescribers and patients for the education of inhaled therapeutics. Its objective is to provide the answer to what is currently an "unmet need" in the management of asthma and COPD, with the prospect of a positive impact on the observance of these treatments and by consequently their clinical and economic efficiency.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: November 1, 2019
• Est. primary completion date: September 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient followed in Pneumology for asthma or COPD with a prescription for long-term inhaled therapies AND a home health provider (who monitors either home oxygen and / or respiratory equipment)
• The patient must have a means of telephone communication in order to be able to be contacted by a provider, an H2AD permanence or a doctor
• Patient having given his agreement after having been informed in writing of the purpose and the data collected during this study
• Age = 18 years
• Beneficiary of a social security scheme

Exclusion Criteria:

• Refusal of the patient
• Patient not understanding French
• Absence of home health provider
• Absence of means of telephone communication

Related Conditions & MeSH terms

• Asthma
• COPD Asthma

Locations

Country	Name	City	State
France	ANTADIR	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Association Nationale pour les Traitements A Domicile, les Innovations et la Recherche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of exploitable films	Ratio between the number of exploitable films and the number of films arriving at the telemedicine platform.	Day 1 to day 7