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OpenTrials
Completed

NCT Number: NCT05495256

Monitoring Metered Dose Inhalation (MDI) Volume and Timing With a Respimetrix Device in Obstructive Lung Disease.

To Determine whether use of the Respimetrix flow test device a) can determine "good" versus "poor" inhaler techniques, and b) the effects of the inhaler training on technique.

Completed

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Key information

Conditions

Asthma Bronchial Diseases COPD Chronic Disease Disease Attributes Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Pulmonary Disease, Chronic Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Pulmonary and Critical Care Associates Of Baltimor

Towson, Maryland, 21286, United States

About this study

Good metered dose inhaler (MDI) technique is described as sitting or standing upright with the head slightly tilted back, exhaling fully, and then inhaling slowly and deeply as you activate the MDI. Common mistakes include: not exhaling fully; not inhaling deeply enough; inhaling too quickly, and not activating the MDI at the proper time.

This study will use the Respimetrix device with placebo to assess a patient's inhaler technique, provide training to patients who demonstrate poor inhaler technique, and remotely track a subject's breathing ability over time.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients 18 years of age or older
  • Current diagnosis of asthma or Chronic obstructive pulmonary disease (COPD) patients
  • Patients must be willing and able to provide informed consent to participate in the the study.
  • Patients must be able to use a metered dose inhaler

Exclusion criteria

  • Contraindication to inhaler use
  • Tracheostomy
  • Incapacitating disability that interferes with the use of the inhaler or execution of the protocol
  • Unable to understand informed consent (e.g. non-English speakers)

Treatment and study plan

Respimetrix

Device

The Respimetrix device has a low resistance airflow sensor with an inhaler to measure patients inspiratory airflow and volume. This device will thereby provide quantifiable measures of lung function and bronchodilator delivery.

Primary outcomes

  1. Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device

    Time frame: 2 weeks

    Measure actuation timing, flow rate and volume after intervention

Secondary outcomes

  1. Describing baseline pressurized metered-dose inhaler (pMDI) technique

    Time frame: 2 weeks

    Measure actuation timing, flow rate and volume before intervention.

Sponsors and collaborators

Lead sponsor

Pulmonary Critical Care Associates of Baltimore

Other

Collaborators

  • Gerresheimer

Registry information

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Aug 10, 2022
Registry last updated
Apr 28, 2023

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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