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

Study Overview
=================
Brief Summary
-----------------
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.

Detailed Description
-----------------
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.

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

Conditions
-----------------
Asthma, Copd

Intervention / Treatment
-----------------
* Device: Respimetrix


Participation Criteria
=================
Eligibility Criteria
-----------------
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)

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Interventional Model Description: patients are screened, consented, and all go through the inhaler training.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: MDI Training<br>All participants are led through the MDI training with the Respimetrix Device. Protocol is within groups design. | Device: Respimetrix<br>* 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.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in pressurized metered-dose inhaler (pMDI) performed after training using Respimetrix device | Measure actuation timing, flow rate and volume after intervention | 2 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describing baseline pressurized metered-dose inhaler (pMDI) technique | Measure actuation timing, flow rate and volume before intervention. | 2 weeks |