Implications of Appropriate Use of Inhalers in Chronic Obstructive Pulmonary Disease (COPD)

NCT04042168 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: IRB-300003947
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Using various types of inhalers is the treatment cornerstone for COPD patients to control their symptoms. Many inhaler devices require minimum inspiratory effort to activate the device, COPD patients commonly use such devices. Those devices deliver the medications only when the patient forcefully inhales so the drug can reach the lungs, thus exerting their therapeutic action. The effect of appropriate use of the inhalers in patients with COPD is not well studied, and the impact of demonstrating that a patient can inhale forcefully enough to activate a device on its' effect on symptoms is also lacking in the medical literature. The purpose of this study is to find out:

1. 1.the frequency of COPD patients demonstrating an appropriate use of inhalers that have flow-triggered systems,
2. 2.whether the appropriate use of inhalers impacts the Quality of Life and Shortness of Breath of COPD patients, and
3. 3.the impact of appropriate use of inhalers on FEV1 in COPD patients.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

COPD; Inhalers

Outcome Measures

Primary Outcomes (4)

• Proportion of subjects with COPD on inappropriate inhalers

  The frequency of COPD patients demonstrating an inappropriate use of inhalers that have flow-triggered systems

  Baseline

• Change in St George's Respiratory Questionnaire (SGRQ) Score in 3 months

  Whether the appropriate use of inhalers impacts the quality of life and symptom control of COPD patients. SGRQ score ranges from 0 to 100, higher the score worse the quality of life. A change of 4 units is considered the minimum clinically important difference.

  3 months

• Change in the forced expiratory volume in the first second (FEV1) in 3 months

  Whether the appropriate use of inhalers impacts the lung function of COPD patients.

  3 months

• Change in shortness of breath in 3 months measured using the San Diego Shortness of breath Questionnaire.

  Whether the appropriate use of inhalers impacts shortness of breath in COPD patients. The Shortness of Breath Questionnaire score ranges from 0 to 100, higher the score worse the quality of life. A change of 5 units is considered the minimum clinically important difference.

  3 months

Study Arms (1)

Intervention

EXPERIMENTAL

Inappropriate use of inhalers and medication change. Pre-post intervention data will be compared.

Diagnostic Test: In Check Dial test

Interventions

In Check Dial test DIAGNOSTIC_TEST

In Check Dial test will test the ability to actuate the inhaler.

Intervention

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• provide informed consent
• age 40 and older
• history of COPD
• screen at pulmonology clinic
• on at least one maintenance inhaler

You may not qualify if:

• Patients with a secondary diagnosis of congestive heart failure and other respiratory conditions that the investigators deem could confound the diagnosis including but not limited to pneumonia
• bronchiectasis and lung cancer will be excluded
• pregnant or breastfeeding women will be excluded
• patients with conditions that preclude an adequate peak inspiratory flowmetry including but limited to facial deformities
• neurologic disorders precluding command following
• trachestomy dependent patients

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Department of Medicine, Pulmonary Division

Birmingham, Alabama, 35294, United States

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Model Details: UAB Pulmonary Clinic Patients with history of COPD

Study Record Dates

• First Submitted: May 30, 2019
• First Posted: August 1, 2019
• Study Start: September 25, 2019
• Primary Completion: August 9, 2022
• Study Completion: August 9, 2022
• Last Updated: August 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)