Brief advice for Chronic Obstructive Pulmonary Disease (COPD)

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Chronic Obstructive Pulmonary Disease (COPD)+1 MoreBrief advice - Behavioral
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is for smokers with COPD who want to switch to e-cigarettes. Training will be given on how to use them. It is not known if this will help people fully switch.

Eligible Conditions
  • Chronic Obstructive Pulmonary Disease (COPD)
  • Tobacco Smoking

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 9 Secondary · Reporting Duration: 12 weeks

12 weeks
Change in 6-minute walk test, meters
Change in COPD Assessment Test (CAT) score, scale of 0-40
Change in Diastolic blood pressure
Change in Respiratory Symptoms score, scale of 0-32
Change in Systolic blood pressure
Change in spirometry FEV1
Change in spirometry FEV1/FVC ratio
Change in spirometry FVC
Changes in puff duration in seconds from pre- to post-e-cigarette training
Complete switch to e-cigarette

Trial Safety

Trial Design

3 Treatment Groups

Single Training
1 of 3
Training to Competency
1 of 3
Brief Advice
1 of 3

Experimental Treatment

45 Total Participants · 3 Treatment Groups

Primary Treatment: Brief advice · No Placebo Group · N/A

Single Training
Behavioral
Experimental Group · 1 Intervention: Single Training · Intervention Types: Behavioral
Training to Competency
Behavioral
Experimental Group · 1 Intervention: Training to Competency · Intervention Types: Behavioral
Brief Advice
Behavioral
Experimental Group · 1 Intervention: Brief advice · Intervention Types: Behavioral
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Brief advice
2010
Completed Phase 4
~3440

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 12 weeks

Who is running the clinical trial?

University of Kansas Medical CenterLead Sponsor
401 Previous Clinical Trials
158,324 Total Patients Enrolled
1 Trials studying Chronic Obstructive Pulmonary Disease (COPD)
12 Patients Enrolled for Chronic Obstructive Pulmonary Disease (COPD)
Eleanor LeavensPrincipal InvestigatorUniversity of Kansas Medical Center

Eligibility Criteria

Age 18+ · All Participants · 10 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have been diagnosed with COPD.
You are able to speak and understand English.
You smoke on more than 25 days of the last 30 days.
You are willing to switch from cigarettes to the study e-cigarette for the duration of the study.
You are 21 years old or older.
You are willing to complete six study visits.
You are unwilling to make a quit attempt in the next 30 days.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
University of Kansas Medical Center100.0%
What portion of applicants met pre-screening criteria?
Met criteria100.0%