Clinical Trial Details
— Status: Withdrawn
Administrative data
| NCT number |
NCT04042168 |
| Other study ID # |
IRB-300003947 |
| Secondary ID |
|
| Status |
Withdrawn |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
September 25, 2019 |
| Est. completion date |
August 9, 2022 |
Study information
| Verified date |
August 2022 |
| Source |
University of Alabama at Birmingham |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial 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. the frequency of COPD patients demonstrating an appropriate use of inhalers that have
flow-triggered systems,
2. whether the appropriate use of inhalers impacts the Quality of Life and Shortness of
Breath of COPD patients, and
3. the impact of appropriate use of inhalers on FEV1 in COPD patients.
Description:
Chronic obstructive pulmonary disease (COPD) is a chronic systemic inflammatory disease
associated with substantial morbidity and mortality and is now the 3rd leading cause of death
in the United States. The majority of COPD-related symptoms are managed using inhaled
therapy. Inhalation is a safe, efficacious and quick way for drug delivery. Inhaled therapy
permits direct availability of the active drug to the lungs, requiring lower doses of the
drug and causing lower systemic side effects as compared to oral therapy. There are four
major types of inhalation devices: pressurized metered-dose inhalers (MDI), dry powder
inhalers (DPI), soft mist inhalers (SMI), and nebulizers. Every type has its advantages and
disadvantages that are important to understand to determine their suitability for COPD
patients. Despite that, choosing the appropriate device for patients remains a challenge for
the prescribing physician.
For all inhaler devices, training patients on how to use them appropriately is required to
attain ideal therapeutic benefits. Multiple studies have estimated that about 28-68% of
patients were inappropriately using their inhalation devices to benefit from the prescribed
drug. Brocklebank et al. performed a systematic review looking at the effectiveness of
inhaler device use in COPD and asthma patients. They found that ideal inhaler scores were
reached by 59% of subjects with DPIs and 43% with MDIs. 5 on the other hand, the aggregate
data from this systematic review showed that after teaching the correct technique there was
no difference in patients' ability to use DPI or MDIs. One of the common problems leading to
inappropriate use of the inhalation devices is breath asynchrony. An in-vitro study done by
Wilkes et al. showed that breath asynchrony significantly decreases the mass of medication
inhaled from an MDI. It showed that actuation of only one second earlier to inhalation
decreases the inhaled mass of medication by about 90%. Likewise, actuation later on in the
inspiratory cycle could lead to filling the anatomic dead space with the aerosolized
medication. This issue seems to be less pronounced in DPI devices, as those systems are
mainly passive in their function depending on the mechanical effort of the patient to release
the medication and supply it to the effective areas inside the lungs through inspiration. On
the other hand, there seem to be multiple factors leading to suboptimal use of DPIs such as
the inability to activate the device with enough inspiratory effort.
Very limited studies looked at the inspiratory effort for COPD patients and the efficacy of
inhaler use. Burnell et al. looked at the performance of 17 COPD patients with severe
obstruction using an inhalation simulator to establish dosing performance of the Diskus
inhaler with fluticasone and Turbuhaler inhaler with budesonide. Peak inspiratory flow was
significantly higher through the Diskus as compared with Turbuhaler (mean 82.3 l/min vs 53.5
l/min, P < 0.001). Also, the Diskus inhaler was shown that drug delivery was more dependent
on peak inspiratory flow with the Turbuhaler than with the Diskus. On the other hand, a study
looked at the performance of a high resistance inhaler (HandiHaler) in 26 men with stable
COPD. Patients were categorized into 3 groups of severity, based on their predicted
FEV-1(less than 27%, 28 - 45%, and more than 46%) and then measured the inspiratory flow
through the HandiHaler. The median peak inspiratory flow rates for each group were 45, 45.6,
and 35.4 L/min respectively. The minimum peak inspiratory flow rates were 28.2, 21.6 and 20.4
L/min. The authors then conducted an in-vitro analysis to assess the minimum inspiratory flow
rate indicated for the delivery of the medication and found to be at flow rates as low as 20
l/min. They concluded that drug delivery was adequate despite the severity of COPD. Up to our
knowledge, no previous studies looked at the change of symptoms control in-vivo in relation
to the inhalation effort of COPD patients and the appropriate use of their inhalers.
The investigators hypothesize that COPD patients with high peak inspiratory flow rates and
appropriate use of inhalers device have better symptoms control with using breath-actuated
inhalers as compared to patients who fail to actuate inhalers devices (inappropriate use of
inhalers) and have low peak inspiratory flow.
The investigators have designed a prospective study to determine the inspiratory effort
status and the change of symptoms in stable COPD patients seen as outpatient. Pulmonary
function testing, COPD related quality of life and shortness of breath will be assessed at
baseline and 3 months after obtaining the status of inhalers use at baseline.
