Actuation Indicator Trial in Patients With COPD

ATROVENT HFA Actuation Indicator Open-Label Study in Adults With Chronic Obstructive Pulmonary Disease (COPD)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00928746

Enrollment

142

Registered

2009-06-26

Start date

2009-06-30

Completion date

Unknown

Last updated

2014-07-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Brief summary

The primary objective of this study is to evaluate the performance, accuracy, and handling of the actuation indicator in patients with COPD. The actuation indicator is integrated into mouthpiece of the ipratropium bromide HFA inhalation aerosol device. As part of Boehringer Ingelheim's program to qualify an actuation indicator for use with the ipratropium bromide HFA inhalation aerosol device, this study is intended to complement the results from the ongoing in-vitro studies.

Interventions

DEVICEIpratropium bromide

Study design

Primary purpose

TREATMENT

Eligibility

Sex/Gender

ALL

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

1. A diagnosis of COPD based on medical history at a severity to require maintenance treatment with a bronchodilator 2. Male or female patients 40 years of age or older 3. A smoking history of more than ten pack-years. A pack-year is defined as the equivalent of smoking one pack of 20 cigarettes per day for a year 4. Must be able to use the study MDI with the mouthpiece containing actuation indicator

Exclusion criteria

1. Significant diseases other than COPD are excluded. A significant disease is defined as a disease which in the opinion of the investigator may either put the patient at risk because of participation in the study or a disease which may influence the results of the study or the patient's ability to participate in the study 2. Malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last three months. Patients with treated basal cell carcinoma are allowed 3. History of asthma 4. Significant history active alcohol or drug abuse 5. Known active tuberculosis 6. Known narrow-angle glaucoma 7. Current significant psychiatric disorders 8. Pregnant or nursing women or women of childbearing potential not using a medically approved means of contraception (i.e., oral contraceptives, intrauterine devices or diaphragm with spermicide, or Norplant®) 9. Known hypersensitivity to anticholinergic drugs, any other component of the ipratropium bromide, HFA-134a or MDI components 10. Previous participation in this trial 11. Patients who are currently participating in another trial and/or who have received investigational drug within the past 30 days

Design outcomes

Primary

Measure	Time frame	Description
Actuations Registered by the Actuation Indicator	21 Days	This outcome measure presents the number of actuations (doses) of medication used in the specific time frame as measured by the actuation indicator
Actuations Dispensed	21 Days	Actuations dispensed is determined by the weight differential of the canister over the course of the study divided by the shot weight
Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed	21 Days	Difference between the number of actuations registered by the actuation indicator and the number of actuations dispensed (calculated using weight differential and shot weight)

Secondary

Measure	Time frame	Description
Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed	21 Days	Difference between the number of actuations recorded on patient diary and the number of actuations dispensed (calculated using weight differential and shot weight)
Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed	21 Days	Difference between the number of actuations based on advancing the actuation indicator to a zero reading or to the next increment and the number of actuations dispensed (calculated using weight differential and shot weight)
Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed	21 Days	—
Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire	21 Days	—
Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire	21 Days	—
Actuations Recorded on Patient Diary	21 Days	—
Number of Participants Who Reported Satisfaction With Performance of the Dose Counter for Indicating Approximately How Many Doses Remain in Inhaler According to Patient Handling Questionnaire	21 Days	—
Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire	21 Days	—
Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire	21 Days	—
Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire	21 Days	—
Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire	21 Days	—
Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire	21 Days	—
Actuations Based on Advancing the Actuation Indicator	21 Days	Actuations based on advancing the actuation indicator to a zero reading or to the next increment
Actuations Registered by the Actuation Indicator and Read by Site Coordinator	21 Days	—

Countries

United States

Participant flow

Participants by arm

Arm	Count
ATROVENT 42mcg ATROVENT HFA (42 mcg)- Oral inhalation	142
Total	142

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Adverse Event	2
Overall Study	Other	2
Overall Study	Protocol Violation	1
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	ATROVENT 42mcg
Age, Continuous	58.7 years STANDARD_DEVIATION 9.2
Alcohol status Does not drink alcohol	94 participants
Alcohol status Drinks alcohol - should not interfere with trial	48 participants
Height	167.2 centimeters STANDARD_DEVIATION 15.7
Race/Ethnicity, Customized Black or African American	20 participants
Race/Ethnicity, Customized White	122 participants
Sex: Female, Male Female	65 Participants
Sex: Female, Male Male	77 Participants
Smoking history Currently smoke	80 participants
Smoking history Ex-smoker	62 participants
Weight	88.8 kilograms STANDARD_DEVIATION 27.7

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	— / —
other Total, other adverse events	0 / 142
serious Total, serious adverse events	2 / 142

Outcome results

Primary

Actuations Dispensed

Actuations dispensed is determined by the weight differential of the canister over the course of the study divided by the shot weight

Time frame: 21 Days

Population: The primary analysis was performed using the Full Analysis Set (FAS)

Arm	Measure	Value (MEDIAN)	Dispersion
ATROVENT 42mcg	Actuations Dispensed	159.77 Count	Standard Deviation 20.78

Primary

Actuations Registered by the Actuation Indicator

This outcome measure presents the number of actuations (doses) of medication used in the specific time frame as measured by the actuation indicator

Time frame: 21 Days

Population: The primary analysis was performed using the Full Analysis Set (FAS).

Arm	Measure	Value (MEDIAN)	Dispersion
ATROVENT 42mcg	Actuations Registered by the Actuation Indicator	167 Count	Standard Deviation 19.44

Primary

Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed

Difference between the number of actuations registered by the actuation indicator and the number of actuations dispensed (calculated using weight differential and shot weight)

Time frame: 21 Days

Population: The primary analysis was performed using the Full Analysis Set (FAS)

Arm	Measure	Value (MEDIAN)	Dispersion
ATROVENT 42mcg	Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed	1.85 Count	95% Confidence Interval 9.8

Secondary