Trial Outcomes & Findings for Actuation Indicator Trial in Patients With COPD (NCT NCT00928746)

NCT ID: NCT00928746

Last Updated: 2014-07-02

Results Overview

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

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

142 participants

Primary outcome timeframe

21 Days

Results posted on

2014-07-02

Participant Flow

Participant milestones

Participant milestones
Measure	ATROVENT 42mcg ATROVENT HFA (42 mcg)- Oral inhalation
Overall Study STARTED	142
Overall Study COMPLETED	136
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Reasons for withdrawal
Measure	ATROVENT 42mcg ATROVENT HFA (42 mcg)- Oral inhalation
Overall Study Adverse Event	2
Overall Study Protocol Violation	1
Overall Study Withdrawal by Subject	1
Overall Study Other	2

Baseline Characteristics

Actuation Indicator Trial in Patients With COPD

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	ATROVENT 42mcg n=142 Participants ATROVENT HFA (42 mcg)- Oral inhalation
Age, Continuous	58.7 years STANDARD_DEVIATION 9.2 • n=93 Participants
Sex: Female, Male Female	65 Participants n=93 Participants
Sex: Female, Male Male	77 Participants n=93 Participants
Race/Ethnicity, Customized Black or African American	20 participants n=93 Participants
Race/Ethnicity, Customized White	122 participants n=93 Participants
Alcohol status Does not drink alcohol	94 participants n=93 Participants
Alcohol status Drinks alcohol - should not interfere with trial	48 participants n=93 Participants
Smoking history Ex-smoker	62 participants n=93 Participants
Smoking history Currently smoke	80 participants n=93 Participants
Height	167.2 centimeters STANDARD_DEVIATION 15.7 • n=93 Participants
Weight	88.8 kilograms STANDARD_DEVIATION 27.7 • n=93 Participants

PRIMARY outcome

Timeframe: 21 Days

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

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

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Actuations Registered by the Actuation Indicator	167 Count Standard Deviation 19.44

PRIMARY outcome

Timeframe: 21 Days

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

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

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Actuations Dispensed	159.77 Count Standard Deviation 20.78

PRIMARY outcome

Timeframe: 21 Days

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

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

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Difference Between the Number of Actuations Registered by Actuation Indicator Versus Actuations Dispensed	1.85 Count 95% Confidence Interval 9.8 • Interval 1.29 to 2.9

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Actuations Recorded on Patient Diary	168 Count Standard Deviation 20.57

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Actuations based on advancing the actuation indicator to a zero reading or to the next increment

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=121 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Actuations Based on Advancing the Actuation Indicator	166 Count Standard Deviation 19.57

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Actuations Registered by the Actuation Indicator and Read by Site Coordinator	164 Count Standard Deviation 19.66

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Difference between the number of actuations recorded on patient diary and the number of actuations dispensed (calculated using weight differential and shot weight)

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Difference Between the Number of Actuations Recorded on Patient Diary Versus Actuations Dispensed	5.07 Count 95% Confidence Interval 18.85 • Interval 3.11 to 8.54

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

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)

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=121 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Difference Between the Number of Actuations Based on Advancing Actuation Indicator Versus Actuations Dispensed	1.71 Count 95% Confidence Interval 9.3 • Interval 0.18 to 3.84

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Difference Between the Number of Actuations Registered by the Actuation Indicator and Read by Site Coordinator Versus Actuations Dispensed	3.33 Count 95% Confidence Interval 9.8 • Interval 2.06 to 4.35

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire No	113 participants
Number of Participants Who Reported Problems With Use of Inhaler With Integrated Dose Counter According to Patient Handling Questionnaire Yes	11 participants

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire no	15 participants
Number of Participants Who Reported Problems With Seeing Red Warning Indicating Inhaler Near End of Recommended Doses According to Patient Handling Questionnaire yes	109 participants

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire No	5 participants
Number of Participants Who Reported Problems With Inhaler and Dose Counter Performing as Expected Based on Instructions According to Patient Handling Questionnaire Yes	119 participants

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
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 No	6 participants
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 Yes	118 participants

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire No	6 participants
Number of Participants Who Reported Satisfaction That the Dose Counter Worked Reliably According to Patient Handling Questionnaire Yes	118 participants

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire No	3 participants
Number of Participants Who Reported Satisfaction With Ease of Use of the Dose Counter According to Patient Handling Questionnaire Yes	121 participants

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire No	4 participants
Number of Participants Who Reported Satisfaction With Dose Counter in the Mouthpiece of the Inhaler According to Patient Handling Questionnaire Yes	120 participants

SECONDARY outcome

Timeframe: 21 Days

Population: This secondary analysis was performed using the Full Analysis Set (FAS).

Outcome measures

Outcome measures
Measure	ATROVENT 42mcg n=124 Participants ATROVENT HFA (42 mcg- Oral inhalation) - 180 Actuations group
Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire No	103 participants
Number of Participants Having Any Additional Comments According to Patient Handling Questionnaire Yes	21 participants

Adverse Events

ATROVENT 42mcg

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	ATROVENT 42mcg n=142 participants at risk ATROVENT HFA (42 mcg)- Oral inhalation
Nervous system disorders Loss of consciousness	0.70% 1/142 • Up to 21 days
Respiratory, thoracic and mediastinal disorders Respiratory failure	0.70% 1/142 • Up to 21 days

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim Pharmaceuticals

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Any publication of the result of this trial must be consistent with the Boehringer Ingelheim publication policy. The rights of the investigator and of the sponsor with regard to publication of the results of this trial are described in the investigator contract.
Publication restrictions are in place

Restriction type: OTHER