Trial Outcomes & Findings for Ventilator Adapters for Combivent Respimat (NCT NCT01969539)

Results Overview

Pre-dose subtracted maximum measured concentration (Cmax) of ipratropium. Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint.

Recruitment status

TERMINATED

Study phase

PHASE4

Target enrollment

11 participants

Primary outcome timeframe

Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication

Results posted on

2025-02-10

Participant Flow

The study was closed early based on the results of an interim pharmacokinetic analysis, prior to enrollment of any patient in cohort 2, therefore only the Trudell adapter was assessed (in cohort 1)

Participant milestones

Participant milestones
Measure	Combivent Respimat Via Trudell Adapter Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
Overall Study STARTED	11
Overall Study COMPLETED	11
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Ventilator Adapters for Combivent Respimat

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Combivent Respimat Via Trudell Adapter n=11 Participants Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
Age, Continuous	70.4 Years STANDARD_DEVIATION 10.45 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants
Sex: Female, Male Male	6 Participants n=5 Participants

PRIMARY outcome

Timeframe: Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication

Population: Treated set

Pre-dose subtracted maximum measured concentration (Cmax) of ipratropium. Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint.

Outcome measures

Outcome measures
Measure	Combivent Respimat Via Trudell Adapter n=11 Participants Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
Pre-dose Subtracted Maximum Measured Concentration of Ipratropium 1 puff (20/100 μg Ipr/Alb) (N=5)	6.12 pg/ml Standard Deviation 4.1
Pre-dose Subtracted Maximum Measured Concentration of Ipratropium 2 puffs (40/200 μg Ipr/Alb) (N=9)	12.0 pg/ml Standard Deviation 5.5
Pre-dose Subtracted Maximum Measured Concentration of Ipratropium 4 puffs (80/400 μg Ipr/Alb) (N=6)	26.4 pg/ml Standard Deviation 11.6

PRIMARY outcome

Timeframe: Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication

Population: Treated set

Pre-dose subtracted maximum measured concentration (Cmax) of albuterol. Standard pharmacokinetic (PK) analyses were not conducted due to a carry-over effect. As a consequence, the pre-specified primary endpoint (maximum measured concentration of ipratropium and albuterol) was not reported. The predose subtracted Cmax was calculated instead of the primary endpoint.

Outcome measures

Outcome measures
Measure	Combivent Respimat Via Trudell Adapter n=11 Participants Participants received 20 μg ipratropium bromide and 100 μg of albuterol, administered by oral inhalation via the Trudell adapter. Patients received one, two, and four puffs in a sequential order, each dose was administered 6 hours apart.
Pre-dose Subtracted Maximum Measured Concentration of Albuterol 1 puff (20/100 μg Ipr/Alb) (N=7)	0.192 ng/ml Standard Deviation 0.352
Pre-dose Subtracted Maximum Measured Concentration of Albuterol 2 puffs (40/200 μg Ipr/Alb) (N=10)	0.252 ng/ml Standard Deviation 0.435
Pre-dose Subtracted Maximum Measured Concentration of Albuterol 4 puffs (80/400 μg Ipr/Alb) (N=10)	0.132 ng/ml Standard Deviation 0.083

SECONDARY outcome

Timeframe: Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication

Population: Treated set

Area under the concentration-time curve over the time interval from 0 to 6 hour (AUC 0-6) of ipratropium and albuterol. This secondary endpoint was not calculated due to a carry-over effect.

Outcome measures

Outcome data not reported

Adverse Events

Combivent Respimat Via Trudell Adapter

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Boehringer Ingelheim Call Center

Boehringer Ingelheim

Phone: 1-800-243-0127

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee Boehringer Ingelheim (BI) acknowledges that investigators have the right to publish the study results. Investigators shall provide BI with a copy of any publication or presentation for review prior to any submission. Such review will be done with regard to proprietary information, information related to patentable inventions, medical, scientific, and statistical accuracy within 60 days. BI may request a delay of the publication in order to protect BI's intellectual property rights.
Publication restrictions are in place

Restriction type: OTHER