Ventilator Adapters for Combivent Respimat

Phase 4

Terminated

• Conditions: Pulmonary Disease, Chronic Obstructive
• Interventions: Drug: Combivent Respimat via tee adapter; Drug: Combivent Respimat via ventilator adapter

• Registration Number: NCT01969539
• Lead Sponsor: Boehringer Ingelheim

Brief Summary

The general aim of this 1-day, open label, non-randomised, trial is to characterize the performance of two adapter devices designed to permit use of the Respimat® inhaler with patients requiring mechanical ventilation.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-10
• Study First Submitted: 2013-10-14
• Study First Submitted QC: 2013-10-18
• Study First Posted: 2013-10-25
• Primary Completion: 2014-11
• Study Completion: 2014-11
• Results First Submitted: 2015-11-19
• Status Verified: 2016-01
• Results First Submitted QC: 2016-01-19
• Last Update Submitted: 2016-01-19
• Results First Posted: 2016-02-15
• Last Update Posted: 2016-02-15

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 11

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Combivent Respimat via tee adapter	Combivent Respimat via tee adapter	Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter
Combivent Respimat - ventilator adapter	Combivent Respimat via ventilator adapter	Patients (all); previously intubated and ventilated; in need of bronchodilation with /CVT-R via ventilator adapter

Primary Outcome Measures

Name	Time	Method
Pre-dose Subtracted Maximum Measured Concentration of Ipratropium	Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication	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.
Pre-dose Subtracted Maximum Measured Concentration of Albuterol	Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication	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.

Secondary Outcome Measures

Name	Time	Method
Area Under the Concentration-time Curve Over the Time Interval From 0 to 6 Hour (AUC 0-6) of Ipratropium and Albuterol	Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication	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.

Trial Locations

Locations (2)

1012.65.00001 Boehringer Ingelheim Investigational Site; 🇺🇸 Danbury, Connecticut, United States

1012.65.00002 Boehringer Ingelheim Investigational Site; 🇺🇸 Fort Worth, Texas, United States