Ventilator Adapters for Combivent Respimat

NCT01969539 | Terminated Phase 4 Results

• 1 other identifier: 1012.65
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 2

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Pre-dose Subtracted Maximum Measured Concentration of Ipratropium

  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-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 of Albuterol

  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.

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

Secondary Outcomes (1)

• 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

Study Arms (2)

Combivent Respimat via tee adapter

EXPERIMENTAL

Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter

Drug: Combivent Respimat via tee adapter

Combivent Respimat - ventilator adapter

EXPERIMENTAL

Patients (all); previously intubated and ventilated; in need of bronchodilation with /CVT-R via ventilator adapter

Drug: Combivent Respimat via ventilator adapter

Interventions

Combivent Respimat via tee adapter DRUG

Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter

Combivent Respimat via tee adapter

Combivent Respimat via ventilator adapter DRUG

Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via ventilator adapter

Combivent Respimat - ventilator adapter

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients or their health care proxy must sign an informed consent consistent with International Conference on Harmonization (ICH)-Good Clinical Practice (GCP) guidelines prior to participation in the trial.
• Male or female patients, 40 years of age or older
• Patients must have a pre-admission/pre-ventilation diagnosis of obstructive lung disease (emphysema, chronic bronchitis, or asthma, or a combination thereof), and have a history of treatment with an inhaled bronchodilator. Note that the availability of prior confirmatory spirometry is desirable but not required for participation in the trial
• Patients must have a clinically relevant and acceptable elective or semi-elective indication for intubation and initiation of mechanical ventilation prior to consideration for trial enrollment.

You may not qualify if:

• Patients with disease, respiratory or non-respiratory, that is sufficiently unstable (beyond the need for intubation and routine mechanical ventilation) such that their condition will, in the opinion of the investigator (i) put them at risk because of participation in the study, (ii) influence the results of the study \[including the assessment of pharmacokinetic parameters\], or (iii) cause concern regarding their ability to participate in the study for its duration of one (nominal) day.
• Patients with any of the following specific conditions:
• Any systemic or respiratory condition or degree of instability that in the judgment of the principal investigator renders the patient unlikely to safely participate in or complete the study. Investigators are encouraged to contact the trial clinical monitor or team member medicine should there be any question about the suitability of a particular patient for this study.
• A diagnosis of thyrotoxicosis (due to the known class side effect profile of ß2-agonists)
• A diagnosis of paroxysmal tachycardia (\>100 beats per minute) (due to the known class side effect profile of ß2-agonists)
• Active/unstable cardiac ischemia
• Unstable or life-threatening cardiac arrhythmia
• Unstable heart failure (typically Class III or IV)
• Renal and/or hepatic failure to an extent likely to significantly affect drug metabolism and the consequent effect on the determination of pharmacokinetic parameters as determined by the investigator.
• Known active tuberculosis
• Currently under treatment with chemotherapy or radiation therapy for a malignancy.
• Patients who have taken an investigational drug within one month or six half lives (whichever is greater) prior to screening. (Note that for the purpose of this trial, commercially available and previously prescribed/administered Combivent Respimat® or Combivent Metered Dose Inhaler (MDI) will not be precluded as "investigational".)
• Patients with known hypersensitivity to ß-adrenergics drugs, anticholinergic drugs, Benzalkonium chloride (BAC), Ethylenediaminetetraacetic acid (EDTA), or any other component of the Respimat® inhalation solution delivery system
• Pregnant or nursing women
• Women of childbearing potential not using two effective methods of birth control (one barrier and one non-barrier). Female patients will be considered to be of childbearing potential unless surgically sterilized by hysterectomy or bilateral tubal ligation, or post-menopausal for at least two years.However, as subjects in this study will be sedated, on mechanical ventilation for life support and under 24/7 continuous observation in the critical care setting, the use of additional birth control during the study period is not applicable.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (2)

1012.65.00001 Boehringer Ingelheim Investigational Site

Danbury, Connecticut, United States

Location

1012.65.00002 Boehringer Ingelheim Investigational Site

Fort Worth, Texas, United States

Location

Related Links

• Related Info

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

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)

Results Point of Contact

• Title: Boehringer Ingelheim Call Center
• Organization: Boehringer Ingelheim

clintriage.rdg@boehringer-ingelheim.com

1-800-243-0127

Study Officials

• Boehringer Ingelheim

  Boehringer Ingelheim

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2013
• First Posted: October 25, 2013
• Study Start: October 14, 2013
• Primary Completion: November 20, 2014
• Study Completion: November 21, 2014
• Last Updated: February 10, 2025
• Results First Posted: February 15, 2016

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)