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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT01969539
Other study ID # 1012.65
Secondary ID
Status Terminated
Phase Phase 4
First received October 14, 2013
Last updated January 19, 2016
Start date October 2013
Est. completion date November 2014

Study information

Verified date January 2016
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Terminated
Enrollment 11
Est. completion date November 2014
Est. primary completion date November 2014
Accepts healthy volunteers No
Gender Both
Age group 40 Years and older
Eligibility Inclusion criteria:

- 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.

Exclusion criteria:

- 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.

- Patients who are currently participating in another study. Note that patients who have previously been entered into this study and have been tested with one of the two adapters are eligible for re-entry into the trial to be studied with the alternate adapter (after a minimum of 48 hours post completion of the "active" portion of the trial with the first adapter), and if all inclusion and no exclusion criteria are met.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

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

Locations

Country Name City State
United States 1012.65.00001 Boehringer Ingelheim Investigational Site Danbury Connecticut
United States 1012.65.00002 Boehringer Ingelheim Investigational Site Fort Worth Texas

Sponsors (1)

Lead Sponsor Collaborator
Boehringer Ingelheim

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Primary 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 No
Secondary Area Under the Concentration-time Curve Over the Time Interval From 0 to 6 Hour (AUC 0-6) of Ipratropium and Albuterol 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.
Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication No
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