Ventilator Adapters for Combivent Respimat
Condition: Pulmonary Disease, Chronic Obstructive
MeSH terms: Pulmonary Disease, Chronic Obstructive
Intervention: Combivent Respimat via tee adapter; Combivent Respimat via ventilator adapter
Intervention description: Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter; Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via ventilator adapter
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Non-Randomized
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 11.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

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.
    

Eligibility criteria:

        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.