Pulmonary Disease, Chronic ObstructivePhase 4NCT01969539
Ventilator Adapters for Combivent Respimat
A Phase 4 study testing Combivent Respimat via tee adapter and Combivent Respimat via ventilator adapter in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Combivent Respimat via tee adapter and Combivent Respimat via ventilator adapter
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 2 sitesUnited States
- Study dates
- 14 Oct 2013to 21 Nov 2014
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 16Show fewer
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
1012.65.00001 Boehringer Ingelheim Investigational Site
Danbury, Connecticut
1012.65.00002 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
About this study
Official title: Open Label, Non-randomised, 1-day Trial to Characterize the Performance of Two Adapter Devices Designed to Permit Use of the Respimat® Inhaler Device With Patients Requiring Mechanical Ventilation.
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
- Being tested
- Combivent Respimat via tee adapter, Combivent Respimat via ventilator adapter
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Combivent Respimat via tee adapterDrug
Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter
Combivent Respimat via ventilator adapterDrug
Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via ventilator adapter
| Study group | Role | What they receive |
|---|---|---|
| Combivent Respimat via tee adapter | Experimental | Patients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter Receives: 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 Receives: Drug: Combivent Respimat via ventilator adapter |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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
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.
Measured: Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Oct 2013 (estimated)
- Study start14 Oct 2013
- Primary completion20 Nov 2014
- Study completion21 Nov 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01969539
- Sponsor's protocol ID
- 1012.65
- Status last verified
- Jan 2025
- First submitted
- 14 Oct 2013
- Last updated
- 10 Feb 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Individual data sharing
- No: Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open Label, Non-randomised, 1-day Trial to Characterize the Performance of Two Adapter Devices Designed to Permit Use of the Respimat® Inhaler Device With Patients Requiring Mechanical Ventilation.
- ClinicalTrials.gov ID
- NCT01969539
- Acronym / sponsor ID
- 1012.65
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 11 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 14 Oct 2013 (actual)
- Primary completion
- 20 Nov 2014 (actual)
- Study completion
- 21 Nov 2014 (actual)
- First posted
- 25 Oct 2013 (estimated)
- Results
- Posted 15 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combivent Respimat via tee adapter | Experimental | Drug: Combivent Respimat via tee adapterPatients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter |
| Combivent Respimat - ventilator adapter | Experimental | Drug: Combivent Respimat via ventilator adapterPatients (all); previously intubated and ventilated; in need of bronchodilation with /CVT-R via ventilator adapter |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (16 listed)
- 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:
- Active/unstable cardiac ischemia
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Combivent Respimat via tee adapterPatients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via tee adapter | Drug | Combivent Respimat via tee adapter |
| Combivent Respimat via ventilator adapterPatients (all); previously intubated and ventilated; in need of bronchodilation w/CVT-R via ventilator adapter | Drug | Combivent Respimat - ventilator adapter |
Primary outcome
Pre-dose Subtracted Maximum Measured Concentration of Ipratropium
Time frame: 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
Time frame: 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.
1 secondary outcome
Area Under the Concentration-time Curve Over the Time Interval From 0 to 6 Hour (AUC 0-6) of Ipratropium and Albuterol
Time frame: Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Clinical studies sponsored by Boehringer Ingelheim, phases I to IV, interventional and non-interventional, are in scope for sharing of the raw clinical study data and clinical study documents. Exceptions might apply, e.g. studies in products where Boehringer Ingelheim is not the license holder; studies regarding pharmaceutical formulations and associated analytical methods, and studies pertinent to pharmacokinetics using human biomaterials; studies conducted in a single center or targeting rare diseases (in case of low number of patients and therefore limitations with anonymization). For more details refer to: https://www.mystudywindow.com/msw/datatransparency
Related trials for Pulmonary Disease, Chronic Obstructive
RecruitingPhase 2
PRA-216 COPD Safety and Biomarker Study
Chronic Obstructive Pulmonary Disease (COPD)
RecruitingPhase 2
Phase 2b Efficacy and Safety Study of AERO-007, an Inhaled LABA+LAMA Combination for Nebulization Delivery in COPD Patients
COPD, Chronic Obstructive Pulmonary Disease (COPD)
Enrolling by invitationObservational study
Firefighter's Longitudinal Airway and Respiratory Exposome/Multiome Study (FLARES)
Anosmia, Chronic Obstructive Pulmonary Disease
Active, not recruitingPhase 2
A Study to Evaluate Solrikitug in Participants With COPD (ZION)
COPD
RecruitingPhase 2
To Evaluate the Effect of EXPD-101/FXS7553 Compared With Placebo in Patients With COPD Over 52 Weeks of Treatment
Chronic Obstructive Pulmonary Disease (COPD)
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Combivent Respimat via tee adapter and Combivent Respimat via ventilator adapter in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 10 Feb 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pre-dose Subtracted Maximum Measured Concentration of Ipratropium (time frame: Pre-treatment and 5 minutes (min), 15min, 30min, 60min, 2 hours (h), 4h, 6h after each inhalation of study medication). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2025.