CLINICAL TRIALS PROFILE FOR COMBIVENT RESPIMAT
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All Clinical Trials for COMBIVENT RESPIMAT
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT00400153 ↗ | Respimat® Combivent Trial in Chronic Obstructive Pulmonary Disease (COPD) | Completed | Boehringer Ingelheim | Phase 3 | 2006-11-01 | The primary objective of this study is to compare the effect of ipratropium bromide/salbutamol inhalation spray combination administered by the Respimat® inhaler (20 mcg/100 mcg), ipratropium bromide inhalation spray administered by the Respimat® inhaler (20 mcg), and COMBIVENT® MDI administered q.i.d on FEV1 at intervals over a treatment period of 12 weeks in patients with COPD. Specifically, non-inferiority of Combivent Respimat® to COMBIVENT® MDI in FEV1 AUC from 0 to 6 hours , superiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 0 to 4 hours, and non-inferiority of Combivent Respimat® to Atrovent Respimat® monotherapy in FEV1 AUC from 4 to 6 hours will be analyzed. In addition, steady state pharmacokinetics over one dosing interval following 4 weeks of therapy will be characterized in a subgroup of patients. |
| NCT00818454 ↗ | 4 Week 2 Way Crossover Double Blind Treatment Phase With Combivent CFC Versus Albuterol Followed by a 4 Week Open Label Combivent Respimat When All Drugs Are Used for Symptom Relief as Needed in Pts With Moderate to Severe Asthma | Completed | Boehringer Ingelheim | Phase 2 | 2008-12-01 | The primary goal of this trial is to compare the efficacy and safety of COMBIVENT CFC MDI with albuterol HFA MDI, the current standard reliever medication in asthma. In the first cross-over part of the study (Treatment Phases 1 and 2) the marketed product, COMBIVENT CFC MDI will be used. In the second, parallel group part of the trial (Treatment Phase 3) COMBIVENT RESPIMAT will be tested for acute bronchodilator efficacy in a blinded manner at the clinic visits. During the third 4-week treatment phase open label COMBIVENT RESPIMAT will be used for symptom relief as needed. |
| NCT01019694 ↗ | Combivent Respimat 1-year Safety Study in Patients With Chronic Obstructive Pulmonary Disease | Completed | Boehringer Ingelheim | Phase 3 | 2009-11-01 | The primary objective of this study is to evaluate long-term safety and patient acceptability of COMBIVENT RESPIMAT Inhalation Spray as compared to the COMBIVENT Inhalation Aerosol Chlorofluorocarbon-Metered Dose Inhaler (CFC-MDI) and the free combination of ATROVENT Hydrofluoroalkane (HFA) and albuterol Hydrofluoroalkane (HFA) inhalation aerosols. |
| NCT01969539 ↗ | Ventilator Adapters for Combivent Respimat | Terminated | Boehringer Ingelheim | Phase 4 | 2013-10-01 | 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. |
| NCT02177253 ↗ | Ipratropium Bromide/Salbutamol Delivered by the Respimat® Inhaler Compared to Ipratropium Bromide Respimat®, COMBIVENT® Inhalation Aerosol and Placebo in Adults With Chronic Obstructive Pulmonary Disease | Completed | Boehringer Ingelheim | Phase 3 | 2002-10-01 | The primary objective of this study was to compare the long-term (12-week) bronchodilator efficacy and safety of ipratropium bromide / salbutamol combination administered by the Respimat® 40 mcg / 200 mcg (one inhalation q.i.d.) to COMBIVENT Inhalation Aerosol (two inhalations q.i.d.), ipratropium bromide Respimat® (one inhalation q.i.d.) and Placebo formulations of each in patients with Chronic Obstructive Pulmonary Disease (COPD). An additional objective was to show the superiority of Combivent Respimat as compared to ipratropium bromide (40 mcg) Respimat. Steady state pharmacokinetics over one dosing interval following four weeks of therapy were also characterized. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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