Respimat

Manufactured by Boehringer Ingelheim

Sourced in Germany

The Respimat is a compact, handheld soft mist inhaler device designed for the delivery of respiratory medications. It generates a slow-moving, soft mist to facilitate inhalation of the medication by the user.

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Lab products found in correlation

Handihaler, by Boehringer Ingelheim (2 mentions) Well counter, by Mirion Technologies (1 mentions) Ellipta, by GlaxoSmithKline (1 mentions) Breezhaler, by Novartis (1 mentions) Evohaler, by GlaxoSmithKline (1 mentions) Turbuhaler, by AstraZeneca (1 mentions)

5 protocols using respimat

COPD Tiotropium Monotherapy Trials

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All Boehringer Ingelheim-sponsored clinical trials of tiotropium monotherapy in COPD that met the criteria of !6 months' duration, placebo controlled, double blind, and in which SGRQ data were collected were included in the analyses. Patients were randomized to receive once-daily tiotropium 18 mg or placebo delivered via HandiHaler ® (Boehringer Ingelheim, Ingelheim am Rhein, Germany) in 10 trials and once-daily tiotropium 5 mg or placebo delivered via Respimat ® inhaler (Boehringer Ingelheim, Ingelheim am Rhein, Germany) in three trials. Based on past research, tiotropium doses delivered via HandiHaler and Respimat devices were considered comparable in terms of pharmacokinetics, efficacy, and safety [32e34]. In some trials, patients were also randomized to receive tiotropium 10 mg delivered via Respimat ® inhaler or an alternative active comparator; data from these treatment arms were not included in the analyses.
With the exception of two trials (one of 2 years' duration and one of 4 years' duration), the trials were 1 year or less in duration from start of treatment. Our analyses, focused on two time-points: 6 months and 1 year. The primary papers for each trial have been published [22e31] and their designs are summarized in Supplementary Table A1.

Tashkin D.P., Bateman E.D., Jones P., Zubek V.B., Metzdorf N., Liu D., Leonard T., Clerisme-Beaty E, & Wise R.A. (2016). Consistent improvement in health-related quality of life with tiotropium in patients with chronic obstructive pulmonary disease: Novel and conventional responder analyses. Respiratory medicine, 120.

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Tiotropium/Olodaterol Inhalation for COPD

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During screening, patients performed spirometry to determine study eligibility.
Eligible patients were randomized to receive one of three treatments:
tiotropium/olodaterol 2.5/5 μg, tiotropium/olodaterol 5/5 μg, or placebo, all
delivered once daily via the Respimat^® (Boehringer
Ingelheim International GmbH, Ingelheim am Rhein, Germany) inhaler (Figure 1).
Throughout the 12-week treatment period, trial medication was self-administered
by the patient once daily between 7 a.m. and 10 a.m.; on test days,
administration of trial medication was performed under research staff
supervision. Patients continued with inhaled corticosteroids if taken at
baseline. Open-label salbutamol (albuterol) was provided as rescue medication
throughout the study.
The study was conducted in accordance with the Declaration of Helsinki and the
International Conference on Harmonization Tripartite Guideline for Good Clinical
Practice. Before the study started, the protocol was reviewed and approved by
the Institutional Review Boards, and all patients provided written, informed
consent.

Maltais F., O’Donnell D., Gáldiz Iturri J.B., Kirsten A.M., Singh D., Hamilton A., Tetzlaff K., Zhao Y, & Casaburi R. (2018). Effect of 12 weeks of once-daily tiotropium/olodaterol on exercise endurance during constant work-rate cycling and endurance shuttle walking in chronic obstructive pulmonary disease. Therapeutic Advances in Respiratory Disease, 12, 1753465818755091.

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Radiolabeled Aerosol Delivery Evaluation

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Aerosol was generated by a soft mist inhaler that delivers a metered dose of aerosol (Respimat, Boehringer Ingelheim, Ingelheim, Germany). This aerosol generator is powered by a spring-driven piston within a small cylinder. The medication solution reservoir is a plastic cartridge. We found the Respimat system ideal for this study because it was possible to readily radio-label the test solution. The emitted dose, in terms of radioactive counts obtained from placing the absolute filters in a well counter (Capintec Ramsey New Jersey, USA), was shown to be reproducible. For each trial, the MDI canister was filled with 3.0 mL of normal saline radiolabelled with ^99mtechnetium (99m Tc). Two ‘puffs‘ from the Respimat were fired one after the other within 10 seconds into the Valved Holding Chamber (VHC) for each run and 3 runs were carried out for each study using either the soft or hard-surfaced “faces”.

Amirav I., Halamish A., Gorenberg M., Omar H, & Newhouse M.T. (2015). More Realistic Face Model Surface Improves Relevance of Pediatric In-Vitro Aerosol Studies. PLoS ONE, 10(6), e0128538.

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Olodaterol Dose-Ranging Phase III Trials

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Studies 1222.11 (ClinicalTrials.gov identifier NCT 00782210) and 1222.12 (ClinicalTrials.gov identifier NCT 00782509) were replicate, multicenter, multinational, randomized, double-blind, placebo-controlled, parallel-group Phase III trials (Figure 1). Following an initial screening visit and a 2-week baseline period, patients were randomized to receive olodaterol 5 μg or 10 μg once daily or placebo; randomization was stratified based on concomitant tiotropium use to ensure balanced assignment across treatment arms. Olodaterol was administered as two actuations of the Respimat^® inhaler (Boehringer Ingelheim, Ingelheim, Germany). The treatment period was 48 weeks, with a final follow-up 2 weeks later. Primary efficacy evaluations were carried out at 12 weeks, in line with US Food and Drug Administration requirements,16 and longer-term safety and efficacy end points were studied over the 48-week period.
The studies were carried out in accordance with the principles of the Declaration of Helsinki and the International Conference on Harmonisation Harmonised Tripartite Guideline for Good Clinical Practice, and written informed consent was obtained from each patient.

Ferguson G.T., Feldman G.J., Hofbauer P., Hamilton A., Allen L., Korducki L, & Sachs P. (2014). Efficacy and safety of olodaterol once daily delivered via Respimat® in patients with GOLD 2–4 COPD: results from two replicate 48-week studies. International Journal of Chronic Obstructive Pulmonary Disease, 9, 629-645.

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Comparing Inhaler Device Usability

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We compared five types of inhalers. The primary outcome was differences in the acceptable use ratio among inhaler devices. Secondary outcomes included differences in error correction after training, most common step of misuse, and factors affecting the accuracy of inhaler use. Further, we surveyed patient satisfaction with each device and found the most frequently error-prone steps. In this study, six inhaler device types were used by participants: Evohaler (GlaxoSmithKline, London, UK/Chiesi, Parma, Italy), Respimat (Boehringer Ingelheim, Ingelheim am Rhein, Germany), Turbuhaler (AstraZeneca, Lund, Sweden), Ellipta (GlaxoSmithKline), Breezhaler (Novartis, Basel, Switzerland), and Handihaler (Boehringer Ingelheim). However, Breezhaler and Handihaler were analyzed in the same group because of the similarities. Finally, five device types were compared.

Lee H.Y., Song J.H., Won H.K., Park Y., Chung K.B., Lim H.J., Ahn Y.M, & Lee B.J. (2020). Comparing Inhaler Use Technique Based on Inhaler Type in Elderly Patients with Respiratory Disease. Tuberculosis and Respiratory Diseases, 84(1), 46-54.

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