A study to compare the efficacy and safety of different dosings of olodaterol administered with the Respimat® Inhaler in patients with moderate to severe asthma

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 180

Inclusion Criteria

Patients of either sex; aged =18 = 70 years; a current diagnosis and a documented
minimum 3 month history of asthma (GINA treatment steps 3 and 4); prebronchodilator FEV1=60% predicted and <90% predicted (ECSC); increase in FEV1 =12% and =200 ml 15 min. after 400 µg salbutamol (albuterol); stable on medium to high dose ICS or low to high dose ICS in combination with a LABA for at least 6 weeks prior to screening; stable on ICS mono component of the former fixed
LABA/ICS treatment for at least 48 hours prior to Visit 1b.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 170
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10

Exclusion Criteria

History of frequent seasonal exacerbations of asthma (defined as one or more seasonal exacerbations every year for the past three years), upper respiratory tract infection in the past 4 weeks prior to screening visit 1b, oral or other systemic corticosteroids in the past 6 weeks; patients with allergen desensitization therapy if started within two years, if they are not on an established maintenance regimen characterized by dose adjustments but no further increase to the tolerable maximum in the same course of immunotherapy.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method

Secondary Outcome Measures

Name	Time	Method

Related Trials

Phase II, Randomised, Double-Blind, Cross-over Study to Compare the 24-hour FEV1-time Profile of Orally Inhaled Olodaterol, delivered with the Respimat® Inhaler, after 3 Weeks of Olodaterol Once Daily 5 µg [2 actuations of 2.5 µg], Twice Daily 2.5 µg [2 actuations of 1.25 µg] and Placebo or after 3 Weeks of Once Daily 10 µg [2 actuations of 5 µg], Twice Daily 5 µg [2 actuations of 2.5 µg] and Placebo Administration in Patients with Moderate to Severe Persistent Asthma

Phase 1

Boehringer Ingelheim RCV GmbH & Co KG

Updated 6/30/2019

Phase II, Randomised, Double-Blind, Cross-over Study to Compare the24-hour FEV1-time Profile of Orally Inhaled Olodaterol, delivered withthe Respimat® Inhaler, after 3 Weeks of Olodaterol Once Daily 5 µg [2actuations of 2.5 µg], Twice Daily 2.5 µg [2 actuations of 1.25 µg] andPlacebo or after 3 Weeks of Once Daily 10 µg [2 actuations of 5 µg],Twice Daily 5 µg [2 actuations of 2.5 µg] and Placebo Administrationin Patients with Moderate to Severe Persistent Asthma

Boehringer Ingelheim RCV GmbH & Co KG

Updated 5/1/2012

Phase II, Randomised, Double-Blind, Cross-over Study to Compare the24-hour FEV1-time Profile of Orally Inhaled Olodaterol, delivered withthe Respimat® Inhaler, after 3 Weeks of Olodaterol Once Daily 5 µg [2actuations of 2.5 µg], Twice Daily 2.5 µg [2 actuations of 1.25 µg] andPlacebo or after 3 Weeks of Once Daily 10 µg [2 actuations of 5 µg],Twice Daily 5 µg [2 actuations of 2.5 µg] and Placebo Administrationin Patients with Moderate to Severe Persistent Asthma

Boehringer Ingelheim RCV GmbH & Co KG

Updated 5/1/2012

Phase 2, randomized, double-blind, two-way crossover, placebo-controlled clinical trial of the efficacy and safety of Mucuna pruriens seed extract in men with mild and mild to moderate erectile dysfunctio

Phase 2

Faculty of Medicine, Chiang Mai University

Updated 8/19/2024

A Randomized, Double-Blind, Crossover, Phase IIa Study Comparing a Single-Application TPM (registered trademark)/Oxycodone Patch versus Vehicle Patch on pain intensity in the Topical Treatment of Patients with Postherpetic Neuralgia

CompletedPhase 2

Phosphagenics Pty Ltd

Updated 1/13/2020

A Phase II, double-blind, randomized, cross-over, international,multicentre study to evaluate the analgesic efficacy of 3 weeks oraladministration of AZD4282 300 mg b.i.d. compared with placebo inposttraumatic neuralgia

Phase 1

AstraZeneca AB

Updated 10/3/2016

A Phase II, double-blind, randomized, cross-over, international,multicentre study to evaluate the analgesic efficacy of 3 weeks oraladministration of AZD4282 300 mg b.i.d. compared with placebo inpostherpetic neuralgia

Phase 1

AstraZeneca AB

Updated 10/3/2016

Clinical Trial, Phase II, randomized, double-blind, placebo-controlled, 1-way over with 2 treatment periods of 40 weeks duration.Applicants: Research Group CTS546. IBIMA. Regional University Hospital. Málaga.Subjects: Patients above 55 years with depressive disorders.

Hospital Regional Universitario. IBIMA

Updated 10/27/2014

A Phase 2, randomized, double-blind, cross-over study of S-600918 in subjects with refractory/unexplained chronic cough

CompletedPhase 2

Shionogi & Co., Ltd.

Updated 10/17/2023

Phase II, randomized, double-blind, crossover, placebo-controlled clinical trial to evaluate the efficacy and safety of Esketamine as an adjunct to standard care in patients with Obsessive-Compulsive Disorder- OCD

RecruitingPhase 2

Hospital Universitário Professor Edgard Santos

Updated 5/29/2023

A study to compare the efficacy and safety of different dosings of olodaterol administered with the Respimat® Inhaler in patients with moderate to severe asthma

Recruitment & Eligibility

Study & Design

Related Trials

Phase 2, randomized, double-blind, two-way crossover, placebo-controlled clinical trial of the efficacy and safety of Mucuna pruriens seed extract in men with mild and mild to moderate erectile dysfunctio

A Randomized, Double-Blind, Crossover, Phase IIa Study Comparing a Single-Application TPM (registered trademark)/Oxycodone Patch versus Vehicle Patch on pain intensity in the Topical Treatment of Patients with Postherpetic Neuralgia

A Phase II, double-blind, randomized, cross-over, international,multicentre study to evaluate the analgesic efficacy of 3 weeks oraladministration of AZD4282 300 mg b.i.d. compared with placebo inposttraumatic neuralgia

A Phase II, double-blind, randomized, cross-over, international,multicentre study to evaluate the analgesic efficacy of 3 weeks oraladministration of AZD4282 300 mg b.i.d. compared with placebo inpostherpetic neuralgia

Clinical Trial, Phase II, randomized, double-blind, placebo-controlled, 1-way over with 2 treatment periods of 40 weeks duration.Applicants: Research Group CTS546. IBIMA. Regional University Hospital. Málaga.Subjects: Patients above 55 years with depressive disorders.

A Phase 2, randomized, double-blind, cross-over study of S-600918 in subjects with refractory/unexplained chronic cough

Phase II, randomized, double-blind, crossover, placebo-controlled clinical trial to evaluate the efficacy and safety of Esketamine as an adjunct to standard care in patients with Obsessive-Compulsive Disorder- OCD

Clinical Trial Alerts

Clinical Trial Alerts