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A randomised, double-blind, active-controlled parallel group study to evaluate the effect of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination compared with tiotropium on Chronic Obstructive Pulmonary Disease (COPD) exacerbation in patients with severe to very severe COPD.

The aim of this study is to demonstrate that once daily treatment with tiotropium + olodaterol fixed dose combination will reduce the number of exacerbations over tiotropium 5 µg monotherapy.A secondary aim of the study is an assessment of a…

An explorarory, 12 week, randomised, partially double-blinded, placebo-controlled parallel group trial to explore the effects of once daily treatments of orally inhaled tiotropium + olodaterol fixed dose combination or tiotropium (both delivered by Respimat® inhaler), supervised exercise training and behavior modification on exercise capacity and physical activity in patients with Chronic Obstructive Pulmonary Disease (COPD)

The primary objective is to confirm that bronchodilator monotherapy (tiotropium) plus behavioural modification, bronchodilator combination therapy (tiotropium + olodaterol FDC) plus behavioural modification, and bronchodilator combination therapy (…

A randomized, active-controlled, double-blind, double-dummy, parallel group design, multi-center trial to compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 µg delivered by the HandiHaler®.

To compare the efficacy and safety of 2.5 µg and 5 µg Tiotropium Inhalation Solution delivered by the Respimat® Inhaler with Tiotropium inhalation capsules 18 µg delivered by the HandiHaler®.

A 26-week treatment multi-center, randomized, doubleblind, parallel-group, placebo and active controlled (open label) study to assess the efficacy, safety and tolerability of QVA149 (110/50 Î*g q.d.) in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

Primary objective: To demonstrate the superiority of QVA 110/50 µg compared to both QAB149 150 µg and NVA237 50 µg in terms of trough FEV1 (mean of 23 h 15 min and 23 h 45 min post-dose) following 26 weeks of treatment in patients with moderate to…

A randomised, double-blind, parallel group study to assess the efficacy and safety of 52 weeks of once daily treatment of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 µg / 5 µg; 5 µg / 5 µg) (delivered by the RESPIMAT) compared with the individual components (2.5 µg and 5 µg tiotropium, 5 µg olodaterol) (delivered by the RESPIMAT) in patients with Chronic Obstructive Pulmonary Disease (COPD) [TOnadoTM 1]

The objective of this study is to assess the efficacy and safety of 52 weeks once daily treatment with orally inhaled tiotropium plus olodaterol fixed dose combination compared with the individual components tiotropium and olodaterol (delivered by…

A 64-week treatment, multi-center, randomized, double-blind, parallel-group, active controlled study to evaluate the effect of QVA149 (110/50 *g o.d.) vs NVA237 (50 *g o.d.) and open-label tiotropium (18 *g o.d.) on COPD exacerbations in patients with severe to very severe chronic obstructive pulmonary disease (COPD) (CQVA149A2304)

Primary objective: To demonstrate that QVA149 (110/50 *g o.d.) is superior to NVA237 (50 *g o.d.) with regard to the rate of moderate to severe COPD exacerbations during 64 weeks of treatmentSecondary objectives: To demonstrate that QVA149 (110/50 *…

A phase II/III, randomised, double-blind, placebo-controlled, parallel group trial to evaluate safety and efficacy of tiotropium inhalation solution (2.5 µg and 5 µg) administered once daily in the afternoon via Respimat® Inhaler for 12 weeks in patients 1 to 5 years old with persistent asthma

The primary objective of this trial is to evaluate the safety and efficacy of two doses of tiotropium inhalation solution delivered via the Respimat® inhaler once daily in the afternoon in patients (1 to 5 years old) with persistent asthma on top of…

A phase IIIb multicenter, 52 week treatment, randomized, blinded, double dummy, parallel group efficacy study comparing the effect of inhaled indacaterol 150 Î*g o.d. vs inhaled tiotropium 18 Î*g o.d. on lung function, rate of exacerbations and related outcomes in patients with COPD

This study is designed to demonstrate non inferiority of 150 *g o.d. of indacaterol versus tiotropium 18 *g o.d. with respect to 24 hour post dose (trough) FEV1 after 12 weeks of treatment.

Randomised, double-blind, placebo-controlled, 6 treatment, 4 period, incomplete cross-over trial to characterise the 24-hour lung function profiles of tiotropium + olodaterol fixed dose combination (2.5/5 µg, 5/5 µg), tiotropium (2.5 µg, 5 µg) and olodaterol (5 µg) (oral inhalation, delivered by the Respimat® Inhaler) after 6 weeks once daily treatment in patients with Chronic Obstructive Pulmonary Disease (COPD)

The primary objective of the trial is to determine the 24-hour FEV1-time profile of tiotropium + olodaterol FDC (2.5/5 µg, 5/5 µg), administered once daily by the RESPIMAT Inhaler, after 6 weeks of treatment.

A Randomised, Double Blind, Double Dummy, Parallel Group Study Comparing UMEC/VI (A Fixed Combination Of Umeclidinium and Vilanterol) With Tiotropium In COPD Subjects Who Continue To Have Symptoms on Tiotropium (DB2116960)

Efficacy and safety.

A randomised, double-blind, placebo- and active-controlled parallel group study to assess the efficacy of 12 weeks of once daily treatment of two doses of orally inhaled tiotropium + olodaterol fixed dose combination (delivered by the Respimat inhaler) in patients with Chronic Obstructive Pulmonary Disease (COPD)

The objective of the proposed study (1237.25) is to evaluate maximal treatment effect in FEV1 and SGRQ after 12-weeks treatment with two different doses of tiotropium + olodaterol FDC (5*g/ 5*g and 5*g/ 2.5*g) by comparison with placebo in patients…

A randomised, double-blind, 5 treatment arms, 4-period, incomplete cross-over study to determine the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (FDC) (2.5 / 5 µg; and 5 / 5 µg) (delivered by the Respimat® Inhaler) compared with tiotropium (5 µg), olodaterol (5 µg ) and placebo (delivered by the Respimat® Inhaler) on lung hyperinflation and exercise endurance time during constant work rate cycle ergometry in patients with Chronic Obstructive Pulm

The primary objective of this study is to compare the effects of orally inhaled tiotropium + olodaterol fixed dose combination (2.5 / 5 µg ; 5 / 5 µg) with tiotropium (5 µg), olodaterol (5 µg) and placebo on lung-hyperinflation and endurance time…

A randomized, double-blind, controlled, parallel group, 12-week treatment study to compare the efficacy and safety of the combination of indacaterol 150 µg once daily with open label tiotropium 18 µg once daily versus open label tiotropium 18 µg once daily in patients with moderate-to-severe chronic obstructive pulmonary disease.

To demonstrate the superiority of indacaterol 150 µg o.d. in combination with tiotropium 18 µg o.d. versus tiotropium 18 µg o.d. with respect to standardized area under the curve (AUC) for forced expiratory volume in 1 second (FEV1) between 5 min *…

Effect of inhalation of tiotropium once daily 18 mcg versus salmeterol twice daily 50 mcg on time to first exacerbation in COPD patients (a randomized, double-blind, double-dummy, parallel group, one year study)

To demonstrate superiority of tiotropium vs. salmeterol in reducing exacerbations which are an important patient outcome because they are a major cause of morbidity from COPD. In addition, they are associated with a more rapid decline in lung…

The effect of tiotropium-bromide on deep inspiration-induced bronchodilation and airway responsiveness in asthma.

1) To examine the effect of 3 weeks of 18*g tiotropium bromide once daily on the degree of bronchodilation following deep inspiration at a given level of bronchoconstriction.2) To examine the effect of 3 weeks of 18*g tiotropium bromide once daily…

inspiratory lung function parameters in subjects with a stable COPD

With intervention with bronchodilators (usual care bronchodilators for COPD subjects), in one study histamine and in one study steroids, we want to investigate the respons on inspiratory lung function parameter like the FIV1 and also investigate…

A phase III, randomized, double-blind, double-dummy, placebo-controlled, multicenter, 3-period incomplete block, multidose crossover study to determine the effect on lung function of indacaterol (150 and 300 mcg o.d.) in patients with moderate to severe COPD, using tiotropium (18 mcg o.d.) as an active control

The study is designed to compare the 24-h spirometry profile of two doses of indacaterol (150o.d. and 300 *g o.d.) with that of placebo (o.d.) and with tiotropium (18 *g o.d.) as an activecontrol in patients with COPD.

A randomised, double-blind, cross-over study to evaluate the effect of 6 weeks treatment of orally inhaled tiotropium + olodaterol fixed dose combination (5/5 µg) compared with tiotropium (5 µg), both delivered by the Respimat® Inhaler, on breathlessness during the three minute Constant Speed Shuttle Test (3min CSST) in patients with Chronic Obstructive Pulmonary Disease (COPD).

The primary objective of the study is to evaluate the effect of tiotropium + olodaterol FDCcompared to tiotropium monotherapy on the intensity of breathlessness during the 3min CSST.A secondary objective is to explore the relationship between…

A Phase IV, 12-week, randomised, double-blind, triple dummy study to compare single inhaler triple therapy, fluticasone furoate/umeclidinium/vilanterol (FF/UMEC/VI) with multiple inhaler therapy (budesonide/formoterol plus tiotropium) based on lung function and symptoms in participants with chronic obstructive pulmonary disease

Primary:To evaluate the effects of singleinhaler triple therapy (FF/UMEC/VI)compared to multiple inhaler triplecombination therapy withbudesonide/formoterol plus tiotropiumafter 12 weeks of treatment on lungfunctionOther:To evaluate the effects of…