Abgeschlossene Studien

Offizieller Titel

Indikation

A multi-centre, double-blind, randomised, placebo-controlled, parallel-group study to evaluate the efficacy and safety of Birch Modified Allergen Tyrosine adsorbed + MPL in the prevention of seasonal symptoms in subjects with allergic rhinoconjunctivitis due to birch pollen

Birkenpollen Allergie

A multi-centre, randomised, double blind, placebo controlled study to determine the optimal effective and safe dose of Pollinex Quattro Grass 1.0 mL (Allergy Therapeutics, (UK) Ltd.) for the treatment of patients with seasonal allergic rhinoconjunctivitis due to grass pollen.

Gräserpollen Allergie

A randomized, double-blind, placebo-controlled (DBPC) parallel-group multi-centre study to assess the efficacy and safety of PURETHAL Mites subcutaneous immunotherapy (SCIT) in patients with allergic rhinitis/rhinoconjunctivitis (ARC) caused by house dust mite (HDM) allergy

Milben Allergie

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3b Study to Evaluate the Onset of Effect and Time Course of Change in Lung Function with Benralizumab in Severe, Uncontrolled Asthma Patients with Eosinophilic Inflammation

Asthma

A multicenter, randomized, double-blind, placebo-controlled 3-period complete cross-over study to assess the bronchodilator effects and safety of glycopyrronium bromide (NVA237) (25 µg and 50 µg

Asthma

PEANUT ALLERGY ORAL IMMUNOTHERAPY STUDY OF AR101 FOR DESENSITIZATION IN CHILDREN AND ADULTS (THE PALISADE STUDY

Erdnuss Allergie

A mul+C44:F44ti-center, randomized, 12-week treatment, double blind study to assess the efficacy and safety of QMF149 (150/80 microgram) compared with MF Twisthaler® (200 microgram) in adult and adolescent patients with asthma

Asthma

A phase IIa, randomized, double-blind, placebo controlled, parallel group study to assess the safety and efficacy of subcutaneously administered BI 655066/ABBV-066 (risankizumab) as add-on therapy over 24 weeks in patients with severe persistent asthma.

Asthma

A multi-center, randomized, double-blind, placebo controlled, parallel group study to compare cessation versus continuation of long-term mepolizumab treatment in patients with severe eosinophilic asthma (201810)

Asthma

A 52-week, multicenter, randomized, double-blind, placebo-controlled study to assess the efficacy and safety of QAW039 when added to existing asthma therapy in patients with uncontrolled severe asthma.

Asthma

Open label phase II multicenter clinical trial to evaluate safety during accelerated dose escalation of an allergoid birch pollen preparation in patients with IgE mediated allergic rhinitis or rhinoconjunctivitis with or without controlled bronchial asthma

Birkenpollen Allergie

A 52 week, randomized, double blind, multinational, multicentre, active controlled, 3-arm parallel group trial comparing CHF 5993 200/6/12.5 µg pMDI alone or on top of open-label tiotropium 2.5 µg Respimat® in patients with asthma uncontrolled on high doses of inhaled corticosteroids in combination with long-acting ß2-agonists

Asthma

A multi-centre, double-blind, placebo-controlled study to explore the safety and efficacy of Birch Modified Allergen Tyrosine adsorbed + MPL (POLLINEX® Quattro Plus 1.0 mL Birch [PQ Birch]) in subjects with seasonal allergic rhinoconjunctivitis due to birch pollen.

Birkenpollen Allergie

A Multi-Center, Randomized, Double-Blind, Placebo-Controlled study to investigate the efficacy and safety of 52 weeks treatment with QGE031 s.c. in Asthma Patients not adequately controlled by medium- or high-dose ICS plus LABA with or without OCS

Asthma

A multicenter, randomized, open-label clinical trial to evaluate safety and tolerability of a year-round initiation of specific immunotherapy with an aluminum hydroxide adsorbed allergoid preparation of 6-grasses in patients with moderate to severe seasonal rhinitis or rhinoconjunctivitis with or without controlled asthma.

Gräserpollen Allergie

A double-blind, placebo controlled, randomized crossover trial to characterize the mucolytic effectiveness of Tacholiquin® in chronic bronchitis

Bronchitis

An open-label, multi-center, extension study to evaluate the long-term safety of subcutaneous 240mg QGE031 given every 4 weeks for 52 weeks in allergic asthma patients who completed study CQGE031B2201

Asthma

A randomized, parallel group study to evaluate the effect of Umeclidinium (UMEC) added to Inhaled corticosteroid/ long-acting beta-agonist combination therapy in subjects with Chronic Obstructive Pulmonary Disease COPD

COPD

Randomised, double-blind, 56 week placebo-controlled, parallel group, multicentre, phase 3 study to evaluate the efficacy and safety of 2 doses of benralizumab in patients with moderate to very severe COPD with a history of exacerbations

COPD

Study DB2116961, A Multicentre, Randomised, Blinded, Parallel Group Study to Compare UMEC/VI (Umeclidinium/Vilanterol) in a Fixed Dose Combination With Indacaterol Plus Tiotropium in Symptomatic Subjects With Moderate to Very Severe COPD

COPD

A Multicenter, Double-blind, Randomized, Parallel Group, Phase 3 Safety Extension Study to Evaluate the Safety and Tolerability of Benralizumab (MEDI-563) in Asthmatic Adults and Adolescents on Inhaled Corticosteroid Plus Long-acting β2 Agonist (BORA)

Asthma

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

COPD

A Multicenter, Randomized, Double-blind, Parallel Group, Placebo-controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Benralizumab in Adult Patients with Mild to Moderate Persistent Asthma

Asthma

A multi-centre, double-blind dose-ranging study to evaluate the efficacy and safety/tolerability of Birch Modified Allergoid Tyrosine-adsorbed + MPL (POLLINEX Quattro®Birch) in Subjects with seasonal allergic hinoconjunctivitis due to birch pollen

Birkenpollen Allergie

A randomized, multi-center, double-blind, doubledummy, parallel group study to evaluate the efficacy and safety of umeclidinium bromide/vilanterol compared with fluticasone propionate/salmeterol over 12 weeks in subjects with COPD

COPD

A Multi-Center, Randomized, Double Blind, Placebo and Active-Controlled study with exploratory dose-ranging, to investigate the efficacy and safety of 16 weeks treatment with subcutaneous QGE031

Asthma

A multicentre, randomised, double-blind, parallel group, placebo-controlled, Phase 3 study to evaluate the efficacy and safety of benralizumab in asthmatic adults and adolescents inadequatley controlled on inhaled corticosteroid plus long-acting beta2 agonist (CALIMA)

Asthma

A randomized, double-blind, placebo-controlled study to determine safety, tolerability and the optimal effective dose of SUBLIVAC FIX Phleum pratense in patients with allergic rhinitis/rhinoconjunctivitis caused by grass pollen

Gräserpollen Allergie

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

COPD

A 26-week treatment, multicenter, randomized, parallel group, blinded study to assess the efficacy and safety of QVA149 (110/50 µg q.d.) in patients with moderate to severe chronic obstructive pulmonary disease (COPD), using tiotropium plus formoterol as an active control

COPD

A 12-week treatment, randomized, blinded, double-dummy, parallel-group study to assess the efficacy, safety, and tolerability of NVA237 (50 μg o.d.) compared to tiotropium (18 μg o.d.) in patients with chronic obstructive pulmonary disease (COPD)

COPD

Clinical and immune modifying capacity of Broncho-Vaxom® tested by LPS challenge in healthy volunteers A randomized double-blind placebo-controlled trial

Bronchitis / Gesund

A randomised, double- blind, 2 way cross-over study to determine 24-hour FEV1-time profile of inhaled tiotropium, delivered via the Respimat® inhaler, after 4 weeks of once daily [5 µg in the evening (2 actuations of 2.5 µg)] or twice daily [2.5 µg in the morning and evening (2 actuations of 1.25 µg)] administration in patients with moderate persistent asthma.

Asthma

HZC113109: A 12-Week Study to Evaluate the 24-Hour Pulmonary Function Profile of Fluticasone Furoate /Vilanterol (FF/VI) Inhalation Powder 100/25mcg Once Daily Compared with Fluticasone Propionate/Salmeterol Inhalation Powder 250/50mcg Twice Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

COPD


A 26-week treatment, multi-center, randomized, double-blind, double dummy, parallel-group study to assess the efficacy, safety and tolerability of QVA149 compared to fluticasone/salmeterol in patients with moderate to severe chronic obstructive pulmonary disease

COPD

A multi-center, randomized, open-label, parallel-group, repeat dose study in asthma patients with elevated eosinophils. Eligible subjects will receive 3 doses (28 days apart) of mepolizumab given intravenous (IV) or subcutaneously (SC). Blood samples for safety, pharmacokinetics (PK), pharmacodynamics (PD) and immunogenicity analysis, as well as safety/tolerability assessments will be collected throughout the study

Asthma

A 12-Week Study to Evaluate the 24 Hour Pulmonary Function of Fluticasone Furoate (FF)/Vilanterol (VI) Inhalation Powder (FF/VI Inhalation Powder) Once Daily Compared with Salmeterol/Fluticasone Propionate (FP) Inhalation Powder Twice Daily in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

COPD

A multicentre, randomised, double-blind, placebo-controlled, parallel group, dose ranging study to determine the effect of mepolizumab on exacerbation rates in subjects with severe uncontrolled refractory asthma.

Asthma

Randomised, double-blind, double-dummy, placebo-controlled, parallel group study to assess the efficacy and safety of 6 weeks of oral BI 671800 ED 400 mg b.i.d., Montelukast 10 mg q.d., or placebo in symptomatic asthma patients on fluticasone propionate MDI

Asthma

Randomised double blind placebo controlled pivotal study to evaluate efficacy and safety of rPhleum in adult and adolescent patients suffering from rhinoconjunctivitis +/- controlled Asthma

Asthma

A randomized, double-blind, placebo-controlled, 2-period, cross-over study to assess the efficacy and safety of differing doses of NVA237 administered either once daily or twice daily, in patients with moderate to severe chronic obstructive pulmonary disease (COPD)

COPD

A Multi-Center, Randomized, Double Blind, Placebo-Controlled, ‘add-on’ study to investigate the efficacy and safety of 24 weeks intravenous treatment with QAX576 in patients (≥18-75 years) with persistent asthma not adequately controlled with inhaled corticosteroids and long acting β2-agonists

Asthma

A phase III randomized, partially-blind, controlled, multi-country, multi-centre study to evaluate the immunogenicity, reactogenicity and safety of GSK Biologicals’ quadrivalent influenza vaccine D-QIV (GSK2321138A) and to evaluate the clinical consistency of three production lots of D-QIV in terms of immunogenicity, when administered intramuscularly to adults 18 years of age and older.

Influenza / Gesund

A randomised, double-blind, placebo-controlled (with rescue medication), parallel group multicentre study of Fluticasone Furoate/GW642444 Inhalation Powder and Fluticasone Furoate Inhalation Powder alone in the treatment of persistent asthma in adults and adolescents.

Asthma

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

COPD

A prospective, randomized, open, multi-centre study to assess safety of PURETHAL Grasses given with a rush induction schedule to patients with allergic rhinoconjunctivitis.

Gräserpollen Allergie

A randomized, double-blind, placebo-controlled study to demonstrate the efficacy of Xolair in an allergen bronchoprovocation study in two asthmatic populations defined by serum IgE concentrations


Asthma