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Randomized, double-blind, placebo-controlled, multicenter study comparing Ciprofloxacin DPI 32.5 mg BID intermittently administered for 28 days on / 28 days off or 14 days on / 14 days off versus placebo to evaluate the time to first pulmonary exacerbation and frequency of exacerbations in subjects with non-cystic fibrosis bronchiectasis.

Page 18 of the protocol (v1.0, 4-Nov-2013):The primary objectives of this study are:- To evaluate the efficacy of ciprofloxacin DPI administered BID intermittently for 28 days on study treatment / 28 days off study treatment or 14 days on study…

A randomised, double-blind, placebo-controlled, parallel-group, multi-centre 24-week study to evaluate the efficacy and safety of mepolizumab adjunctive therapy in subjects with severe
eosinophilic asthma on markers of asthma control (study 200862, MUSCA)

Primary: To evaluate the efficacy of mepolizumab 100 mg subcutaneous (SC) every 4 weeks versus placebo on health-related quality of life (HR-QoL) in adult and adolescent subjects with severe eosinophilic asthma. Secondary: To assess the effects of…

A Multicentre, Randomized, Double-blind, Parallel Group, Placebo Controlled, Phase 3 Study to Evaluate the Efficacy and Safety of Tralokinumab in Reducing Oral Corticosteroid Use in Adults and Adolescents with Oral Corticosteroids dependent Asthma (TROPOS)

Primary objective:• To evaluate the effect of tralokinumab compared to placebo in reducing the prescribed, OCS maintenance dose in adult and adolescent subjects with asthma requiring chronic treatment with maintenance OCS in addition to ICS/LABA.…

A RANDOMISED, DOUBLE-BLIND, DOUBLE-DUMMY, ACTIVE-CONTROLLED STUDY EVALUATING THE EFFICACY, SAFETY AND TOLERABILITY OF TWICE-DAILY ACLIDINIUM BROMIDE /FORMOTEROL FUMARATE COMPARED WITH TWICE-DAILY SALMETEROL/FLUTICASONE PROPIONATE FOR 24-WEEKS TREATMENT IN SYMPTOMATIC PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)

Section 7 of the protocol:7. TRIAL OBJECTIVES AND PURPOSE* To assess the long term bronchodilator efficacy of Aclidinium bromide/Formoterol fumarate, administered twice a day, compared to Salmeterol/Fluticasone propionate (SeretideTM AccuhalerTM) in…

A 16-Week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to evaluate the
Efficacy and Safety of Reslizumab (0.3 or 3.0 mg/kg) as Treatment for Patients (12-75 Years of Age) with Eosinophilic Asthma.

The primary objective of this study is to determine whether reslizumab, at a dosage of 0.3 or 3.0 mg/kg administered once every 4 weeks for a total of 4 doses, is more effective than placebo in improving lung function in patients with eosinophilic…

Influence of macrolide maintenance therapy and bacterial colonisation on exacerbation frequency and progression of COPD, a randomized double-blind placebo-controlled trial

To assess whether maintenance treatment with macrolide antibiotics in COPD patients with three or more exacerbations in the previous year can decrease the exacerbation rate in the year of treatment.

A Phase 3, Double-Blind, Multicenter, Randomized, Placebo-Controlled Trial Evaluating Repeated Courses of Aztreonam for Inhalation Solution/Aztreonam 75 mg Powder and Solvent for Nebuliser Solution in Subjects with non-CF Bronchiectasis and Gram-Negative Endobronchial Infection

This study is designed to assess the safety and efficacy of aztreonam for inhalation solution/aztreonam 75 mg powder and solvent for nebuliser solution (AZLI) in subjects with non-CF bronchiectasis and gram-negative endobronchial infection.

MEA115575: A Randomised, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study of Mepolizumab Adjunctive Therapy to Reduce Steroid Use in Subjects with Severe Refractory Asthma (MEA115575)

Primary: To compare the effects of mepolizumab adjunctive therapy with placebo on reducing the use of maintenance oral corticosteroids (OCS).Secondary: Safety, tolerability, other efficacy parameters, quality of life.

Efficacy and safety of aclidinium bromide/formoterol fumarate fixed-dose combinations compared with individual components and placebo when administered to patients with stable chronic obstructive pulmonary disease (COPD).

• To assess the long-term bronchodilation of aclidinium/formoterol FDCs compared to individual components and placebo, when administered twice daily via inhalation to COPD patients.• To assess the benefits of aclidinium/formoterol FDCs in COPD…

The effect of azithromycin in patients with COPD and chronic productive cough.

To determin the effect of low dose azithromycin ( 3 times a week 250 mg) on the cough related health status in patients with COPD and chronic productive cough.In a randomized controlled study.

A 52-week treatment, multicenter, randomized, doubleblind,
double dummy, placebo-controlled, parallel-group
study to assess the efficacy, safety and tolerability of
indacaterol (300 & 600 µg o.d.) in patients with chronic
obstructive pulmonary disease, using formoterol (12 µg
b.i.d.) as an active control

To assess indacaterol (300 and 600 ug once daily via SDDPI) superiority in patients with COPD as compared to placebo with respect to 24 h post dose (through) FEV1 after 12 weeks of treatment.

The effect of treatment with high dose vitamin D on airway inflammation in non-atopic asthma.

Primary Objective: To investigate the effect of supplementation of a single high dose of vitamin D (400.000 IU) on 1. the percentage of neutrophils in induced sputum, in non-atopic asthmatic patients with neutrophilic airway inflammation (…

Randomised, double-blind, chronic dosing (56 week) placebo-controlled, parallel group, multicentre, phase 3 study to evaluate the efficacy and safety of 2 doses of benralizumab (MEDI-563) in patients with moderate to very severe Chronic Ostructive Pulmonary Disease (COPD) with a history of COPD exacerbations (GALATHEA)

Primary Objective:To evaluate the efficacy and safety of 2 doses of benralizumab in patients with moderate to very severe Chronic Pulmonary Disease (COPD).Secondary Objectives:To evaluate the effect of two doses of benralizumab on:* health status/…

A Phase 3, 24-Week Double-Blind, Placebo-Controlled, Parallel-Group, Efficacy and Safety Study of Reslizumab Subcutaneous Dosing (110 mg Every 4 weeks) in Patients with Oral Corticosteroid Dependent Asthma and Elevated Blood Eosinophils

The primary objective of this study is to determine the ability of reslizumab (110 mg) administered subcutaneously (sc) once every 4 weeks to produce a corticosteroid-sparing effect (as demonstrated by percent reduction in daily OCS use) in patients…

Long-term inhaled nebulized tobramycin in patients with non-cystic fibrosis bronchiectasis. A randomized placebo controlled trial. The BATTLE study Bronchiectasis And Tobramycin SoluTion InhaLation ThErapy.

The primary outcome of the study is a 50% reduction in exacerbation rate in patients using TIS once daily (OD). Secondary outcome parameters are lung function (FEV1, FVC), QoL (QOL-B), LTRI-VAS, Leicester cough score), bacterial load in sputum and…

A 2-treatment period, randomized, placebo-controlled, multicenter parallel-group study to assess the safety of QAW039 when added to existing asthma therapy in GINA steps 3, 4 and 5 patients with uncontrolled asthma

The overall purpose of this study is to provide long-term safety data for fevipiprant (QAW039) (150 mg once daily and 450 mg once daily),compared with placebo, when added to the Global Initiative for Asthma (GINA) steps 3, 4, and 5 standard-of-care…

A Randomized, Double-blind, Placebo-controlled, Parallel-group, 52-week
Pivotal Study to Assess the Efficacy, Safety, and Tolerability of Dupilumab in
Patients with Moderate-to-severe Chronic Obstructive Pulmonary Disease
(COPD) with Type 2 inflammation

- The purpose of this study is to evaluate the efficacy of the study drug to lung function, exacerbations and quality of life with patients with COPD. The safety and tolerability of the study drug is monitored as part of this study.

A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Assess the Efficacy, Safety, and Tolerability of Brensocatib Administered Once Daily for 52 Weeks in Subjects with Non-Cystic Fibrosis Bronchiectasis - The ASPEN Study

1. To evaluate the effect of brensocatib at 10 mg and 25 mg compared with placebo on the rate of pulmonary exacerbations (PEs) over the 52-week treatment period

Randomized, double-blind, placebo-controlled, parallel-group Phase 3 study to evaluate the efficacy, safety, and tolerability of SAR440340/REGN3500/itepekimab (anti-IL-33 mAb) in patients with moderate-to-severe chronic obstructive pulmonary disease (COPD)

This study has been transitioned to CTIS with ID 2024-512012-21-00 check the CTIS register for the current data. Primary objectivePrimary population (former smokers cohort):- Evaluate the efficacy of itepekimab compared with placebo on the…

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

In patients with severe asthma and high eosinophil counts (>=250 cells/µl) receiving SoC asthma therapy, to demonstrate the efficacy (as measuredby rate of moderate-to-severe asthma exacerbations) of at least one dose level of QAW039 (150 mg…