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The effect of two dosing regimens cefotaxime on the presence of potential pathogenic micro-organisms in airways.

Is treatment A: cefotaxime parenteral twice daily 1 gram during four days as effective as treatment B: cefotaxime parenteral four times daily 1 gram in preventing airway colonisation by potential pathogenic microorganisms.

Bronchiectasis and long term Azithromycin (AZM) Treatment:
a randomised placebo-controlled trial studying disease modifying effects of immunomodulating treatment

Primary objectives1. Does prolonged antibiotic treatment with AZM reduce the number of bacterial exacerbations in patients with bronchiectasis?2. Does treatment with AZM increase lung function parameters (Δ FEV1, Δ FVC )?Secondary objectives1. Is…

Self-reported influenza-like symptoms among elderly

Primary Objective: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported ILI.Secondary Objectives: • To determine the efficacy of 13vPnC in preventing a first episode of self-reported LRTI.• To determine the incidence…

Effect of intrapulmonary administration of recombinant human activated protein C on local coagulation and inflammation after bronchial instillation of lipopolysaccharide in humans

The primary objective is to determine the effect of locally administered rhAPC on LPS-induced lung inflammation and coagulation. By using measurements on cells harvested from bronchoalveolar lavage (BAL)-fluid and in BAL-fluid supernatants, we will…

A prospective study to evaluate the safety and efficacy of AdvaCoat Mx sinus gel for treatment of chronic rhinosinusitis without nasal polyps.

The purpose of the first part of the study is the evaluation of the first 9 subjects that will be conducted to confirm the 1.5 mL AdvaCoat Mx treatment volume per side as the desired volume for the expanded portion of the study. The purpose of the…

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 randomized, double-blind, placebo controlled, multicentre study to determine the effect of QVA149 on lungfunction in patients with Chronic Obstructive Pulmonary Disease (COPD).

The purpose of this study is to evaluate the effects of QVA149 300/50, a fixed dose combination of QAB149 300µg and NVA237 50µg, versus placebo and two doses of QAB149 300µg and 600µg, in terms of lung function in patients with moderate to severe…

RANDOMIZED CONTROLLED TRIAL (RCT) TO DETERMINE THE EFFICACY AND SAFETY OF AZITHROMYCIN (AZN) MAINTENANCE THERAPY FOR 6 MONTHS IN SUBJECTS WITH PCD - A DOUBLE-BLIND, PARALLEL GROUP STUDY

To determine if maintenance therapy with AZN will provide significant improvements in PCD lung disease, compared to placebo: reduction in respiratory system exacerbations and improvement in lung function, ventilation inhomogeneity, improvement in…

Stress ulcer prophylaxis with proton pump inhibitor (pantoprazole) in adult critically ill patients in the intensive care unit: A randomized, blinded, placebocontrolled trial

To assess the benefits and harms of SUP with PPI in adult, critically ill patients in the ICU.

Double-Blind, Randomized, Placebo-Controlled Phase IIa Clinical Trial to Investigate the Safety and Immunogenicity of RUTI® Therapeutic Vaccination in Patients with Multi-Drug Resistant Tuberculosis after successful intensive-phase treatment.

Primary endpoint: Evaluation of the safety of the novel anti-TB vaccine RUTI® (25*g FCMtb) in patients with MDR-TB favourably responding to second-line, standard MDRTB treatment through clinical, microbiological, and radiological response criteria.…

A Phase 2b, Randomized, Double-blind, Placebo-controlled Study to Evaluate the
Antiviral Activity, Clinical Outcomes, Safety, Tolerability, and Pharmacokinetics of Orally Administered ALS-008176 Regimens in Adult Subjects Hospitalized with Respiratory Syncytial Virus

Primary ObjectiveFor Part 1:The primary objective is to characterize the pharmacokinetics (PK) and to confirm the population PK (popPK) model derived from healthy volunteers in hospitalized adults who are infected with RSV.For Part 2:The primary…

A multiple-dose, subject- and investigator-blinded, placebo-controlled, parallel design study to assess the efficacy, safety, and tolerability of ACZ885 (canakinumab) in patients with pulmonary sarcoidosis

This study is designed as a proof-of-concept to assess if inhibition of IL-1* by canakinumabwill improve lung function in association with attenuation of tissue inflammation in patientswith chronic sarcoidosis, therefore allowing further development…

A Randomised, Double-Blind, Placebo-Controlled Multicentre Clinical Trial of Inhaled Molgramostim in Autoimmune Pulmonary AlveoLAr Proteinosis Patients

The main purpose of this study is to investigate how molgramostim improves the flow of oxygen from the lungs to the blood in patients with aPAP. The effect on lung function as a whole will also be studied, along with any improvement in the patients…

A randomized, double-blind, placebo-controlled, multicenter study of ensovibep (MP0420) in ambulatory adult patients with symptomatic COVID-19

The study has the purpose and rationale to establish the antiviral efficacy of ensovibep against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in humans, identify the optimal dose, and demonstrate its clinical value for treating COVID…

Effect of Bacillus Calmette-Guérin vaccination on the immunogenicity of the mRNA BNT162b2 COVID-19 vaccine in health care workers

To determine the impact of prior BCG vaccination on the duration of immunogenicity of the BioNTech/Pfizer mRNA COVID*19 vaccine.

RESPIRE - A Randomized, Double-Blind, Placebo-Controlled, Multi-Centre Clinical Trial to Evaluate the Safety and Efficacy of ATR-002 in Adult Hospitalized Patients with COVID-19

• To demonstrate the efficacy of ATR-002 versus placebo in addition to standard of care based on the clinical severity status in adult hospitalized patients with COVID-19• To show that ATR-002 in addition to standard of care shortens the time to…

Timing and sequence of vaccination against COVID-19 and Influenza

Aim 1. To study the impact of different sequences of combined influenza and SARS-CoV-2 vaccinations on immunological responses and sideeffects.Aim 2. To understand the immunological mechanisms that mediate the potential interference between…

A Phase II/III seamless, randomised, double-blind, placebo-controlled, parallel-group,
group-sequential study to evaluate efficacy, safety and tolerability of BI 767551 for the
treatment of symptomatic, non-hospitalized adults with mild to moderate COVID-19.

The overall objective of this trial is to evaluate the concept of pharmacological activity of BI 767551 in non-hospitalized patients with mild to moderate COVID-19 symptoms and to identify a potentially efficacious and safe dose regimen from Phase…

A double-blind, placebo-controlled randomized clinical trial with valsartan for PRevention of Acute rEspiraTORy dIstress syndrome in hospitAlized patieNts with SARS-COV-2 Infection Disease

To investigate the effect of the ARB valsartan in comparison to placebo on the occurrence of one of the following items, within 14 days of randomization:1) ICU admission; 2) Mechanical ventilation; 3) Mortality.

Bronchodilators for wheeze in young children presenting to primary care: a randomised, placebo-controlled, multicentre, parallel group trial.

What is the (cost-)effectiveness of salbutamol inhalations (4x200*g for 7 days) versus placebo in children aged 6-24 months presenting to their primary care physician with wheezing?