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A clinical study to evaluate the safety, tolerability, and pharmacokinetics of the MMP 12 inhibitor FP- 025 after multiple oral ascending dose administration, and to evaluate the effect of food after a single oral dose administration in healthy subjects

Primary* To determine the safety and tolerability of multiple oral ascending doses of FP 025 in healthy subjects.Secondary* To determine the pharmacokinetics (PK) of FP 025 after multiple oral ascending doses of FP 025 in healthy subjects.* To…

A Two-Part, Double Blinded, Placebo Controlled, Crossover Repeated Stepped Infusion Dose Study of Respiratory Pharmacodynamics of GAL- 021 and Opioids (Protocol - GAL-021-104).

PrimaryPart 1: - To determine the respiratory response of low and high doses of GAL-021 in conjunction with a low dose of opioids and hypercapnia in healthy subjects. Part 2: - To determine the respiratory response of low and high doses of GAL-021…

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, 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, 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)

Primary objectiveTo evaluate the relationship of incremental doses of NVA237 q.d. and b.i.d. and their effect on trough FEV1 after 28 days of treatment, as defined by the percentage of the maximal effect that each dose achieves in relation to the…

Pharmacokinetics and dose-ranging of tiotropium inhalation solution delivered from the Respimat inhaler in patients with Chronic Obstructive Pulmonary Disease (COPD)

Tiotropium is available in the pharmacy as solution for inhalation (daily dose of 5 mcg) and as inhalation powder (daily dose of 18 mcg). The objective of the present study is to compare three doses of tiotropum solution for inhalation (daily dose…

The protective effect of levocetirizine on exercise induced airway obstruction in cold air.

Analyze the protective effect of levocetirizine (LEV), through the direct antagonism of airway H1 receptors and the inhibition of the release or production of other inflammatory mediators, against exercise induced airway obstruction.

Systemic effects in patients with COPD; training or treatment

To study the possible relation between systemic inflammation and oxidative stress and muscle breakdown using pharmacological interventions.

A MULTICENTRE, RANDOMISED, DOUBLE-BLIND, PLACEBO-CONTROLLED,;2-WAY CROSS-OVER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF;CHF 5259 (GLYCOPYRROLATE BROMIDE) pMDI ON TOP OF QVAR® pMDI;FOR THE TREATMENT OF PATIENTS WITH UNCONTROLLED ASTHMA;ON LOW-MEDIUM DOSE OF INHALED CORTICOSTEROIDS

The first objective is to evaluate the superiority of CHF 5259 pMDI (glycopyrrolate bromide) (50 µg total daily dose) versus placebo in terms of FEV1 AUC0-12h normalised by time on Day 42.Key Secondary objectiveTo evaluate the superiority of CHF…

A Double Blinded, Placebo Controlled, Crossover Infusion Study of Respiratory Pharmacodynamics of ENA-001 in Conjunction with Propofol, Hypoxia, and Hypercapnia

Primary Objectives:* To determine the safety and tolerability of ENA-001 in healthy subjects after low and high doses of ENA-001 under hypoxic and hypercapnic conditions in conjunction with low and high doses of propofol.* To determine the…

A Multicenter, Randomized, Sham-controlled Study to Evaluate Safety and Efficacy After Treatment with the Nuvaira* Lung Denervation System in Subjects with Chronic Obstructive Pulmonary Disease (COPD)

Primary objective: To evaluate the efficacy of targeted lung denervation (TLD) in addition to optimal medical care to reduce moderate or severe exacerbations and related hospitalizations, compared with optimal medical care alone, in subjects with…

The effect of FP-025, a MMP-12 inhibitor, on allergen induced airway responses, airway inflammation and aspects of airway remodeling in subjects with mild eosinophilic House Dust Mite (HDM)-allergic asthma

To determine the effect of FP-025 vs placebo on the allergen (HDM)-induced late asthmatic response expressed as FEV1 AUC3-8h in subjects with clinically stable, mild allergic asthma and blood eosinophilia.

Characterizing the Mechanism of Action of Metered Cryospray for the Treatment of Patients with
Chronic Obstructive Pulmonary Disease with Chronic Bronchitis

Overall aim: To evaluate the relationship between airway structure and function in patients with chronic bronchitis treated with metered cryospray (MCS).1) To identify the molecular and cellular targets of MCS treatment and determine the mechanistic…