Clinical trials: sponsored by Chiesi Farmaceutici S.p.A.
COPD
Study to Investigate the Pharmacokinetics of CHF 6001 DPI Administered Via Nexthaler® Device or the Capsule for Oral Inhalation Via Aerolizer® Device
The purpose of this study is to compare the systemic availability to CHF 6001 after a single dose of CHF 6001 administered using the multi-dose NEXThaler® device or the single-dose capsule inhaler Aerolizer®.
- Trial name
- NCT02119247
- Testing
- CHF 6001 dry powder for inhalation via NEXThaler®, CHF 6001 DPI capsules for inhalation via Aerolizer
- Where
- Belgium
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Determining the Optimal Adenosine Provocation Test
Asthma is a frequently occurring inflammatory lung disease that affects the whole bronchial tree including the small airways (<2mm).
- Trial name
- impact (NCT01610921)
- Testing
- Bronchial provocation test
- Where
- 2 sites in Netherlands
- Volunteers
- 11 people
- Sponsor
- University Medical Center Groningen
Asthma
Small Airways Involvement in Smoker Asthmatic Patients: a Pilot Study
Asthma is an inflammatory disease affecting the whole respiratory system, from central to peripheral airways. Anti-inflammatory treatment with inhaled corticosteroids (ICS), with or without long-acting β2-adrenoceptor agonists…
- Trial name
- NCT01620099
- Testing
- Extrafine treatment (Clenilexx(R) or Foster(R))
- Where
- 2 sites in Germany, Italy
- Volunteers
- 60 people
- Sponsor
- Università degli Studi di Ferrara
Alzheimer's Disease
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Prolonged Open Label Extension Phase
The purpose of the study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.
- Trial name
- CT04 POLEP (NCT01602393)
- Testing
- CHF 5074 1x, CHF 5074 2x, CHF 5074 3x
- Where
- 5 sites in United States, Italy
- Volunteers
- 51 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Alzheimer's Disease
Evaluation of Safety & Tolerability of Multiple Dose Regimens of CHF 5074 and Exploration of Effects on Potential Markers of Clinical Efficacy in Patients With Mild Cognitive Impairment - Open Label Extension (CT04 OLEP)
The purpose of this study is to evaluate the safety and tolerability of ascending oral doses of CHF 5074 after prolonged administration to patients with mild cognitive impairment.
- Trial name
- NCT01421056
- Testing
- CHF 5074 1x, CHF 5074 2x, CHF 5074 3x
- Where
- 6 sites in United States, Italy
- Volunteers
- 74 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Cystic Fibrosis
Retrospective Observational Study to Compare Cystic Fibrosis Patients in Two Decades Before and After 2000
The purpose of this study is to describe two cohorts of cystic fibrosis patients treated in 2 different decades in terms of FEV1 (Forced Expiratory Volume in one second) maintenance.
- Trial name
- MAESTRALE (NCT01651455)
- Where
- Italy
- Volunteers
- 92 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
COPD, Emphysema
Evaluate the Effects of Formoterol and Beclomethasone Dipropionate Combination Therapy on Small Airways Function
Inuvair® is a novel fixed combination product used in the treatment of asthma and under clinical development for the treatment of COPD.
- Conditions
- COPD, Emphysema, Small Airway Disease
- Trial name
- NCT01466712
- Testing
- Tiotropium + formoterol/beclometasone
- Where
- Belgium
- Volunteers
- 20 people
- Sponsor
- KU Leuven
Asthma
Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
To evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL; Seretide® 125) in matched asthma…
- Trial name
- REACH (NCT01908075)
- Testing
- FP/SAL, BDP/FOR
- Volunteers
- 194,723 people
- Sponsor
- Research in Real-Life Ltd
Asthma
Development of Small Airway Disease Questionnaire
The aim of this study is to develop a patient reported outcome tool specific to small airways disease, which assesses symptoms and signs of small airways disease and may help in addition to FEF50% to discriminate between…
- Trial name
- SADQ (NCT01360294)
- Where
- Netherlands
- Volunteers
- 65 people
- Sponsor
- University Medical Center Groningen
Hypertension
A Study to Evaluate the Effects of Manidipine Versus Amlodipine and the Combination of Manidipine Plus Delapril Versus Amlodipine Plus Delapril on Intraglomerular Pressure in Hypertensive Patients
Eight-week multi-national, multicenter, randomized, double blind, active control, two arms, parallel groups study with a 4-week single drug treatment (manidipine or amlodipine) phase followed by a 4-week combination treatment…
- Trial name
- NCT00627952
- Testing
- amlodipine 10 mg, manidipine 20 mg, amlodipine 5 mg + delapril 30 mg
- Where
- Germany
- Volunteers
- 100 people
- Sponsor
- University of Erlangen-Nürnberg Medical School
Cystic Fibrosis
Tobramycin 300 mg Once-a-day (o.d.) Aerosol in Adults With Cystic Fibrosis
The study will include 10 adult patients with cystic fibrosis. The aim of the study is to evaluate whether Tobramycin 300 mg aerosol once-a-day for 28 days can reduce the bacterial load in the airways.
- Trial name
- NCT01608555
- Testing
- tobramycin
- Where
- Italy
- Volunteers
- 10 people
- Sponsor
- University of Milan
Chronic Obstructive Pulmonary Disease
Study to Assess the Effect of Formoterol and Beclomethasone Dipropionate in Patients With Chronic Obstructive Pulmonary Disease (COPD)
The objective of this study is to evaluate the effect of the combination of formoterol and beclometasone dipropionate on central and peripheral airway dimensions in COPD patients using Computational Fluid Dynamics (CFD).
- Trial name
- NCT01204034
- Testing
- Inuvair
- Where
- Belgium
- Volunteers
- 29 people
- Sponsor
- University Hospital, Antwerp
Asthma
Real-world Effectiveness of Combination Therapies in Primary Care Asthma Management
The purpose of this study is to evaluate whether beclomethasone dipropionate / formoterol (BDP/FOR; Fostair® 100/6) is at least equivalent in terms of exacerbation prevention to fluticasone dipropionate / salmeterol (FP/SAL…
- Trial name
- Fos/Ser_switch (NCT01242098)
- Testing
- Fixed dose combination salmeterol / fluticasone, Fixed-dose combination beclometasone dipropionate / formoterol
- Where
- United Kingdom
- Volunteers
- 137 people
- Sponsor
- Research in Real-Life Ltd
Asthma
Prevalence and Reversibility of Lung Hyperinflation in Asthma
The aim of this observational study is to evaluate the pulmonary hyperinflation and its immediate reversibility to a short acting beta2 agonist test in uncontrolled persistent asthmatic patients with dyspnea.
- Trial name
- Dist'air2 (NCT01573364)
- Where
- France
- Volunteers
- 450 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Respiratory Distress Syndrome, Newborn
Observational Study on the Prophylactic Use of Curosurf in Neonatal Respiratory Distress Syndrome (RDS)
The aim of Alizé is to describe a population of premature babies (gestational age (GA) < 32 weeks) in real life situation and the management of RDS.
- Trial name
- NCT01102543
- Where
- France
- Volunteers
- 972 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Formoterol-HFA 3-month Study in Chronic Obstructive Pulmonary Disease (COPD) Patients
The purpose of this study is to demonstrate the clinical equivalence of formoterol-HFA pMDI 12µg/actuation administered twice daily to formoterol DPI 12µg/capsule delivered by the Aerolizer inhaler and administered twice daily in…
- Trial name
- NCT00972140
- Testing
- Formoterol
- Where
- Poland
- Volunteers
- 457 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Croup
Efficacy of Nebulized Beclomethasone Dipropionate (BDP) in the Treatment of Moderate Croup
Acute laryngotracheobronchitis, better known as croup, is one of the common respiratory complaints among children and the most common cause of airway obstruction in children aged six months to six years.
- Trial name
- NCT00938353
- Testing
- beclomethasone dipropionate suspension for nebulisation 800 mcg/2 ml
- Where
- Italy
- Volunteers
- 6 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Confirmatory Dose Finding Study of 2 Dosages of CHF 4226 pMDI (Carmoterol) in Patients With COPD
The purpose of this study is to confirm the dose of CHF 4226 (carmoterol) that should be given once a day to patients with COPD in order for the effect to last for 24 hours.
- Trial name
- NCT00640484
- Testing
- carmoterol (CHF 4226), salmeterol
- Where
- 15 sites in United States
- Volunteers
- 57 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Chronic Obstructive Pulmonary Disease
Evaluation of Possible Effects on the QTc Interval of CHF 4226 pMDI in Healthy Volunteers
The purpose of this study is to evaluate the effect of single doses of therapeutic and supratherapeutic doses of inhaled CHF 4226 pMDI on ventricular repolarization in healthy subjects compared with placebo.
- Trial name
- CT14 (NCT00777595)
- Testing
- CHF 4226 pMDI, Moxifloxacin
- Where
- United States
- Volunteers
- 47 people, healthy volunteers welcome
- Sponsor
- Chiesi Farmaceutici S.p.A.