Clinical trials: Severe Persistent Asthma
Bronchial Asthma
Efficacy and Tolerability of Beclomethasone Dipropionate 100 µg + Formoterol 6 µg pMDI Via HFA-134a Vs. Budesonide 160 µg + Formoterol 4,5 µg Dry Powder Via Turbuhaler®. (Symbicort®)
The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of budesonide/formoterol dry powder via Turbuhaler.
- Trial name
- NCT00413387
- Testing
- beclomethasone dipropionate plus formoterol fumarate combination, budesonide plus formoterol combination
- Where
- 13 sites in Austria, Poland and 1 more
- Volunteers
- 219 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
Masitinib in the Treatment of Patients With Severe Uncontrolled Asthma and Elevated Eosinophil Levels
The purpose of this study is to assess the safety and efficacy of masitinib (6 mg/kg/day) in severe persistent asthma, uncontrolled with high dose of inhaled corticosteroid and with elevated eosinophil levels.
- Trial name
- NCT03771040
- Testing
- Masitinib
- Where
- 5 sites in Argentina, Malaysia and 3 more
- Volunteers
- 347 people
- Sponsor
- AB Science
Asthma
Efficacy and Safety of Omalizumab in Patients With Severe Persistent Asthma
The purpose of this study is to determine the effect of omalizumab, compared to placebo, on clinically significant asthma exacerbation rates in adolescents and adults with asthma.
- Trial name
- NCT00046748
- Testing
- Omalizumab
- Volunteers
- 484 people
- Sponsor
- Novartis Pharmaceuticals
Asthma
Study to Evaluate the Safety and Efficacy of CAT-354
This is a Phase 2a, randomized, double-blind, placebo-controlled, parallel-arm study to evaluate the efficacy and safety of 3 subcutaneous (SC) treatment regimens of CAT-354 in adult subjects with uncontrolled…
- Trial name
- NCT00873860
- Testing
- CAT-354 150 mg, CAT-354 300 mg, CAT-354 600 mg
- Where
- 57 sites in Bulgaria, Germany and 3 more
- Volunteers
- 357 people
- Sponsor
- MedImmune LLC
Asthma
An Efficacy and Safety Evaluation of Tiotropium add-on Therapy in Patients With Severe Persistent Asthma
The primary objective of this study is to examine efficacy and safety of tiotropium compared to plac ebo as add-on therapy in severe asthmatics according to GINA step 4 classification
- Trial name
- NCT00365560
- Testing
- tiotropium
- Where
- 16 sites in Denmark, Germany and 1 more
- Volunteers
- 115 people
- Sponsor
- Boehringer Ingelheim
Bronchial Asthma
EFFICACY AND TOLERABILITY OF BECLOMETHASONE DIPROPIONATE 100 µg + FORMOTEROL 6 µg pMDI VIA HFA-134a vs. FLUTICASONE 125 µg + SALMETEROL 25 µg pMDI
The aim of this study was to compare the efficacy and tolerability of the fixed combination beclomethasone/formoterol pMDI with that of fluticasone/salmeterol pMDI in patients with moderate to severe asthma
- Trial name
- NCT00394368
- Testing
- beclomethasone dipropionate plus formoterol fumarate combination, fluticasone propionate plus salmeterol xinafoate combination
- Where
- 12 sites in Poland, Ukraine
- Volunteers
- 180 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
A Study of the Effectiveness and Safety of Different Doses of Fluticasone Propionate Taken From a Dry Powder Inhaler (Puffer) in Adolescents and Adults Who Have Asthma That is Not Controlled by High Dose Inhaled Corticosteroid Asthma Medications
The primary objective of this study is to evaluate the dose response, efficacy and safety of 4 different doses of fluticasone propionate (50, 100, 200, and 400mcg) delivered as Fluticasone Spiromax® Inhalation Powder (Fp…
- Trial name
- NCT01576718
- Testing
- Fp MDPI, Flovent Diskus, albuterol/salbutamol
- Where
- 300 sites in United States, Australia and 17 more
- Volunteers
- 889 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D, Inc.
Moderate to Severe Persistent Asthma
Efficacy and Safety of CBP-201 in Patients With Moderate to Severe Persistent Asthma With Type 2 Inflammation
This study will evaluate the efficacy, safety of two dose levels of CBP-201 in patients with moderate to severe persistent asthma with Type 2 inflammation.
- Trial name
- NCT04773678
- Testing
- CBP-201
- Where
- 76 sites in United States, China and 3 more
- Volunteers
- 322 people
- Sponsor
- Connect Biopharm LLC
Asthma
A Study to Evaluate the Safety of Xolair in Moderate to Severe Persistent Asthma Patients (ALTO)
This was a multicenter, open label, randomized, controlled, safety trial in subjects aged 6-75 years with a diagnosis of moderate to severe, persistent asthma.
- Trial name
- NCT00401596
- Testing
- Xolair (omalizumab)
- Volunteers
- 1,899 people
- Sponsor
- Genentech, Inc.
Asthma
Omalizumab in Adult and Adolescent Patients With Severe Persistent Allergic Asthma
Omalizumab will be given as add-on treatment to optimized asthma therapy in patients with severe persistent asthma, who demonstrate inadequate asthma symptom control.
- Trial name
- NCT00264849
- Testing
- Omalizumab, Optimized asthma therapy
- Where
- 17 sites in Belgium, Canada and 15 more
- Volunteers
- 406 people
- Sponsor
- Novartis
Asthma
Cross-over Study to Evaluate the Effect on Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks Treatment With CHF 5188 pMDI qd in Adult Patients With Persistent Asthma
Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma
- Trial name
- NCT01070524
- Testing
- CHF 5188 pMDI, Budesonide extrafine pMDI, Seretide(r) Evohaler(r)
- Where
- United Kingdom
- Volunteers
- 113 people
- Sponsor
- Chiesi Farmaceutici S.p.A.
Asthma
A Study of Omalizumab (Xolair) in Subjects With Moderate to Severe Persistent Asthma (EXTRA)
This is a multicenter, randomized, double-blind, placebo-controlled study of the efficacy, safety, and tolerability of subcutaneously administered Xolair as add-on therapy for the treatment of subjects aged 12-75 years old…
- Trial name
- NCT00314574
- Testing
- omalizumab (Xolair), corticosteroids, long-acting beta-agonists
- Volunteers
- 850 people
- Sponsor
- Genentech, Inc.
Asthma
Successful Control and Clinical Effectiveness Of SERETIDE(Salmeterol/Fluticasone Propionate) Study In Asthma.(SUCCESS)
The primary study objective is to demonstrate the clinical effectiveness of SERETIDE therapy compared to the current care in management of moderate to severe persistent asthma patients in Korea.
- Trial name
- NCT00480649
- Testing
- Salmeterol/ fluticasone propionate
- Where
- 12 sites in South Korea
- Volunteers
- 424 people
- Sponsor
- GlaxoSmithKline
Asthma
Evaluation of Tiotropium 2.5 and 5 µg Once Daily Delivered Via the Respimat Inhaler Compared to Placebo in Patient With Moderate to Severe Persistent Asthma
The aim of this trial is to evaluate the safety and efficacy of 2.5 and 5 µg tiotropium over a 52-week treatment period as compared to placebo.
- Trial name
- NCT01340209
- Testing
- Tiotropium Respimat
- Where
- 55 sites in Japan
- Volunteers
- 285 people
- Sponsor
- Boehringer Ingelheim
Asthma
A Study of Safety and Efficacy of CNTO 148 in Patients With Severe Persistent Asthma
The purpose of this study is to evaluate the effectiveness and safety of CNTO 148 (golimumab) in patients with severe persistent asthma.
- Trial name
- NCT00207740
- Testing
- CNTO148
- Where
- 57 sites in United States, Belgium and 9 more
- Volunteers
- 309 people
- Sponsor
- Centocor, Inc.
Asthma
Efficacy, Safety, and Tolerability of Dupilumab in Patients With Persistent Moderate to Severe Eosinophilic Asthma
Primary Objective: To investigate the effects of Dupilumab (SAR231893/REGN668) administered subcutaneously (SC) once weekly (qw) for 12 weeks as compared to placebo on reducing the incidence of asthma exacerbation in participants…
- Trial name
- NCT01312961
- Testing
- Dupilumab, Fluticasone/Salmeterol combination therapy, Fluticasone monotherapy
- Where
- 50 sites in United States
- Volunteers
- 104 people
- Sponsor
- Sanofi
Severe Asthma
Bronchial Thermoplasty in Severe Persistent Asthma
As Conditions of Approval of the PMA for the Alair System, the FDA requires Boston Scientific to generate data to assess the durability of the BT treatment effect as well as safety data in the intended use population in the…
- Trial name
- PAS2 (NCT01350336)
- Testing
- Alair System
- Where
- 27 sites in United States, Canada
- Volunteers
- 284 people
- Sponsor
- Boston Scientific Corporation
Asthma
Efficacy of Ciclesonide and Fluticasone Propionate in Adult Patients With Moderate and Severe Persistent Asthma (18 to 75 y) (BY9010/IT-101)
The aim of the study is to compare the safety and efficacy of ciclesonide versus fluticasone propionate on the lung function, symptoms, use of rescue medication, and occurrence of side effects (such as candidiasis, hoarseness) in…
- Trial name
- NCT00163319
- Testing
- Ciclesonide
- Where
- 89 sites in Belgium, France and 5 more
- Volunteers
- 500 people
- Sponsor
- AstraZeneca
Asthma
Efficacy and Safety Study of Fluticasone Proponate Inhalation Solution in Adult and Adolescent Asthma
This is a multicentre, randomized, single-blind, active-controlled, parallel-group phase III local registration study for a treatment period of 12 weeks.
- Trial name
- NCT01687283
- Testing
- fluticasone propionate inhalation solution, budesonide suspension
- Where
- 25 sites in China
- Volunteers
- 316 people
- Sponsor
- GlaxoSmithKline
Asthma
Specific Use-result Surveillance of Spiriva Respimat in Asthmatics
The safety of Spiriva® 2.5 µg Respimat® 60 puffs (hereinafter referred to as Spiriva® Respimat®) in patients with severe persistent asthma under the real-world use was not confirmed in clinical trials.
- Trial name
- NCT02489981
- Testing
- Spiriva
- Where
- Brazil
- Volunteers
- 359 people
- Sponsor
- Boehringer Ingelheim