Alenia (budesonide/formoterol) / Ache Lab - LARVOL DELTA

ESPIRE: A Multicenter, Randomized, Parallel, Two-period, Non-inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment (clinicaltrials.gov) - P3 | N=472 | Completed | Sponsor: Eurofarma Laboratorios S.A. | Recruiting ➔ Completed | Trial completion date: Nov 2025 ➔ Oct 2024 | Trial primary completion date: Mar 2025 ➔ Oct 2024

Head-to-Head • Trial completion • Trial completion date • Trial primary completion date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

ESPIRE: A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment (clinicaltrials.gov) - P3 | N=472 | Recruiting | Sponsor: Eurofarma Laboratorios S.A. | Trial completion date: Jul 2025 ➔ Nov 2025 | Trial primary completion date: Sep 2024 ➔ Mar 2025

Head-to-Head • Trial completion date • Trial primary completion date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

FORASMA: Non-Inferiority,Combination Formoterol/FluticasonexAlenia®Formoterol/Budesonide for Asthma in Brazil (clinicaltrials.gov) - P3 | N=132 | Not yet recruiting | Sponsor: Eurofarma Laboratorios S.A. | Trial completion date: Feb 2026 ➔ Jul 2026 | Trial primary completion date: Jun 2025 ➔ May 2026

Head-to-Head • Trial completion date • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases

ESPIRE: A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment (clinicaltrials.gov) - P3 | N=472 | Recruiting | Sponsor: Eurofarma Laboratorios S.A. | Not yet recruiting ➔ Recruiting | Trial completion date: Dec 2025 ➔ Jul 2025 | Trial primary completion date: Jun 2025 ➔ Sep 2024

Enrollment open • Trial completion date • Trial primary completion date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment (clinicaltrials.gov) - P3 | N=472 | Not yet recruiting | Sponsor: Eurofarma Laboratorios S.A. | Trial completion date: Dec 2024 ➔ Dec 2025 | Trial primary completion date: Jan 2023 ➔ Jun 2025

Head-to-Head • Trial completion date • Trial primary completion date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

"Eutelsat Selects Thales Alenia Space to Build a New Flexible Software-Defined Satellite https://t.co/fTm8cGwewb" (@NewsFromBW)

Pharmacovigilance in Brazil: safety of budesonide-formoterol (ERS 2022) - "Considering this analysis, we can conclude that the use of a wide-spread molecule, such as budesonide-formoterol combination in Brazil, was associated with a few occurrence of adverse events and, when reported, were mostly non-serious events."

Adverse events • Clinical • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

A Multicenter, Randomized, Parallel, Two-Period, Non-Inferiority Study of EurofarmavsAlenia in Asthma and COPD Treatment (clinicaltrials.gov) - P3 | N=472 | Not yet recruiting | Sponsor: Eurofarma Laboratorios S.A. | Trial completion date: Dec 2022 ➔ Dec 2024 | Trial primary completion date: Jul 2022 ➔ Jan 2023

Head-to-Head • Trial completion date • Trial primary completion date • Asthma • Chronic Obstructive Pulmonary Disease • Immunology • Pulmonary Disease • Respiratory Diseases

"New-generation Satellite EUTELSAT KONNECT VHTS Built by Thales Alenia Space Heading to Kourou Launch Site https://t.co/3GbfGtvA9z" (@NewsFromBW)

[VIRTUAL] USE OF ERYTHROPOETIN IN AUTOIMMUNE HEMOLYTIC ANEMIA: A CASE REPORT (HEMO 2021) - "Introduction Autoimmune hemolytic anemia (AIHA) is a disorder caused by autoantibodies directed against erythrocytes of the self. Diagnosis is made through laboratory tests and clinical evidence of hemolysis. However, it is a clinically heterogeneous disease in clinical and therapeutic terms, which makes its treatment difficult. Case report ASA, female, 74 years old, with a history of systemic arterial hypertension, hypothyroidism, asthma and obesity, using simvastatin, levothyroxine , losartan, hydrochlorthiazide and alenia. Hospitalization history in 2017 for AHAI using corticosteroids and cyclophosphamide. He was hospitalized for severe, symptomatic anemia with progressive dyspnea for five months without bleeding episodes. Laboratory tests showed a hemoglobin concentration of 4.1 g/L and reticulocytopenia of 4,400 mm3/L. The direct Coombs test was positive, immunoglobulin G eluate was reactive in all cells and cryoagglutinins were..."

Clinical • Anemia • Asthma • Endocrine Disorders • Genetic Disorders • Hematological Disorders • Hepatology • Hypertension • Immunology • Liver Failure • Obesity • Pulmonary Arterial Hypertension • Pulmonary Disease • Respiratory Diseases

A Real-life Experience on Treatment of Patients With COVID 19 (clinicaltrials.gov) - P2/3; N=120; Recruiting; Sponsor: Tanta University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

The Efficacy of Ivermectin and Nitazoxanide in COVID-19 Treatment (clinicaltrials.gov) - P2/3; N=300; Recruiting; Sponsor: Tanta University; N=60 ➔ 300

Clinical • Enrollment change • Infectious Disease • Novel Coronavirus Disease

The Efficacy of Ivermectin and Nitazoxanide in COVID-19 Treatment (clinicaltrials.gov) - P2/3; N=60; Recruiting; Sponsor: Tanta University; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Infectious Disease • Novel Coronavirus Disease

Budesonide and formoterol reduce early innate anti-viral immune responses in vitro (PLoS One) - Combination of budesonide and formoterol also inhibited RV16-stimulated expression of the type I IFN induced genes myxovirus protein A and 2,5' oligoadenylate synthetise; In RV16 stimulated PBMC, the combination of budesonide and formoterol inhibited IFNα and IP-10 production in asthmatic as well as healthy donors

In vitro study • Asthma

Utilization of fixed combination (budesonide/formoterol and salmeterol/fluticasone and beclomethasone/formoterol) in treatment of asthma patients (UFO) (clinicaltrials.gov) - P=Obs, N=2,815; N=3000→2815; Recruiting→Completed

Enrollment • Enrollment closed • Trial completion • Asthma

Early efficacy of budesonide/formoterol in patients with moderate-to-very-severe COPD (Dovepress) - P=NA, N=1,571; "Treatment with B/F decreased exacerbations in patients with moderate-to-very-severe COPD within 3 months of commencing treatment. This effect was paralleled by improved lung function, less reliever medication use, and fewer symptoms, irrespective of disease severity."

Clinical data • Chronic Obstructive Pulmonary Disease

Nitazoxanide Plus Lactulose Versus Lactulose Alone Treatment of Hepatic Encephalopathy (clinicaltrials.gov) - P2/3; N=120; Recruiting; Sponsor: Sherief Abd-Elsalam; Trial primary completion date: Dec 2015 ➔ Dec 2016

Trial primary completion date • Biosimilar

A Real-life Experience on Treatment of Patients With COVID 19 (clinicaltrials.gov) - P2/3; N=100; Not yet recruiting; Sponsor: Tanta University

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease

The Efficacy of Ivermectin and Nitazoxanide in COVID-19 Treatment (clinicaltrials.gov) - P2/3; N=60; Not yet recruiting; Sponsor: Tanta University

Clinical • New P2/3 trial • Infectious Disease • Novel Coronavirus Disease

"Global High-Altitude Platform Station Systems - Google, Facebook, Airbus & Thales Alenia Space - https://t.co/guyiBzPH8C https://t.co/qwmbErmJgs" (@NewsFromBW)

Clinical

A Multicenter, Randomized, Parallel, Open, Two-period, Comparative Non-inferiority Clinical Trial of Eurofarma Versus Alenia® in the Treatment of Moderate to Severe (clinicaltrials.gov) - P3; N=472; Not yet recruiting; Sponsor: Eurofarma Laboratorios S.A.

Clinical • Head-to-Head • New P3 trial