Alvesco (ciclesonide) / Covis Pharma, AstraZeneca, Teijin, Korea University Medical Center - LARVOL DELTA

Inhaled Ciclesonide Study in Preterm Infants (clinicaltrials.gov) - P1 | N=30 | Not yet recruiting | Sponsor: Children's Mercy Hospital Kansas City

New P1 trial • Bronchopulmonary Dysplasia • Pulmonary Disease • Respiratory Diseases

Effective Treatment of COVID-19 Infection with Repurposed Drugs: Case Reports. (PubMed, Viral Immunol) - "Successful administration of multidrug therapy, such as combinations of hydroxychloroquine and azithromycin, doxycycline and ivermectin, or ivermectin, doxycycline, and azithromycin, has been reported. Multidrug therapy is effective because of the differing mechanisms of action of these drugs, and it may also mitigate the emergence of drug-resistant SARS-CoV-2 strains. The medicines were lopinavir/ritonavir (Kaletra), bamlanivimab (monoclonal antibody), glycopyrrolate-formoterol (Bevespi), ciclesonide (Alvesco), famotidine (Pepcid), and diphenhydramine (Benadryl)."

Journal • Cardiovascular • Hematological Disorders • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Thrombosis

PROTECT-V: PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V (clinicaltrials.gov) - P2/3 | N=5000 | Recruiting | Sponsor: Cambridge University Hospitals NHS Foundation Trust | Trial primary completion date: Jul 2023 ➔ Jul 2024

Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

"T3/4 3D images- rocking motion consistent w/ dehiscence @lpbadano @denisamuraru @VLSorrellImages @pattypellikka @marcelohaertel @david_le_bihan @barrettorbm @KemalogluOz @DavidWienerMD @GoncalvesCortez @fljsoares @marciomp50 @RodrigogpLima @masiqueirajr #CardioTwitter" (@AntonioBarros_)

"1/4 Ostium secundum ASD & AS aneurysm -2D #CardioTwitter #MedTwitter #MedEd #echofirst @iamritu @VLSorrellImages @JGrapsa @VDelgadoGarcia @pattypellikka @echo_stepbystep @DavidWienerMD @NMerke @KemalogluOz @alexsfelixecho @GoncalvesCortez @RODRIGOVISCONT1 @fljsoares @echotalk" (@AntonioBarros_)

Cardiovascular

"@ArmandoOterino @ovidiogarciav @pomyers @ThibautPommier @JohnFTrujilloMD @DrSept @CarlosE07799681 @LaleTokgozoglu @ittaniaofficial @t_rosseel @DuWayne_Willett @AleAvalosOddi @Gui_alvescorrea @GiuseppeAnguil1 @ValentinaNardo3 @Venezianofa @benoitl1977 @CardioBornan @Anoncardio" (@SABOURETCardio)

"@DCHFT_Research @abdul_alkindy @JorCandela @asemeve @ajtochterman @Gui_alvescorrea @MauroEchavPinto @FernanOCT @MarLombard1 @jhollowedmd @StellaMMacin @juliomayol @IIS_IdISSC @cathlabnewbie @davidmasheka1 @javierlopezpais @jbbhalke" (@InocaInternati1)

"@DCHFT_Research @abdul_alkindy @JorCandela @asemeve @ajtochterman @Gui_alvescorrea @MauroEchavPinto @FernanOCT @MarLombard1 @jhollowedmd @StellaMMacin @juliomayol @IIS_IdISSC @cathlabnewbie @davidmasheka1 @javierlopezpais @jbbhalke" (@InocaInternati1)

"Daar heb ik Alvesco voor. Voor het slapen 1x inhaleren. Als ik ziek ben 2x2. En impratropium voor tussendoor." (@dextertjekater1)

"@DCHFT_Research @abdul_alkindy @JorCandela @asemeve @ajtochterman @Gui_alvescorrea @MauroEchavPinto @FernanOCT @MarLombard1 @jhollowedmd @StellaMMacin @juliomayol @IIS_IdISSC @cathlabnewbie @davidmasheka1 @javierlopezpais @jbbhalke" (@InocaInternati1)

"@DCHFT_Research @abdul_alkindy @StefanoNistri @JorCandela @asemeve @ajtochterman @Gui_alvescorrea @MauroEchavPinto @FernanOCT @coroventis @NunezPernas @MarLombard1 @jhollowedmd @StellaMMacin @juliomayol @IIS_IdISSC @cathlabnewbie @davidmasheka1 @javierlopezpais @jbbhalke" (@InocaInternati1)

Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma (clinicaltrials.gov) - P4 | N=110 | Recruiting | Sponsor: Hvidovre University Hospital | Not yet recruiting ➔ Recruiting | Trial completion date: Jan 2024 ➔ Jun 2024 | Trial primary completion date: Jan 2024 ➔ Jun 2024

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

"⚠️ CEUS for cardiac masses ✅ Metastatic Neuroendocrine tumor #echofirst #cardiotwitter @CardioOncCOIN @CCardiacON @ICOSociety @fazalabul @FabianKnebel @KardiologieHH @echoguru @GoncalvesCortez @wikimagen @Hragy @HeartOTXHeartMD @VerwerftJan @VLSorrellImages" (@alexsfelixecho)

Endocrine Cancer • Neuroendocrine Tumor • Oncology • Solid Tumor

PROTECT-V: PROphylaxis for paTiEnts at Risk of COVID-19 infecTion -V (clinicaltrials.gov) - P2/3 | N=5000 | Recruiting | Sponsor: Cambridge University Hospitals NHS Foundation Trust | N=1500 ➔ 5000 | Trial completion date: Mar 2022 ➔ Oct 2024 | Trial primary completion date: Dec 2021 ➔ Jul 2023

Enrollment change • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease

COVERAGE: Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation (clinicaltrials.gov) - P2/3 | N=412 | Completed | Sponsor: University Hospital, Bordeaux | Recruiting ➔ Completed | N=820 ➔ 412 | Trial completion date: Feb 2022 ➔ Oct 2021 | Trial primary completion date: Jan 2022 ➔ Oct 2021

Enrollment change • Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Tumor • CD4

Inhalation of Ciclesonide for Patients With COVID-19: A Randomised Open Treatment Study (HALT COVID-19) (clinicaltrials.gov) - P2 | N=98 | Active, not recruiting | Sponsor: Ola Blennow, MD, PhD | Recruiting ➔ Active, not recruiting | N=446 ➔ 98 | Trial completion date: May 2022 ➔ Jan 2022 | Trial primary completion date: Dec 2021 ➔ Aug 2021

Enrollment change • Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Pneumonia • Respiratory Diseases

"@MarcosPauloLa11 @GE_IanMc @jpcostabel @RobertoC8a @DrLustosa @GoncalvesCortez @alessia_gimelli @mmamas1973 @pabeda1 @escardio @ASE360 @papathanasiou_ @MattersoftheH14 @The_echo_lady @rajdoc2005 @DrRajeshG1 @DocMathias @marcelohaertel @SABOURETCardio @3DEcho_Brazil @echotalk" (@alexsfelixecho)

Assessment of the effectiveness of early treatment in SARS-CoV-2 infection (PubMed, Pol Merkur Lekarski) - "The effectiveness of azithromycin, arechin, methylprednisolone and ciclesonide in controlling inflammation caused by SARSCoV- 2 infection has been confirmed in treated patients with symptoms of COVID-19 on an outpatient basis. The use of the assessed drugs should take into account the time of onset of SARS-CoV-2 infection and the severity of the disease course, including comorbidities. The presented analysis of the effectiveness of early treatment in patients infected with SARS-CoV-2 requires further clinical trials."

Journal • Immunology • Infectious Disease • Inflammation • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases

"@MattersoftheH14 @Echo_DGK_GER @thevalveclub @SABOURETCardio @VLSorrellImages @pabeda1 @escardio @GoncalvesCortez @argulian @RobertoC8a @robertomlang @mirvatalasnag @barrettorbm @kaschenke @MarrugoErick @ErinMichos @EricTopol @meucci_chiara @CuitlhuacArroy1 @CyntiaMachain" (@alexsfelixecho)

Periostin-guided Withdrawal of Inhaled Corticosteroids in Patients With Non-eosinophilic Asthma (clinicaltrials.gov) - P4; N=110; Not yet recruiting; Sponsor: Hvidovre University Hospital; Phase classification: P=N/A ➔ P4; Trial primary completion date: Jun 2023 ➔ Jan 2024

Clinical • Phase classification • Trial primary completion date • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases • POSTN

"@TakedaPharma, skontrolujcie w laboratorium, czy #Alvesco, które kupiłam w aptece (zdjęcia), wyprodukowała #Zentiva w Polsce? Alvesco Zentivy, to inny "lek", niż Alvesco #Takeda - ma nie wymieniony składnik, który zaraża covid'em, żeby ciclesonidum likwidował covid. @AstraZeneca" (@KTrzcinska)

Novel Coronavirus Disease

For which drugs the NHF paid the most in 2020 (Termedia) - "Fostair (100 mcg + 6 mcg) / dose, volume 180 doses - 98 703 891.91 PLN. Combined medicine for the treatment of asthma (inhaled corticosteroid and long-acting β 2 agonist). Throughout 2020, 605.8 thousand zlotys were spent in pharmacies. packaging. Patients paid more than PLN 11 million. Alvesco 160, 160 mcg / dose inh., Capacity 120 doses - 79 105 502.14 PLN. An inhaled corticosteroid for use in the regular long-term treatment of asthma. Almost 584.5 thousand were spent in pharmacies. packaging, patients paid an additional PLN 6.352 million, the NHF expense amounted to almost PLN 80 million."

Reimbursement • Asthma • Respiratory Diseases

Inhaled Ciclesonide for Outpatients With COVID19 (clinicaltrials.gov) - P2/3; N=215; Terminated; Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre; Active, not recruiting ➔ Terminated; could not meet target enrolment

Clinical • Trial termination • Infectious Disease • Novel Coronavirus Disease

COVERAGE: Trial of COVID-19 Outpatient Treatment in Individuals With Risk Factors for Aggravation (clinicaltrials.gov) - P2/3; N=820; Recruiting; Sponsor: University Hospital, Bordeaux; Trial completion date: Aug 2021 ➔ Feb 2022; Trial primary completion date: Aug 2021 ➔ Jan 2022

Clinical • Trial completion date • Trial primary completion date • Infectious Disease • Novel Coronavirus Disease • Respiratory Diseases • Solid Tumor • CD4

A simple and rapid method to simultaneously analyze ciclesonide and its impurities in a ciclesonide metered-dose inhaler using on-line supercritical fluid extraction/supercritical fluid chromatography/quadrupole time-of-flight mass spectrometry. (PubMed, J Pharm Biomed Anal) - "CIC-MDI, as drug Alvesco®, has been approved for the treatment of bronchial asthma, and its major impurities are listed in the European Pharmacopoeia and in the supplementary package inserts of Alvesco® (called as "Pharmaceutical interview form" in Japan)...In the SFE, CIC and its impurities and other impurities having various polarities and hydrophobicity, were extracted in 3.5 min and subsequently separated on a CHIRALPAK IE-3 column to be detected by quadrupole TOF-MS in 6.5 min. This method would be applicable to the analysis of other inhalable pharmaceutical products whose sample preparation requires complicated procedures, as well as to the analysis of general pharmaceutical products for profiling impurities."

Journal • Asthma • Immunology • Pulmonary Disease • Respiratory Diseases