Drugs / Arformoterol

Regulatory milestones approvals, filings & regulatory actions · 2 recorded

MilestoneJurisdictionBrandIndicationDateSentence it was read from
Label expansion US (FDA) BROVANA 2014-02-27 fda.gov
Approved US (FDA) BROVANA 2006-10-06 fda.gov

Trials 17 · a red edge is where a trial was stopped

PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 24 trials
Phase 2 NCT05055414 Nov 2021 → Oct 2022 COVID-19 Korea United Pharm. Inc. Unknown No outcome recorded
Phase 2 NCT00583947 Jan → Dec 2008 asthma Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 2 NCT00685529 Apr → Oct 2005 chronic obstructive pulmonary disease Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 2 NCT00691405 Oct 2003 → May 2004 chronic obstructive pulmonary disease Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 36 trials
Phase 3 NCT00909779 Jun 2009 → Jun 2012 chronic obstructive pulmonary disease Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 3 NCT00662779 Apr 2008 → Mar 2009 exercise-induced bronchoconstriction University of New Mexico Withdrawn No outcome recorded
Phase 3 NCT00250679 Oct 2005 → Oct 2007 bronchitis, pulmonary emphysema Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 3 NCT00064415 Jun 2002 → Dec 2004 chronic bronchitis, pulmonary emphysema Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 3 NCT00064402 Apr 2002 → Mar 2004 chronic bronchitis, pulmonary emphysema Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 3 NCT00685841 Feb 2002 → Jun 2003 chronic obstructive pulmonary disease Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase 46 trials
Phase 4 NCT03219866 Oct 2017 → Apr 2020 chronic obstructive pulmonary disease Wake Forest University Health Sciences Terminated No outcome recorded
Phase 4 NCT02275481 Nov 2014 → Sep 2016 chronic obstructive pulmonary disease Sumitomo Pharma America, Inc. Terminated No outcome recorded
Phase 4 NCT01361984 Jun 2011 → Jun 2013 chronic bronchitis, pulmonary emphysema University of California, Los Angeles Unknown No outcome recorded
Phase 4 NCT00819637 Jan → Nov 2009 acute asthma Henry Ford Health System Terminated No outcome recorded
Phase 4 NCT00773786 Oct 2008 → May 2009 chronic obstructive pulmonary disease Trinity Health Of New England Completed No outcome recorded
Phase 4 NCT00571428 Nov 2007 → Mar 2008 chronic obstructive pulmonary disease Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase not applicable1 trial
NCT01391559 Jul 2011 → Oct 2012 chronic obstructive pulmonary disease Dartmouth-Hitchcock Medical Center Completed No outcome recorded
Also used as a comparator or background therapy in 3 trials
PhaseRegistry idDatesIndicationSponsorStatusOutcome
Phase 42 trials
Phase 4 NCT00754546 Comparator Aug 2008 → May 2009 chronic obstructive pulmonary disease Dartmouth-Hitchcock Medical Center Completed No outcome recorded
Phase 4 NCT00424528 Comparator Dec 2006 → Oct 2007 bronchitis, pulmonary emphysema Sumitomo Pharma America, Inc. Completed No outcome recorded
Phase not applicable1 trial
NCT00846287 Comparator Nov 2008 → Apr 2011 chronic obstructive pulmonary disease University of Massachusetts, Worcester Completed No outcome recorded

Evidence & citations 12 cited values

Every value below carries the sentence it was read from. 22 sources stand behind the page.

FieldValueCited text
Known as arformoterol “Budesonide/Arformoterol dry powder inhaler, 3 inhalations b.i.d at 3 days and 2 inhalations b.i.d at 11 days” NCT05055414
18

“Subjects will receive the drug arformoterol prior to scanning” NCT00846287

NCT00064415

NCT00819637

NCT02275481

NCT00909779

NCT00685529

NCT00685841

NCT00571428

NCT00583947

NCT00662779

NCT00250679

NCT00064402

NCT01391559

NCT00424528

NCT00754546

NCT00691405

NCT01361984

NCT00773786

Known as ARFORMOTEROL FUMARATE ChEMBL registry synonym — accepted as the source's own label CHEMBL1363
Known as Arformoterol tartrate Arformoterol tartrate inhalation solution 15 mcg (BROVANA) will be administered BID (morning and evening, approximately 12 hours between doses) using a standard jet nebulizer...” NCT02275481
6

Arformoterol tartrate 15 µg/2ml (Brovana) nebulized via PARI-LC Plus® nebulizer with a mouthpiece, connected to a PRONEB® Ultra compressor.” NCT01361984

Arformoterol tartrate (arformoterol, 15 μg bid) is a nebulized long-acting β2-agonist approved for maintenance treatment of COPD.” PMID 25451347 Dec 2014

Arformoterol tartrate inhalation solution 15 mcg twice daily and placebo inhalation powder once daily.” NCT00424528

Arformoterol Tartrate Inhalation Solution” NCT00571428

Arformoterol tartrate inhalation solution” NCT00691405

Arformoterol tartrate inhalation solution” NCT00250679

Known as Brovana “Arformoterol (Brovana)” NCT00773786
1

NCT03219866

Known as Brovana, (R,R)-formoterol Brovana, (R,R)-formoterolNCT00685529
Known as Formoterol r,r-form ChEMBL registry synonym — accepted as the source's own label CHEMBL1363
Known as Formoterol r,r-form l-tartrate ChEMBL registry synonym — accepted as the source's own label CHEMBL1363
Known as RR formoterol “arformoterol (RR formoterol)” NCT00819637
Action Activate “Beta-2 adrenergic receptor agonist” CHEMBL1363
Modality Small molecule CHEMBL1363
Route Inhaled “arformoterol tartrate inhalation solution” NCT00064402
Target ADRB2 “Beta-2 adrenergic receptor agonist” CHEMBL1363