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Data updated: May 26, 2026

AIRDUO DIGIHALER (fluticasone propionate)

Respiratory Approved 2017-01-27
Jump to: Indications Approvals Trials Competitors Safety Patents
2
Indications
--
Phase 3 Trials
9
Years on Market

Details

Status
Discontinued
First Approved
2017-01-27
Patent Cliff
2041

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Routes
INHALATION
Dosage Forms
POWDER

Companies

Teva
Active Ingredient: FLUTICASONE PROPIONATE , SALMETEROL XINAFOATE

AIRDUO DIGIHALER Approval History

2018
2019
2020
2021
2022
2023
2024
2025
2026
Original
New Indication
New Form
Label Update
21 FDA actions from 2017 to 2023 · 1 indication expansions
Nov 2023 SUPPL
Label · Labeling
FDA Letter Label
Jan 2022 SUPPL
Label · Labeling
FDA Letter Label
Jul 2021 SUPPL
Efficacy
FDA Letter Label

What AIRDUO DIGIHALER Treats

2 FDA approvals

Originally approved for its first indication in 2017 . Covers 2 distinct patient populations.

  • Other (2)
📋

Clinical Trial Registry

58 trials
Trial Sponsor ID Phase Status Title
NCT02476825 168769 Ph 4 active not recruiting A Bronchoscopy Study to Assess the Effects of Inhaled Corticosteroids on Adult Healthy Volunteers
NCT05535738 STUDY00000321 Ph 2, Ph 3 active not recruiting Using a Contact Dermatitis Model With Biologic Medications to Study Skin Inflammation
NCT01396278 results posted 1248.7 2010-023169-23 Ph 2 terminated Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Medium Dose Inhaled Corticosteroid (ICS).
NCT03040596 STUDY19040139 Ph 1 terminated The Effect of Inhaled Corticosteroids on Vocal Fold Nodules in Children
NCT05444543 results posted STUDY20210671 Ph 4 completed Cycling of Topical Steroids for Treatment of EoE (Eosinopilic Esophagitis)
NCT02402465 results posted IRB14-1199 Ph 4 completed Factors Involved in Dymista's Superior Clinical Efficacy in the Treatment of Seasonal Allergic Rhinitis
NCT03199976 results posted TFS01 2015-002985-22 Ph 4 terminated Efficacy of Intermittent Tiotropium in Early Childhood Wheezing
NCT04601324 Allergic Rhinitis Protocol Ph 4 withdrawn Allergic Rhinitis Combination Pharmacotherapy Efficacy Study
NCT03926026 results posted NCX-4251-01 Ph 2 completed Study Evaluating the Safety and Tolerability of NCX 4251 for the Treatment of Acute Exacerbations of Blepharitis
NCT02246920 results posted 71336007 Ph 3 terminated Clinical Equivalence Study of Fluticasone Propionate Nasal Spray, 50 mcg/Actuation vs. Flonase in Allergic Rhinitis Patients
NCT05314621 21-960-0005 Ph 4 completed A Study Comparing the Efficacy of Pataday® Once Daily Relief Extra Strength to Flonase® Allergy Relief in Subjects With Allergic Conjunctivitis
NCT01397162 results posted 1248.5 2010-023167-17 Ph 2 terminated Dose Finding Study on BI54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat® Inhaler in Asthmatic Patients Inadequately Controlled on Short-acting-beta-agonist (SABA) Therapy
NCT01397201 results posted 1248.6 2010-023168-41 Ph 2 terminated Study on BI 54903 (Inhaled Corticosteroid) Administered Twice Daily Via Respimat Inhaler in Patients With Asthma Inadequately Controlled on Low Dose Inhaled Corticosteroid (ICS)
NCT02232087 results posted DDSD-1030-SAFL Ph 1 completed Single Blind Cross-over Dose Response Study in Subjects of Two Inhalers of Salmeterol and Fluticasone Propionate
NCT01092143 results posted 1268.17 Ph 2 completed BI 671800 ED in Steroid-naive Asthmatic Patients
NCT02980133 results posted FSS-AS-30003 2016-003835-39 Ph 3 completed Study of Fluticasone Propionate Multidose Dry Powder Inhaler Compared With Fluticasone Propionate/Salmeterol Multidose Dry Powder Inhaler
NCT04179461 results posted ARC 7 Ph 2 completed Personalized Treatment Algorithms for Difficult-to-treat Asthma
NCT04242368 IRB-53836 Ph 2, Ph 3 withdrawn Hypertonic Versus Isotonic Saline Irrigations for Chronic Rhinosinusitis
NCT01578278 results posted S00186 Ph 2 completed Bepotastine Besilate-corticosteroid Nasal Spray Combination Compared to Placebo, Bepotastine Besilate Nasal Spray, and Corticosteroid Nasal Spray in the Treatment of Patients With Seasonal Allergic Rhinitis
NCT03591068 results posted OPN-FLU-NP-3104 Ph 3 completed Efficacy & Safety of OPN-375 Adults With Bilateral Nasal Polyps Using Nasoendoscopic Video
NCT03240575 results posted 1237-0063 Ph 4 completed The ENERGITO® 2 Study Compares 2 Inhaled Medicines for Chronic Obstructive Pulmonary Disease (COPD). One Medicine is a Combination of Tiotropium and Olodaterol (Stiolto®) Taken Using the Respimat® Inhaler and the Other Medicine is a Combination of Fluticasone and Salmeterol Taken Using the Diskus
NCT04332978 LB1108 LB1108 Ph 3 completed Topical Nasal Fluticasone Propionate in the Control of Allergic Rhinitis SymptomsPerene
NCT03207243 results posted 207597 2017-001072-34 Ph 2 completed Efficacy and Safety Study of GSK3772847 in Subjects With Moderately Severe Asthma
NCT03112577 R3500-AS-1633 2016-003165-26, SAR440340 Ph 1 completed Study of REGN3500 and Dupilumab in Patients With Asthma
NCT03443843 19880 Ph 4 completed A Study to Evaluate Changes in Nasal Airflow of Loratadine/Pseudoephedrine Tablet and Fluticasone Propionate Nasal Spray in Subjects Following Allergen Exposure
NCT03055988 results posted 1237.36 2015-002641-66 Ph 4 completed Cardiovascular Function in COPD Patients
NCT00995657 PAW003 Ph 4 completed Dose Response of Fractional Exhaled Nitric Oxide (FeNO) to Inhaled Steroids in Mild-to-moderate Asthma
NCT02446418 results posted 116492 Ph 3 completed A Study to Compare the Efficacy of Fluticasone Furoate/Vilanterol Inhalation Powder With Usual Inhaled Corticosteroids (ICS)/Long Acting Beta Agonists (LABA) in Persistent Asthma
NCT01622569 results posted OPN-FLU-NP-3101 Ph 3 completed Study Evaluating the Efficacy and Safety of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi Directional Device in Subjects With Bilateral Nasal Polyposis Followed by an 8-Week Open-Label Extension Phase to Assess Safety
NCT01624662 results posted OPN-FLU-NP-3102 Ph 3 completed Efficacy and Safety Study of Intranasal Administration of 100, 200, and 400 μg of Fluticasone Propionate Using a Novel Bi-directional Device
NCT01915914 results posted 117291 Ph 4 completed A Randomized, Open-label, Comparative Study to Evaluate an Intermittent Dosing Regimen of Fluticasone Propionate 0.05% Cream (Twice Per Week) in Reducing the Risk of Relapse When Added to Regular Daily Moisturization Using PHYSIOGEL Lotion in Paediatric Subjects With Stabilized Atopic Dermatitis
NCT01018186 results posted 106839 Ph 3 completed Fluticasone Furoate/GW642444 Inhalation Powder Long-Term Safety Study
NCT01623310 results posted OPN-FLU-CS-3203 Ph 3 completed 12-Month OL Intranasal Fluticasone Propionate BID Using OptiNose Device
NCT00843193 results posted 106870 Ph 2 completed Efficacy and Safety Study of GSK679586 in Patients With Severe Asthma
NCT01159912 results posted 112059 Ph 3 completed Evaluating the Efficacy and Safety of Fluticasone Furoate Inhalation Powder in the Treatment of Asthma in Adults and Adolescents
NCT01307462 FAM for BOS results posted 2367.00 NCI-2011-00203, U54CA163438 Ph 2 completed Targeted Therapy of Bronchiolitis Obliterans Syndrome
NCT01563029 results posted 106855 Ph 2 completed A Dose-ranging Study of Fluticasone Furoate (FF)
NCT02523820 ID10-57-18 Ph 3 completed Nebulized Corticosteroid for Post Extubation Stridor in Children
NCT00814216 CQAV680A2201 EudraCT number: 2008-005168-15 Ph 2 completed Efficacy, Safety and Pharmacokinetics of QAV680 in Asthma Patients
NCT00612820 IPR110723 Ph 2 completed A Phase II Study Evaluating Intranasal GSK256066 and Fluticasone Propionate in Subjects With Seasonal Allergic Rhinitis (SAR)
NCT01623323 results posted OPN-FLU-CS-3204 Ph 3 completed Study Evaluating the Safety of Intranasal Administration of 400 μg of Fluticasone Propionate Twice a Day (BID) Using a Novel Bi-Directional Device in Subjects With Chronic Sinusitis With or Without Nasal Polyps
NCT02466347 MCPE14014M1 Ph 1 completed Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers Without Charcoal Block
NCT01969721 results posted 1237.11 2013-000808-41 Ph 3 completed Characterization of Lung Function Profile of Inhaled Tiotropium + Olodaterol Fixed Dose Combination Compared to Fluticasone Propionate + Salmeterol Fixed Dose Combination in COPD Patients
NCT00869596 0000-128 2009_565 Ph 1 completed Study of Biomarkers of Airway Inflammation (0000-128)
NCT02466503 MCPE14015M1 Ph 1 completed Bioequivalence Study of Synflutide HFA Inhaler and Seretide Evohaler in Healthy Volunteers With Charcoal Block
NCT00975195 results posted 352.2046 2007-002522-29 Ph 4 completed Inhaled Corticosteroid Withdrawal in Patients With Chronic Obstructive Pulmonary Disease
NCT01516073 191-091 Ph 2 completed 12-Week Study in Adult Subjects With Asthma
NCT01103934 results posted 10-184-B Ph 4 completed Vitamin D Plus Fluticasone Propionate
NCT01817790 results posted RH01619 Ph 3 completed Assessment of Fluticasone Propionate on Ocular Allergy Symptoms
NCT00883168 results posted MP4006 Ph 3 completed A Study to Evaluate the Safety and Effectiveness of a Nasal Spray to Treat Seasonal Allergies

Showing 50 of 58 trials

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Key Completed Trials

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Completed studies with published results, ranked by significance

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Trial Timeline

ClinicalTrials.gov ↗ Pro

Full development history with FDA approval milestones

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Understanding FDA Approval Types
Count Type What it means
- ORIG Original approval - drug first enters market
- SUPPL - Efficacy New indication (new disease/condition approved)
- SUPPL - Labeling Label text changes (warnings, dosing updates)
- SUPPL - Manufacturing Production changes (new facility)
- SUPPL - Chemistry Formulation changes (new dosage strength)

Green lines in the timeline show ORIG and Efficacy approvals - the clinically meaningful milestones.

AIRDUO DIGIHALER FDA Label Details

View full patent landscape →
14 OB patents · 7 families · 341 international docs across 34 countries

AIRDUO DIGIHALER Patents & Exclusivity

Latest Patent: Jan 2041

Patents (14 active)

US11173259*PED Expires Jan 6, 2041
US11173259 Expires Jul 6, 2040
US11344685*PED Expires Mar 26, 2040
US11969544*PED Expires Feb 20, 2040
US11344685 Expires Sep 26, 2039
US11969544 Expires Aug 20, 2039
US10918816*PED Expires Jun 14, 2036
US10918816 Expires Dec 14, 2035
US9415008*PED Expires Apr 6, 2035
US9066957*PED Expires Apr 6, 2035
US9066957 Expires Oct 6, 2034
US9415008 Expires Oct 6, 2034
US10195375*PED Expires Aug 14, 2031
US10195375 Expires Feb 14, 2031
Source: FDA Orange Book

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Patent Timeline

  • • Cliff: 2041
  • • 174 active patents

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Data Sources

FDA Approval: NDA208799 → Patents: FDA Orange Book → Trials: ClinicalTrials.gov →

Data sourced from official FDA and NIH databases. Click links to verify on original sources.