Clinical trial • Phase IV • Respiratory
DUPILUMAB for Chronic obstructive pulmonary disease
Phase IV trial of DUPILUMAB for Chronic obstructive pulmonary disease.
Overview
- Trial Therapeutic Area
- Respiratory
- Trial Disease
- Chronic obstructive pulmonary disease
- Trial Stage
- Phase IV
- Drug Modality
- Monoclonal antibody|Small molecule
Key dates
- Initial CTIS Submission Date
- 06-06-2025
- First CTIS Authorization Date
- 29-09-2025
Trial design
Randomised, matched placebo for test product (matched placebo for dupilumab); dose and schedule not specified in available data. background therapy: triple therapy (ics + laba + lama) required/stable; reliever medication: ventolin evohaler 100 micrograms as auxiliary/reliever.-controlled Phase IV trial in Austria, Denmark, France and others.
- Randomised
- Yes
- Comparator
- matched placebo for test product (matched placebo for Dupilumab); dose and schedule not specified in available data. Background therapy: triple therapy (ICS + LABA + LAMA) required/stable; reliever medication: Ventolin Evohaler 100 micrograms as auxiliary/reliever.
- Target Sample Size
- 252
- Trial Duration For Participant
- 168
Eligibility
Recruits 252 adults.
Inclusion criteria
- {"criterion_text":"- Current or former smokers with a smoking history of ≥10 pack-years\n- Moderate-to-severe COPD (post-BD FEV1/FVC ratio <0.70 and post- BD FEV1 % predicted >30% and ≤70%)\n- Medical Research Council Dyspnea Scale grade ≥2 or COPD assessment test (CAT) score ≥10\n- Global Initiative for Chronic Obstructive Lung Disease (GOLD) category E, Frequent or severe exacerbations\n- Background triple therapy (ICS + LABA + LAMA) for 3 months before randomization with a stable dose of medication for ≥1 month before Visit 1; dual therapy (LABA + LAMA) allowed if ICS is contraindicated\n- Evidence of Type 2 inflammation: Participants with blood eosinophils ≥300 cells/μL at screening or with blood eosinophils ≥150 cells/μL at Visit 1 (screening) and with a history of blood eosinophils ≥300 cells/μL within the past year during stable state (non-exacerbation).\n- Mucus score cutoff of ≥3"}
Exclusion criteria
- {"criterion_text":"- A current diagnosis of asthma according to the Global Initiative for Asthma diagnostic (GINA) guidelines, or documented history of asthma\n- Significant pulmonary disease other than COPD (eg, lung fibrosis, sarcoidosis, interstitial lung disease, pulmonary hypertension, bronchiectasis, Churg-Strauss Syndrome) or another diagnosed pulmonary or systemic disease associated with elevated peripheral eosinophil counts\n- Treatment with oxygen >4.0 L/min for ≥8 hours/day\n- Respiratory tract infection within 4 weeks before screening, or during the screening period\n- Diagnosis of α-1 anti-trypsin deficiency\n- Any biologic therapy (including experimental treatments and dupilumab)\n- Participants on treatment with mucolytics unless on stable therapy for >6 months"}
Endpoints
Primary endpoints
- {"endpoint_text":"- Change from baseline to Week 24 in global lung mucus score (UCSF mucus scoring)","definition_or_measurement_approach":"Change from baseline to Week 24 measured using the global lung mucus score (UCSF mucus scoring)."}
Secondary endpoints
- {"endpoint_text":"- Change from baseline to Week 24 in mucus volume for global lung by High-resolution Computed Tomography (HRCT)","definition_or_measurement_approach":"Change from baseline to Week 24 in mucus volume measured by HRCT."}
- {"endpoint_text":"- Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC by HRCT","definition_or_measurement_approach":"Change from baseline to Week 24 in trimmed distal airway wall thickness at TLC measured by HRCT."}
- {"endpoint_text":"- Change from baseline to Week 24 in airway resistance from R5 to R20 measured by Forced Oscillation Technique (FOT)","definition_or_measurement_approach":"Change from baseline to Week 24 in airway resistance (R5 to R20) measured by Forced Oscillation Technique (FOT)."}
- {"endpoint_text":"- Change from baseline to Week 24 in Reactance area (AX) measured by FOT","definition_or_measurement_approach":"Change from baseline to Week 24 in reactance area (AX) measured by FOT."}
- {"endpoint_text":"- Incidence of Treatment-Emergent Adverse Event (TEAE), Serious Adverse Event (SAE), and Adverse Event of Special Interest (AESI) including potentially clinically significant abnormalities","definition_or_measurement_approach":"Incidence of TEAEs, SAEs and AESIs including potentially clinically significant abnormalities as collected during the study."}
Recruitment
- Planned Sample Size
- 252
- Recruitment Window Months
- 38
- Consent Approach
- Informed consent is required. Subject information and informed consent form (L1) documents are provided in multiple country-specific languages (examples in the document list include English, German, French, Dutch, Hungarian, Italian, Polish, Spanish, Swedish). No explicit details on assent or age-specific consent processes are provided in the available CTIS data.
Geography
- Total Number Of Sites
- 40
- Total Number Of Participants
- 184
Austria
- Earliest CTIS Part Ii Submission Date
- 07-08-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 60
- Number Of Sites
- 3
- Number Of Participants
- 24
Sites
- Site Name
- Medizinische Universitaet Innsbruck
- Department Name
- Medizinische Universitaet Innsbruck
- Principal Investigator Name
- Judith Loeffler-Ragg
- Principal Investigator Email
- judith.loeffler-ragg@tirol-kliniken.at
- Contact Person Name
- Judith Loeffler-Ragg
- Contact Person Email
- judith.loeffler-ragg@tirol-kliniken.at
- Site Name
- Kepler Universitaetsklinikum GmbH
- Department Name
- Med Campus III - Universitätsklinik für Kinder- und Jugendheilkunde
- Principal Investigator Name
- Andreas Horner
- Principal Investigator Email
- Andreas.Horner@kepleruniklinikum.at
- Contact Person Name
- Andreas Horner
- Contact Person Email
- Andreas.Horner@kepleruniklinikum.at
- Site Name
- Stadt Wien Wiener Gesundheitsverbund
- Department Name
- Interne Abteilung Fur Lungenerkrankungen
- Principal Investigator Name
- Marie-Kathrin Breyer
- Principal Investigator Email
- marie-kathrin.breyer@gesundheitsverbund.at
- Contact Person Name
- Marie-Kathrin Breyer
- Contact Person Email
- marie-kathrin.breyer@gesundheitsverbund.at
Denmark
- Earliest CTIS Part Ii Submission Date
- 05-09-2025
- Latest Decision Or Authorization Date
- 30-09-2025
- Processing Time Days
- 25
- Number Of Sites
- 2
- Number Of Participants
- 8
Sites
- Site Name
- Lillebaelt Hospital
- Department Name
- Vejle Sygehus Lungemedicinsk Ambulatorium A650
- Principal Investigator Name
- Ole Hilberg
- Principal Investigator Email
- ole.hilberg@rsyd.dk
- Contact Person Name
- Ole Hilberg
- Contact Person Email
- ole.hilberg@rsyd.dk
France
- Earliest CTIS Part Ii Submission Date
- 29-07-2025
- Latest Decision Or Authorization Date
- 29-09-2025
- Processing Time Days
- 62
- Number Of Sites
- 9
- Number Of Participants
- 32
Sites
- Site Name
- Hospices Civils De Lyon
- Department Name
- Hôpital de la Croix-Rousse Service de Pneumologie
- Principal Investigator Name
- Gilles Devouassoux
- Principal Investigator Email
- gilles.devouassoux@chu-lyon.fr
- Contact Person Name
- Gilles Devouassoux
- Contact Person Email
- gilles.devouassoux@chu-lyon.fr
- Site Name
- Centre Hospitalier Universitaire De Lille
- Department Name
- CHU Lille - Institut Coeur Poumon
- Principal Investigator Name
- Thierry Perez
- Principal Investigator Email
- thierry.perez@chu-lille.fr
- Contact Person Name
- Thierry Perez
- Contact Person Email
- thierry.perez@chu-lille.fr
- Site Name
- Centre Hospitalier Universitaire Reims
- Department Name
- Hôpital Robert Debré Service des Maladies Respiratoires
- Principal Investigator Name
- Gaetan Deslee
- Principal Investigator Email
- gdeslee@chu-reims.fr
- Contact Person Name
- Gaetan Deslee
- Contact Person Email
- gdeslee@chu-reims.fr
- Site Name
- Centre Hospitalier Regional Et Universitaire De Brest
- Department Name
- Centre Hospitalier Régional Universitaire de Brest - Hôpital de la Cavale Blanche
- Principal Investigator Name
- Christophe Gut-Gobert
- Principal Investigator Email
- christophe.gut-gobert@chu-brest.fr
- Contact Person Name
- Christophe Gut-Gobert
- Contact Person Email
- christophe.gut-gobert@chu-brest.fr
- Site Name
- Centre Hospitalier Regional De Marseille
- Department Name
- Assistance Publique Hôpitaux de Marseille - Hôpital Nord
- Principal Investigator Name
- Pascal Chanez
- Principal Investigator Email
- pascal.chanez@univ-amu.fr
- Contact Person Name
- Pascal Chanez
- Contact Person Email
- pascal.chanez@univ-amu.fr
- Site Name
- Centre Hospitalier Universitaire De Montpellier
- Department Name
- Service des Maladies Respiratoires
- Principal Investigator Name
- Arnaud Bourdin
- Principal Investigator Email
- a-bourdin@chu-montpellier.fr
- Contact Person Name
- Arnaud Bourdin
- Contact Person Email
- a-bourdin@chu-montpellier.fr
- Site Name
- Assistance Publique Hopitaux De Paris
- Department Name
- GHU APHP-Sorbonne Université – Pitié-Salpêtrière Pneumologie
- Principal Investigator Name
- Capucine Morelot-Panzini
- Principal Investigator Email
- Capucine.morelot@aphp.fr
- Contact Person Name
- Capucine Morelot-Panzini
- Contact Person Email
- Capucine.morelot@aphp.fr
- Site Name
- Centre Hospitalier Universitaire Grenoble Alpes
- Department Name
- CHU Grenoble Alpes Pneumology
- Principal Investigator Name
- Bruno Degano
- Principal Investigator Email
- bdegano@chu-grenoble.fr
- Contact Person Name
- Bruno Degano
- Contact Person Email
- bdegano@chu-grenoble.fr
- Site Name
- Centre Hospitalier Universitaire De Bordeaux
- Department Name
- Groupe Hospitalier Sud - Hôpital Haut Lévêque
- Principal Investigator Name
- Maeva Zysman
- Principal Investigator Email
- maeva.zysman@chu-bordeaux.fr
- Contact Person Name
- Maeva Zysman
- Contact Person Email
- maeva.zysman@chu-bordeaux.fr
Germany
- Earliest CTIS Part Ii Submission Date
- 25-08-2025
- Latest Decision Or Authorization Date
- 30-09-2025
- Processing Time Days
- 36
- Number Of Sites
- 3
- Number Of Participants
- 8
Sites
- Site Name
- Velocity Clinical Research Germany GmbH
- Department Name
- Velocity Clinical Reasearch - Ahrensburg
- Principal Investigator Name
- Henrik Watz
- Principal Investigator Email
- h.watz@pulmoresearch.de
- Contact Person Name
- Henrik Watz
- Contact Person Email
- h.watz@pulmoresearch.de
- Site Name
- IKF Pneumologie GmbH & Co. KG
- Department Name
- IKF Institut für Klinische Forschung Mainz
- Principal Investigator Name
- Stephanie Korn
- Principal Investigator Email
- korn@ikf-pneumologie.de
- Contact Person Name
- Stephanie Korn
- Contact Person Email
- korn@ikf-pneumologie.de
- Site Name
- Institut fur Allergie und Asthmaforschung Berlin, IAAB
- Department Name
- Institut fur Allergie und Asthmaforschung Berlin
- Principal Investigator Name
- Matthias Kruell
- Principal Investigator Email
- kruell@pneumologie-berlin.de
- Contact Person Name
- Matthias Kruell
- Contact Person Email
- kruell@pneumologie-berlin.de
Hungary
- Earliest CTIS Part Ii Submission Date
- 29-07-2025
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 66
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Crodoctor Kft.
- Department Name
- Szalay Janos Rendelőintézet Tüdőgyógyászat
- Principal Investigator Name
- Edina Kurucz
- Principal Investigator Email
- drkuruczedina@gmail.com
- Contact Person Name
- Edina Kurucz
- Contact Person Email
- drkuruczedina@gmail.com
- Site Name
- Infer-Med Kft.
- Department Name
- Da Vinci Magánklinika
- Principal Investigator Name
- Marta Papp
- Principal Investigator Email
- drpappm@gmail.com
- Contact Person Name
- Marta Papp
- Contact Person Email
- drpappm@gmail.com
- Site Name
- University Of Debrecen
- Department Name
- Debreceni Egyetem Klinikai Központ
- Principal Investigator Name
- Ildiko Horvath
- Principal Investigator Email
- horvath.ildiko@med.unideb.hu
- Contact Person Name
- Ildiko Horvath
- Contact Person Email
- horvath.ildiko@med.unideb.hu
Italy
- Earliest CTIS Part Ii Submission Date
- 02-09-2025
- Latest Decision Or Authorization Date
- 01-10-2025
- Processing Time Days
- 29
- Number Of Sites
- 4
- Number Of Participants
- 16
Sites
- Site Name
- Azienda Ospedaliero-Universitaria San Luigi Gonzaga
- Department Name
- Azienda Sanitaria Ospedaliera San Luigi Gonzaga
- Principal Investigator Name
- Fabio Luigi Massimo Ricciardolo
- Principal Investigator Email
- fabioluigimassimo.ricciardolo@unito.it
- Contact Person Name
- Fabio Luigi Massimo Ricciardolo
- Contact Person Email
- fabioluigimassimo.ricciardolo@unito.it
- Site Name
- University Hospital Of Ferrara
- Department Name
- Unità Operativa di Pneumologia dell’Azienda Ospedaliero Universitaria di Ferrara
- Principal Investigator Name
- Alberto Papi
- Principal Investigator Email
- cemicef@unife.it
- Contact Person Name
- Alberto Papi
- Contact Person Email
- cemicef@unife.it
- Site Name
- Azienda Ospedaliero-Universitaria Senese
- Department Name
- Azienda Ospedaliera Universitaria Senese
- Principal Investigator Name
- Felice Perillo
- Principal Investigator Email
- felice.perillo@unisi.it
- Contact Person Name
- Felice Perillo
- Contact Person Email
- felice.perillo@unisi.it
- Site Name
- Azienda Unita' Locale Socio Sanitaria N. 2 Marca Trevigiana
- Department Name
- UOC Pneumologia
- Principal Investigator Name
- Francesco Menzella
- Principal Investigator Email
- francesco.menzella@ausl.re.it
- Contact Person Name
- Francesco Menzella
- Contact Person Email
- francesco.menzella@ausl.re.it
Spain
- Earliest CTIS Part Ii Submission Date
- 28-08-2025
- Latest Decision Or Authorization Date
- 03-10-2025
- Processing Time Days
- 36
- Number Of Sites
- 5
- Number Of Participants
- 24
Sites
- Site Name
- Hospital Universitario Central De Asturias
- Department Name
- Hospital Universitario Central de Asturias
- Principal Investigator Name
- Marta Iscar Urrutia
- Principal Investigator Email
- martaiscar@gmail.com
- Contact Person Name
- Marta Iscar Urrutia
- Contact Person Email
- martaiscar@gmail.com
- Site Name
- Hospital Universitario Fundacion Jimenez Diaz
- Department Name
- Hospital Universitario Fundación Jiménez Díaz
- Principal Investigator Name
- Carolina Gotera
- Principal Investigator Email
- carolina.gotera@fjd.es
- Contact Person Name
- Carolina Gotera
- Contact Person Email
- carolina.gotera@fjd.es
- Site Name
- Hospital Universitario Quironsalud Madrid
- Department Name
- Hospital Universitario Quirón Salud Madrid
- Principal Investigator Name
- Jose Maria Echave-Sustaeta Maria-Tomé
- Principal Investigator Email
- jose.echave@quironsalud.es
- Contact Person Name
- Jose Maria Echave-Sustaeta Maria-Tomé
- Contact Person Email
- jose.echave@quironsalud.es
- Site Name
- Pectus Respiratory Health S.L.
- Department Name
- Pectus Respiratoy Health S.L. (BCN)
- Principal Investigator Name
- Juan Roldan-Sanchez
- Principal Investigator Email
- juan.roldan@giromedinstitute.com
- Contact Person Name
- Juan Roldan-Sanchez
- Contact Person Email
- juan.roldan@giromedinstitute.com
- Site Name
- Hospital Universitario Marques De Valdecilla
- Department Name
- Hospital Universitario Marqués de Valdecilla
- Principal Investigator Name
- Carlos Antonio Amado Diago
- Principal Investigator Email
- carlosantonio.amado@scsalud.es
- Contact Person Name
- Carlos Antonio Amado Diago
- Contact Person Email
- carlosantonio.amado@scsalud.es
Netherlands
- Earliest CTIS Part Ii Submission Date
- 17-09-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 19
- Number Of Sites
- 5
- Number Of Participants
- 20
Sites
- Site Name
- Universitair Medisch Centrum Groningen
- Department Name
- Universitair Medisch Centrum Groningen
- Principal Investigator Name
- Maarten van den Berge
- Principal Investigator Email
- m.van.den.berge@umcg.nl
- Contact Person Name
- Maarten van den Berge
- Contact Person Email
- m.van.den.berge@umcg.nl
- Site Name
- Canisius Wilhelmina Ziekenhuis
- Department Name
- Department of Pulmonary Medicine
- Principal Investigator Name
- Rob Janssen
- Principal Investigator Email
- rob.janssen@cwz.nl
- Contact Person Name
- Rob Janssen
- Contact Person Email
- rob.janssen@cwz.nl
- Site Name
- Spaarne Gasthuis Stichting
- Department Name
- Spaarne Gasthuis, Haarlem Zuid
- Principal Investigator Name
- Folkert Brijker
- Principal Investigator Email
- fbrijker@spaarnegasthuis.nl
- Contact Person Name
- Folkert Brijker
- Contact Person Email
- fbrijker@spaarnegasthuis.nl
- Site Name
- Sint Franciscus Vlietland Groep Stichting
- Department Name
- Franciscus Gasthuis & Vlietland, Locatie Gasthuis
- Principal Investigator Name
- Yasemin Turk
- Principal Investigator Email
- Yasemin.turk@franciscus.nl
- Contact Person Name
- Yasemin Turk
- Contact Person Email
- Yasemin.turk@franciscus.nl
- Site Name
- Radboud universitair medisch centrum Stichting
- Department Name
- Radboud Universitair Medisch Centrum
- Principal Investigator Name
- Bram Van Den Borst
- Principal Investigator Email
- Bram.vandenBorst@radboudumc.nl
- Contact Person Name
- Bram Van Den Borst
- Contact Person Email
- Bram.vandenBorst@radboudumc.nl
Poland
- Earliest CTIS Part Ii Submission Date
- 29-08-2025
- Latest Decision Or Authorization Date
- 06-10-2025
- Processing Time Days
- 38
- Number Of Sites
- 3
- Number Of Participants
- 20
Sites
- Site Name
- Centrum Medycyny Oddechowej Mroz Sp. j.
- Department Name
- Centrum Medycyny Oddechowej Spolka Jawna
- Principal Investigator Name
- Robert Marek Mroz
- Principal Investigator Email
- robmroz@wp.pl
- Contact Person Name
- Robert Marek Mroz
- Contact Person Email
- robmroz@wp.pl
- Site Name
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii Uczulen
- Department Name
- Specjalistyczny Niepubliczny Zaklad Opieki Zdrowotnej Alergologia Plus Osrodek Diagnostyki I Terapii
- Principal Investigator Name
- Michal Springer
- Principal Investigator Email
- michal.springer.pl@gmail.com
- Contact Person Name
- Michal Springer
- Contact Person Email
- michal.springer.pl@gmail.com
- Site Name
- Ostrowieckie Centrum Medyczne Anna Olech Cudzik Krzysztof Cudzik s.c.
- Department Name
- Ostrowieckie Centrum Medyczne
- Principal Investigator Name
- Anna Olech-Cudzik
- Principal Investigator Email
- annacudzik@cudmed.pl
- Contact Person Name
- Anna Olech-Cudzik
- Contact Person Email
- annacudzik@cudmed.pl
Sweden
- Earliest CTIS Part Ii Submission Date
- 18-06-2025
- Latest Decision Or Authorization Date
- 26-11-2025
- Processing Time Days
- 161
- Number Of Sites
- 3
- Number Of Participants
- 16
Sites
- Site Name
- Region Skane Skanes Universitetssjukhus
- Department Name
- Skånes Universitetssjukhus FoUU Lungmedicin, Lung- och allergiforskning
- Principal Investigator Name
- Jens Richter
- Principal Investigator Email
- jens.richter@med.lu.se
- Contact Person Name
- Jens Richter
- Contact Person Email
- jens.richter@med.lu.se
- Site Name
- Sahlgrenska University Hospital-Vaestra Goetalandsregionen
- Department Name
- Sahlgrenska Universitetssjukhuset
- Principal Investigator Name
- Lowie Vanfleteren
- Principal Investigator Email
- lowie.vanfleteren@vgregion.se
- Contact Person Name
- Lowie Vanfleteren
- Contact Person Email
- lowie.vanfleteren@vgregion.se
- Site Name
- Karolinska University Hospital
- Department Name
- Karolinska Universitetssjukhuset - Huddinge
- Principal Investigator Name
- Valentyna Yasinska
- Principal Investigator Email
- valentyna.yasinska@ki.se
- Contact Person Name
- Valentyna Yasinska
- Contact Person Email
- valentyna.yasinska@ki.se
Sponsor
Primary sponsor
- Full Name
- Sanofi-Aventis Recherche & Developpement
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- France
Contract research organisations
- Name
- Endpoint Clinical Inc.
- Responsibilities
- code 3
- Name
- Parexel International Services India Private Limited
- Responsibilities
- code 8
- Name
- Eresearchtechnology Inc.
- Responsibilities
- Imaging reading; code 7
Third parties
- {"country":"United States","full_name":"Endpoint Clinical Inc.","duties_or_roles":"code 3","organisation_type":"Pharmaceutical company"}
- {"country":"France","full_name":"Inato","duties_or_roles":"code 2","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Empatica Inc.","duties_or_roles":"Digital biomarker capture","organisation_type":"Pharmaceutical company"}
- {"country":"Spain","full_name":"Alcura Health Espana S.A.","duties_or_roles":"code 14","organisation_type":"Pharmaceutical company"}
- {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"AxMP and ancillary material management","organisation_type":"Pharmaceutical company"}
- {"country":"United States","full_name":"Eresearchtechnology Inc.","duties_or_roles":"Imaging reading; code 7","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"ESMS Global Limited","duties_or_roles":"Centralized 24-Hour Emergency System: eSMS","organisation_type":"Pharmaceutical company"}
- {"country":"India","full_name":"Parexel International Services India Private Limited","duties_or_roles":"code 8","organisation_type":"Pharmaceutical company"}
- {"country":"United Kingdom","full_name":"Breatheox Limited","duties_or_roles":"Cough night monitoring","organisation_type":"Pharmaceutical company"}
Investigational products
- Investigational Product Name
- Dupilumab
- Active Substance
- DUPILUMAB
- Modality
- Monoclonal antibody
- Routes Of Administration
- SUBCUTANEOUS USE
- Route
- SUBCUTANEOUS USE
- Authorisation Status
- prodAuthStatus 1
- Maximum Dose
- Max daily dose 300 mg; max total dose 3600 mg
- Investigational Product Name
- matched placebo for test product
- Modality
- Other
- Investigational Product Name
- Ventolin Evohaler 100 micrograms
- Active Substance
- SALBUTAMOL
- Modality
- Small molecule
- Routes Of Administration
- INHALATIONAL ROUTE
- Route
- INHALATIONAL ROUTE
- Authorisation Status
- Marketing authorisation PL 10949/0274 (prodAuthStatus 2)
- Maximum Dose
- Max daily dose 10 (as listed)
- Combination Treatment
- Yes
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