Efficacy and Safety of Tanimilast in Asthmatics uNcontrolled on ICS-containinG backgrOund Maintenance Therapy

Uncontrolled Asthma Clinical Trial

— TANGO  

Official title:

A 52-week, Randomised, Double Blind, Multicentre, 2-arm Parallel Group Trial Assessing Efficacy of CHF6001 (Total Daily Dose 3200μg) Dry Powder Inhaler (DPI) add-on to Maintenance Medium or High Dose of Inhaled Corticosteroids in Combination With Long-acting ß2-agonists in Subjects With Uncontrolled Asthma

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06029595
• Other study ID #: CLI-06001AA2-01
• Secondary ID: EUCT: 2022-50220
• Status: Recruiting
• Phase: Phase 2
• Start date: November 26, 2023
• Est. completion date: December 18, 2025

Study information

• Verified date: April 2024
• Source: Chiesi Farmaceutici S.p.A.
• Contact: Chiesi Clinical Trial info
• Phone: +3905212791
• Email: clinicaltrials_info[@]chiesi.Com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy and safety of CHF6001 (Tanimilast) as add-on to maintenance of inhaled corticosteroids in combination with Long-acting ß2-agonists in the target patient population. (TANGO)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 464
• Est. completion date: December 18, 2025
• Est. primary completion date: December 18, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

Inclusion Criteria:

1. Subject's written informed consent

2. Male or female subjects aged =18 and =75 years

3. A documented history of physician-diagnosed asthma for at least 1 year and with diagnosis before the age of 50 years

4. Stable asthma therapy: a stable maintenance treatment with medium to high dose of inhaled corticosteroids plus long acting ß2 agonists for at least 3 months prior to screening

5. A prebronchodilator FEV1 =80% of the predicted normal value

6. Bronchodilator responsiveness after inhalation of salbutamol or equivalent

7. Evidence of poorly controlled or uncontrolled asthma as based on an ACQ-7 score =1.5

8. History of asthma exacerbations : at least 1 asthma exacerbation leading to hospitalisation or 2 or more asthma exacerbations within the last 12 months

9. A cooperative attitude and ability to use inhalers and to comply with study procedures

Exclusion Criteria:

1. e-Diary completion compliance <75% during run-in

2. History of near fatal asthma or of a past hospitalisation for asthma in intensive care unit

3. Recent exacerbation or respiratory tract infection within 4 weeks prior to screening visit or during the run-in period

4. Subjects using systemic corticosteroids medication in the 4 weeks or slow-release corticosteroids in the 12 weeks prior to randomisation

5. Asthma requiring use of biologics

6. Respiratory disorders other than asthma: subjects with known respiratory disorders other than asthma

7. Subjects with a history of lung volume resection

8. Current smokers, ex-smokers with a smoking history of =10 pack-years or current use of inhaled or oral cannabis products.

9. Subjects with cancer or history of cancer

10. Subjects with cardiovascular diseases

11. Subjects with any abnormal and clinically significant 12-lead ECG

12. Subjects with previous medical history, evidence of an uncontrolled intercurrent illness, or any clinically relevant abnormal findings in haematology, clinical chemistry, or urinalysis

13. Subjects with a diagnosis of depression, generalised anxiety disorder, suicidal ideation or behaviour

14. Patients mentally or legally incapacitated or patients accommodated in an establishment

15. Subjects with liver diseases

16. Drugs with hepatoxicity potential

17. Subjects with contra-indications to IMPs:

18. Subjects with history alcohol/drug abuse

19. Subjects with major surgery in the 3 months prior to screening visit or planned during the trial

20. Subjects treated with non-potassium sparing diuretics, nonselective ß-blocking drugs, quinidine, quinidine like anti-arrhythmic, or any medication with a QTc prolongation potential or a history of QTc prolongation

21. Subjects treated with monoamine oxidase inhibitors (MAOIs) and tricyclic anti-depressants

22. Subjects receiving any therapy that could interfere with the study drugs

23. Participation in another investigational trial

24. Documented coronavirus disease 2019 (COVID-19) diagnosis within the last 2 weeks

25. Subjects having received a vaccination within 2 weeks prior to screening or during the run-in period.

26. For females only: pregnant or lactating women

Related Conditions & MeSH terms

• Asthma
• Uncontrolled Asthma

Intervention

Drug:
• Experimental: CHF6001 3200 µg
800 µg/actuation - 2 inhalations of CHF6001 800 µg twice daily (BID) total daily dose 3200 µg
• Placebo Comparator: CHF6001 Placebo
2 inhalations of CHF6001 matching placebo BID

Locations

Country	Name	City	State
Argentina	Site 032004 - CARE - Centro de Alergia y Enfermedades Respiratorias	Buenos Aires
Argentina	Site 032014 - Instituto de Investigaciones en Alergia y Enfermedades Respiratorias (INAER)	Buenos Aires
Argentina	Site 032008 - Mautalen Salud e Investigacion	Ciudad Autonoma de Buenos Aires
Argentina	Site 032003 -Fundacion Respirar (Centro Medico Dra. De Salvo) - Instituto Argentino de Investigaciones Clinicas (IAIC) S.R.L	Ciudad de Buenos Aires
Argentina	Site 032005 - National University of Cordoba - Rusculleda Foundation - Instituto DAMIC	Córdoba
Argentina	Site 032001 - Instituto de Enfermedades Respiratorias e Investigacion Medica- IERIM	Florencio Varela
Argentina	Site 032010 - Centro Platense en Investigaciones Respiratorias - CEPIR	La Plata
Argentina	Site 032013 - Centro de Investigacion Medico Lanus-CIMEL CHAHIN CHAHIN S.A	Lanús
Argentina	Site 032006 -Institute Fundacion Enfisema - Instituto Ave Pulmo; Hospital Privado de Comunidad (HPC)	Mar Del Plata
Argentina	Site 032021 - Centro De Investigaciones Medicas Mar Del Plata	Mar Del Plata
Argentina	Site 032002 -Consultorios Medicos Dr Isaac Scherbovsky - Fundacion Scherbovsky	Mendoza
Argentina	Site 032009 - Centro Medico INSARES	Mendoza
Argentina	Site 032011 - Centro Privado de Medicina Respiratoria de Parana - CPMR	Parana
Argentina	Site 032016 - Centro Respiratorio Infantil	Rosario
Argentina	Site 032019 - Servicio de Investigacion de Patologias Alergicas del Instituto ABC - Rosario	Rosario
Argentina	Site 032015 - Fundacion de Estudios Clinicos de Consultorio Integrados Rosario	San Miguel De Tucumán
Argentina	Site 032018 - Instituto de Investigaciones en Patologias Respiratorias	San Miguel De Tucumán
Argentina	Site 032022 - Clinica Mayo de Urgencias Medicas Cruz Blanca SRL	San Miguel De Tucumán
Argentina	Site 032020 - Instituto Especialidades de la Salud Rosario - Clinica del Torax	Santa Fe	La
Argentina	Site 032012 - Instituto Del Buen Aire	Santa Fe de la Vera Cruz
Argentina	Site 032017 - Centro Medico de Enfermedades Respiratorias (CEMER)	Vicente López
Bulgaria	Site 100012 - Medical Center Asklepii OOD	Dupnitsa
Bulgaria	Site 100005 _MHAT Dr. Tota Venkova AD	Gabrovo
Bulgaria	Site 100011 - Medical Center Pulmo-2018 EOOD	Haskovo
Bulgaria	Site 100021 - MC Zdrave 1	Kozloduy
Bulgaria	Site 100003 - """DCC 1 - Pernik"" EOOD"	Pernik
Bulgaria	Site 100010 - Medical Center FAMA	Plovdiv
Bulgaria	Site 100017 - MHAT Sveti Panteleymon EOOD	Plovdiv
Bulgaria	Site 100024 - Medical center Respiro	Razgrad
Bulgaria	Site 100006 _ Ambulatory For Specialized Outpatient Medical Care - Individual Practice - Dr. Nikolay Evgeniev Ruse Ltd	Ruse
Bulgaria	Site 100014 -SBALPFZ - Ruse EOOD	Ruse
Bulgaria	Site 100029 - DCC 1 Sevlievo	Sevlievo
Bulgaria	Site 100004 - MHAT Dr. Ivan Seliminski AD	Sliven
Bulgaria	Site 100028 - Smolyan Clinical Research Center	Smolyan
Bulgaria	100001 -5th MHAT - Sofia EAD	Sofia
Bulgaria	Site 100001- 5th MHAT - Sofia EAD	Sofia
Bulgaria	Site 100002 _MHAT St. Ekaterina Dimitrovgrad	Sofia
Bulgaria	Site 100008 _Diagnostic Consultative Center Convex Ltd	Sofia
Bulgaria	Site 100013 - MHAT Lyulin EAD	Sofia
Bulgaria	Site 100018 - Medical Center Excelsior Ltd	Sofia
Bulgaria	Site 100019 - Aleksandrovska University Hospital	Sofia
Bulgaria	Site 100020 -Medical Centre N. I. Pirogov EOOD	Sofia
Bulgaria	Site 100023 - University First Multiprofile Hospital for Active treatment-Sofia EAD	Sofia
Bulgaria	Site 100026 - Military Medical Academy (MMA)	Sofia
Bulgaria	Site 100030 - Medical Center Hera EOOD	Sofia
Bulgaria	Site 100009 - Medical Center Kissiovi	Varna
Bulgaria	Site 100027 - Medical Center Research Expert	Varna
Bulgaria	Site 100007 _SHATPPD Vratsa	Vratsa
Czechia	Site 203001 -MUDr. I. Cierna Peterova s.r.o.	Brandýs Nad Labem
Czechia	Site 203008 - Fakultni nemocnice Brno	Brno
Czechia	Site 203002 - MediTrial s.r.o.	Jindrichuv Hradec
Czechia	Site 203009 - Alergologie Nemcova s.r.o	Liskovec
Czechia	203004 -Nemocnice Mesice	Mesice
Czechia	Site 203003 - Plicni Stredisko Teplice, s.r.o.	Teplice
Czechia	Site 203005 - Ambulance Pneumologie a Ftizeologie	Varnsdorf
Georgia	268007 - TSMU & Ingorokva High Medical Technologies University Clinic	Tbilisi
Georgia	Site 268001 - Chapidze Emergency Cardiology Center	Tbilisi
Georgia	Site 268002 - JSC German Hospital	Tbilisi
Georgia	Site 268003 - French Joint Hepatology Clinic Hepa	Tbilisi
Georgia	Site 268004 - LTD Helsicore	Tbilisi
Georgia	Site 268005 - LLC Medi Club Georgia	Tbilisi
Georgia	Site 268006 - The Firsts University Clinic of Tbilisi State Medical University	Tbilisi
Germany	Site 276004 - RCMS	Berlin
Germany	Site 276012 - Institut fuer Allergie- und Asthmaforschung Berlin	Berlin
Germany	Site 276013 - MECS Research	Berlin
Germany	Site 276010 - Office of Dr. Thomas Ginko, MD	Bonn
Germany	Site 276014 - MECS Cottbus GmbH	Cottbus
Germany	Site 276019 - Praxis Dr. Eckhardt	Delitzsch
Germany	Site 276007 - IKF Institut fuer klinische Forschung Frankfurt	Frankfurt am Main
Germany	Site 276008 - Office of Dr. med. Claus Keller MD	Frankfurt am Main
Germany	Site 276003 - ME Clinical Respiratory Research Hamburg	Hamburg
Germany	Site 276015 - Velocity Clinical Research Hamburg GmbH	Hamburg
Germany	Site 276002 - Pneumologicum im Suedstadtforum - Hannover	Hannover
Germany	Site 276009 - Velocity Clinical Research Leipzig GmbH	Leipzig
Germany	Site 276011 - POIS Sachsen GmbH	Leipzig
Germany	Site 276020 - BAG Prof. Gerhard Hoheisel/Dr. Andreas Bonitz Praxis für Pneumologie und Allergologie-Studienzentrum	Leipzig
Germany	Site 276006 - IKF Pneumologie Mainz, Helix Medical Excellence Center Mainz	Mainz
Germany	Site 276001 - Studienzentrum Muenchen-West; Gemeinschaftspraxis fuer Lungen- und Bronchialheilkunde Prof. Dr. med. Rainald Fischer und Dr. med. Michael Baborka	Muenchen
Germany	Site 276017 - Office of Dr. Christian Schlenska MD	Peine
Germany	Site 276021 - Pneumologische Gemeinschaftspraxis Rheine	Rheine
Germany	Site 276022 - Universitaetsmedizin Rostock	Rostock
Germany	Site 276016 - Praxisgemeinschaft in Saalfeld - HNO	Saalfeld /Saale
Germany	Site 276018 - Siteworks Prufzentrum Schleswig-RespiRatio	Schleswig
Germany	Site 276005 - Lungenzentrum Ruhr - Praxis fuer Lungenheilkunde	Witten
Hungary	Site 348002 - Clinexpert SMO	Budapest
Hungary	Site 348006 - Bajcsy-Zsilinszky Hospital	Budapest
Hungary	Site 348003 - ClinTrial-Kenezy Hospital Institute of Clinical Pharmacology Infectology and Allergology	Debrecen
Hungary	Site 348001 - Koch Robert Korhaz es Rendelointezet	Edeleny
Hungary	Site 348005 - Szalay Janos Rendelointezet	Hajdúnánás
Hungary	Site 348004 - INFER-MED Kft. Da Vinci Maganklinika	Pecs
Italy	Site 380002 - AOU-S.Orsola-Malpighi - Universita degli Studi di Bologna	Bologna
Italy	Site 380003 - Azienda Ospedaliero Universitaria OO RR di Foggia	Foggia
Italy	Site 380001 - SC Pneumologia -Fondazione IRCCS Policlinico San Matteo	Pavia
Italy	Site 380006 - Azienda Ospedaliero Universitaria Pisana - Stabilimento Ospedaliero di Santa Chiara	Pisa
Italy	Site 380005 - Ospedale Fatebenefratelli Isola Tiberina Gemelli Isola	Roma
Italy	Site 380004 - Fondazione Salvatore Maugeri I.R.C.C.S. - Istituto Scientifico di Tradate	Tradate
Korea, Republic of	Site 410003 - Hallym University Sacred Heart Hospital	Anyang-si
Korea, Republic of	Site 410012 - Chungbuk National University Hospital (CBNUH)	Cheongju-si
Korea, Republic of	Site 410010 - Yeungnam University Medical Center	Daegu
Korea, Republic of	Site 410014 - The Catholic University of Korea, Incheon St. Mary's Hospital	Incheon
Korea, Republic of	Site 410004 - Jeonbuk National University Hospital	Jeonju
Korea, Republic of	Site 410001 - Konkuk University Medical Center	Seoul
Korea, Republic of	Site 410002 - The Catholic University of Korea, Seoul St. Marys Hospital	Seoul
Korea, Republic of	Site 410005 - Korea University Guro Hospital	Seoul
Korea, Republic of	Site 410006 - Asan Medical Center (AMC)	Seoul
Korea, Republic of	Site 410007 - Kangbuk Samsung Hospital	Seoul
Korea, Republic of	Site 410008 - Severance Hospital, Yonsei University Health System	Seoul
Korea, Republic of	Site 410013 - Chung-Ang University College of Medicine - Chung-Ang University Hopital (CAUH)	Seoul
Korea, Republic of	Site 410009 - Ajou University Hospital	Suwon-si
Korea, Republic of	Site 410011 - Yonsei University Wonju Severance Christian Hospital	Wonju
Latvia	Site 428005 - Balvi and Gulbene hospital union	Balvi
Latvia	Site 428008 - Dubultu Poliklinika	Jurmala
Latvia	Site 428001 - Pauls Stradins Clinical University Hospital	Riga
Latvia	Site 428002 - Consilium Medicum SIA	Riga
Latvia	Site 428003 - Latvian University Medical Postgraduate Institute	Riga
Latvia	Site 428006 - RiGa 1st Hospital	Riga
Latvia	Site 428007 - SIA RAKUS	Riga
Lithuania	Site 440002 - Hospital of Lithuanian University of Health Sciences Kauno klinikos	Kaunas
Lithuania	Site 440003 - LSMU Kauno ligonine (Kaunas Hospital of the Lithuanian University of Health Sciences)	Kaunas
Lithuania	Site 440006 - CD8 Klinika	Kaunas
Lithuania	Site 440007 - Republic Hospital Of Klaipeda (Respublikine Klaipedos ligonine)	Klaipeda
Lithuania	Site 440005 - PI Republican Siauliai Hospital	Siauliai
Lithuania	Site 440001 - Viesoji Istaiga Antakalnio poliklinika	Vilnius
Poland	Site 616011 - Centrum Medycyny Oddechowej, Mroz Spolka Jawna	Bialystok
Poland	Site 616017 - NZOZ Przychodnia Vitamed	Bydgoszcz
Poland	Site 616024- Mital Site	Elblag
Poland	Site 616015 - Centrum Medyczne CLW-MED Aneta Cichomska i Joanna Luka-Wendrowska	Grudziadz
Poland	Site 616020 - Pro Familia Altera Sp. z o.o.	Katowice
Poland	Site 616001 - Malopolskie Centrum Alergologii Sp z o.o	Krakow
Poland	Site 616018 - Prywatna Praktyka Lekarska Adam Smialowski - Intermed Ksawerów	Ksawerow
Poland	616007 - ETG Lodz	Lodz
Poland	Site 616009 - Samodzielny Publiczny Zaklad Opieki Zdrowotnej Uniwersytecki Szpital Kliniczny Nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi	Lódz
Poland	Site 616021 -IP Clinic Sp. z o.o.	Lódz
Poland	Site 616010 - Centrum Diagnostyczno-Terapeutyczne (CDT) Medicus Sp.z o.o.	Lubin
Poland	Site 616008 - Centrum Alergologii Specjalistyczna Przychodnia Alergologiczna	Lublin
Poland	Site 616025 - MS Pneumed Janusz Milanowski, Katarzyna Szmygin-Milanowska Spolka Jawna	Lublin
Poland	Site 616013 - Ostrowieckie Centrum Medyczne Spolka Cywilna Anna Olech-Cudzik, Krzysztof Cudzik	Ostrowiec Swietokrzyski
Poland	Site 616002 - Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) Allmed - Regionalne Centrum Leczenia Chorob Pluc i Alergii	Piekary Slaskie
Poland	Site 616006 - Centrum Alergologii Teresa Hofman Sp.z.o.o	Poznan
Poland	Site 616019 - Alergologia Plus	Poznan
Poland	Site 616023 - Specjalistyczna Przychodnia Lekarska Alergo-Med Sp. z o.o	Poznan
Poland	Site 616014 - Pawlukiewicz Malgorzata Prywatny Gabinet Lekarski	Rzeszow
Poland	Site 616005 - Niepubliczny Zaklad Opieki Zdrowotnej (NZOZ) - Poradnia Chorob Pluc	Slupsk
Poland	Site 616004 - Centrum Medyczne Lucyna Andrazej Dymek - Strzelce Opolskie	Strzelce Opolskie
Poland	Site 616003 - Lekarze Specjalisci - J. Malolepszy i Partnerzy	Wroclaw
Poland	Site 616012 - Centrum Badan Klinicznych Piotr Napora Lekarze Spolka Partnerska, Centrum Badan Klinicznych Osrodek Badan Wczesnej Fazy	Wroclaw
Poland	Site 616016 - Michal Bogacki Dobrostan	Wroclaw
Romania	Site 642005 - Angisan grup srl	Bragadiru
Romania	Site 642001 6 Centrul Medical de Diagnostic si Tratament Neomed	Brasov
Romania	Site 642002 - Institute of Pneumology 'Marius Nasta'	Bucuresti
Romania	Site 642004 - Clinical Hospital Of Pneumology Leon Daniello	Cluj-Napoca
Romania	Site 642007 - ICRH Prof DR Octavian Fodor, Sectia Medicina Interna si Ambulator Alergologie	Cluj-Napoca
Romania	Site 642003 - Spitalul De Boli Infectioase Victor Babes, Craiova	Craiova
Romania	Site 642008 - SPITALUL CLINIC DE PNEUMOFTIZIOLOGIE IASI, Sectia Clinica I de Pneumologie	Iasi
Romania	Site 642006 - Fundatia Cardioprevent	Timisoara
Romania	Site 642009 - Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Dr. Victor Babes	Timisoara
South Africa	Site 710005 - Worthwhile Clinical Trials	Benoni
South Africa	Site 710013 - Office of Dr. Agatha Cathrine Wilhase, MD	Boksburg
South Africa	Site 710003 - Office of Dr. ZFA Vawda MD	Durban
South Africa	Site 710004 - Synapta Clinical Research Center	Durban
South Africa	Site 710012 - CRISMO Research Centre	Germiston
South Africa	Site 710015 - University Of The Witwatersrand	Johannesburg
South Africa	Site 710006 - Langeberg Medicross Medical Centre	Kraaifontein
South Africa	Site 710002 - Lenmed- Ahmed Kathrada Private Hospital	Lenasia
South Africa	Site 710007 - Ubuntu Clinical Research	Lenasia
South Africa	Site 710001 - Emmed Research- Jakaranda Hospital	Pretoria
South Africa	Site 710009 - Global Clinical Trials	Pretoria
South Africa	Site 710011 - Busamed Paardevlei Hospital	Somerset West
South Africa	Site 710014 - University Of Stellenbosch	Stellenbosch
South Africa	Site 710010 - Limpopo Clinical Research Initiative	Thabazimbi
South Africa	Site 710008 - Welkom Clinical Trial Centre	Welkom
Spain	Site 724005 - Clinica Mi Tres Torres Barcelona	Barcelona
Spain	Site 724008 - Hospital del SAS de Jerez de la Frontera	Jerez De La Frontera
Spain	Site 724007 - Hospital General Universitario Gregorio Maranon (HGUGM) - Instituto de Investigacion Sanitaria Gregorio Maranon (IiSGM)	Madrid
Spain	Site 724002 - Servicio Andaluz de Salud Consejeria de Salud - Hospital Universitario Virgen de la Victoria	Málaga
Spain	Site 724004 - Hospital Universitario Marqués de Valdecilla	Santander
Spain	Site 724006 - Complejo Hospitalario Universitario De Santiago	Santiago De Compostela
Spain	Site 724003 - Hospital La Plana	Vila-Real
Spain	Site 724001 - Hospital Universitario Miguel Servet	Zaragoza

Sponsors (1)

Lead Sponsor	Collaborator
Chiesi Farmaceutici S.p.A.

Countries where clinical trial is conducted

Argentina,  Bulgaria,  Czechia,  Georgia,  Germany,  Hungary,  Italy,  Korea, Republic of,  Latvia,  Lithuania,  Poland,  Romania,  South Africa,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Asthma exacerbation over 52 weeks of treatment	Number of Asthma exacerbation over 52 weeks of treatment (Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization)	Over 52 weeks
Secondary	Time to first asthma exacerbation;	Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization	Up to 52 weeks
Secondary	Number of asthma exacerbation and asthma worsening over 52 weeks of treatment	Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization; Asthma worsening defined as moderate asthma exacerbation.	Up to 52 weeks
Secondary	Time to first asthma exacerbation or asthma worsening	Asthma exacerbations defined as severe event with worsening of asthma requiring at least 3 days of SCS use with or without emergency visit or hospitalization; Asthma worsening defined as moderate asthma exacerbation.	Up to 52 weeks
Secondary	ACQ-7 responders	ACQ-7 responders at Week 4, Week 26 and Week 52 (i.e., subjects showing improvement from baseline in ACQ-7 score of =0.5 units);	week 4, week 26 and week 52
Secondary	Change from baseline in ACQ-7 and ACQ-6	Change from baseline in ACQ-7 and ACQ-6 at Week 4, Week 26 and Week 52	week 4, week 26 and week 52
Secondary	Change from baseline in Mini-AQLQ	Change from baseline in Mini-AQLQ at Week 4, Week 26 and Week 52	week 4, week 26 and week 52
Secondary	Change from baseline in pre-dose FEV1	Change from baseline in pre-dose FEV1 at Week 4, Week 26 and Week 52;	week 4, week 26 and week 52
Secondary	Change from baseline in pre-dose FVC	Change from baseline in pre-dose FVC at Week4, Week 52 and Week 26;	Week4, Week 52 and Week 26
Secondary	Change from baseline (run-in period) to each inter-visit period and to the entire treatment period in pre dose morning/evening PEF;		Up to 52 weeks
Secondary	Change from baseline to each inter-visit period and to the entire treatment period in the average rescue medication use (number of puffs/day) and asthma symptoms score		Up to 52 weeks
Secondary	Change from baseline to each inter-visit period and to the entire treatment period in the percentage of rescue medication-free days, asthma symptoms-free days and asthma control days.		Up to 52 weeks