- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02892344
Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
A Multi-center, Randomized, 12-week Treatment, Doubleblind Study to Assess the Efficacy and Safety of QMF149 (150/80 Microgram) Compared With MF Twisthaler® (200 Microgram) in Adult and Adolescent Patients With Asthma
The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d.
delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Bulgaria, Bulgaria
- Novartis Investigative Site
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Pleven, Bulgaria, 5800
- Novartis Investigative Site
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Stara Zagora, Bulgaria, 6000
- Novartis Investigative Site
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Santiago, Chile
- Novartis Investigative Site
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Santiago, Chile, 8380453
- Novartis Investigative Site
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Vina del Mar, Chile, 2520594
- Novartis Investigative Site
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Region Metropolitana
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Santiago, Region Metropolitana, Chile, 7500692
- Novartis Investigative Site
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Bogota, Colombia
- Novartis Investigative Site
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Bucaramanga, Colombia
- Novartis Investigative Site
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Medellin, Colombia
- Novartis Investigative Site
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Antioquia
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Medellin, Antioquia, Colombia, 0050010
- Novartis Investigative Site
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Cundinamarca
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Bogota, Cundinamarca, Colombia, 110911
- Novartis Investigative Site
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Kohtla-Jarve, Estonia, 30322
- Novartis Investigative Site
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Tallinn, Estonia, 13419
- Novartis Investigative Site
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Tartu, Estonia, 51014
- Novartis Investigative Site
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Bad Woerishofen, Germany, 86825
- Novartis Investigative Site
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Berlin, Germany, 10119
- Novartis Investigative Site
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Bochum, Germany, 44791
- Novartis Investigative Site
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Darmstadt, Germany, 64283
- Novartis Investigative Site
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Frankfurt, Germany, 60596
- Novartis Investigative Site
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Gauting, Germany, 82131
- Novartis Investigative Site
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Hamburg, Germany, 20354
- Novartis Investigative Site
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Hannover, Germany, 30173
- Novartis Investigative Site
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Landsberg, Germany, 86899
- Novartis Investigative Site
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Leipzig, Germany, 04207
- Novartis Investigative Site
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Lubeck, Germany, 23552
- Novartis Investigative Site
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Mainz, Germany, 55131
- Novartis Investigative Site
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Marburg, Germany, D-35037
- Novartis Investigative Site
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Cegled, Hungary, 2700
- Novartis Investigative Site
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Godollo, Hungary, 2100
- Novartis Investigative Site
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Szarvas, Hungary, 5540
- Novartis Investigative Site
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Szeged, Hungary, 6722
- Novartis Investigative Site
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HUN
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Gyor, HUN, Hungary, 9024
- Novartis Investigative Site
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Szazhalombatta, HUN, Hungary, 2440
- Novartis Investigative Site
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Pest
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Torokbalint, Pest, Hungary, 2045
- Novartis Investigative Site
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Gujarat
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Ahmedabad, Gujarat, India, 380 060
- Novartis Investigative Site
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Vadodara, Gujarat, India, 390022
- Novartis Investigative Site
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Karnataka
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Bangalore, Karnataka, India, 560099
- Novartis Investigative Site
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Hubli, Karnataka, India, 580022
- Novartis Investigative Site
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Mysore, Karnataka, India, 570001
- Novartis Investigative Site
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Kerala
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Cherthala, Kerala, India, 688524
- Novartis Investigative Site
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Maharashtra
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Mumbai, Maharashtra, India, 401107
- Novartis Investigative Site
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Nagpur, Maharashtra, India
- Novartis Investigative Site
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Rajasthan
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Bikaner, Rajasthan, India, 334003
- Novartis Investigative Site
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Tamil Nadu
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Coimbatore, Tamil Nadu, India, 641 045
- Novartis Investigative Site
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Telangana
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Hyderabad, Telangana, India, 500018
- Novartis Investigative Site
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Uttar Pradesh
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Varanasi, Uttar Pradesh, India, 221005
- Novartis Investigative Site
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Genova, Italy, 16147
- Novartis Investigative Site
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Roma, Italy, 00161
- Novartis Investigative Site
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BA
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Cassano delle Murge, BA, Italy, 70020
- Novartis Investigative Site
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FI
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Firenze, FI, Italy, 50134
- Novartis Investigative Site
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RM
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Fiumicino, RM, Italy, 00054
- Novartis Investigative Site
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Tokyo
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Chuo ku, Tokyo, Japan, 103 0027
- Novartis Investigative Site
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Chuo-ku, Tokyo, Japan, 103-0027
- Novartis Investigative Site
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Setagaya-ku, Tokyo, Japan, 157006
- Novartis Investigative Site
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Shinjuku-ku, Tokyo, Japan, 162-0053
- Novartis Investigative Site
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Toshima-ku, Tokyo, Japan, 171-0014
- Novartis Investigative Site
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Busan, Korea, Republic of, 612-896
- Novartis Investigative Site
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Seoul, Korea, Republic of, 02841
- Novartis Investigative Site
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Gyeonggi Do
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Anyang si, Gyeonggi Do, Korea, Republic of, 14068
- Novartis Investigative Site
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Hwaseong si, Gyeonggi Do, Korea, Republic of, 18450
- Novartis Investigative Site
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Suwon si, Gyeonggi Do, Korea, Republic of, 16499
- Novartis Investigative Site
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Gyeonggi-Do
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Bucheon-Si, Gyeonggi-Do, Korea, Republic of, 14584
- Novartis Investigative Site
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Korea
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Seoul, Korea, Korea, Republic of, 03312
- Novartis Investigative Site
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Seocho Gu
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Seoul, Seocho Gu, Korea, Republic of, 06591
- Novartis Investigative Site
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Daugavpils, Latvia, LV-5417
- Novartis Investigative Site
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Riga, Latvia, LV 1002
- Novartis Investigative Site
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Riga, Latvia, LV-1001
- Novartis Investigative Site
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Riga, Latvia, LV-1004
- Novartis Investigative Site
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LV
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Riga, LV, Latvia, 1011
- Novartis Investigative Site
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LVA
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Jurmala, LVA, Latvia, LV-2015
- Novartis Investigative Site
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Vilnius, Lithuania, LT-08661
- Novartis Investigative Site
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Vilnius, Lithuania, 8109
- Novartis Investigative Site
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Putrajaya, Malaysia, 62250
- Novartis Investigative Site
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Kedah
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Alor Setar, Kedah, Malaysia, 05460
- Novartis Investigative Site
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Perak
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Taiping, Perak, Malaysia, 34000
- Novartis Investigative Site
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Terengganu
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Kuala Terengganu, Terengganu, Malaysia, 20400
- Novartis Investigative Site
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Cusco, Peru, 84
- Novartis Investigative Site
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Lima, Peru, 10
- Novartis Investigative Site
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Lima, Peru, 14
- Novartis Investigative Site
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Piura, Peru, 2000
- Novartis Investigative Site
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Lima
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Santiago de Surco, Lima, Peru, 33
- Novartis Investigative Site
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Manila, Philippines, 1008
- Novartis Investigative Site
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Quezon City, Philippines, 1100
- Novartis Investigative Site
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Iloilo
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Iloilo city, Iloilo, Philippines, 5000
- Novartis Investigative Site
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Bialystok, Poland, 15-044
- Novartis Investigative Site
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Biaystok, Poland, 15-430
- Novartis Investigative Site
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Grudziadz, Poland, 86-300
- Novartis Investigative Site
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Katowice, Poland, 40 085
- Novartis Investigative Site
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Ekaterinburg, Russian Federation, 620028
- Novartis Investigative Site
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Moscow, Russian Federation, 115478
- Novartis Investigative Site
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Rostov-on-Don, Russian Federation, 344011
- Novartis Investigative Site
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Saint-Petersburg, Russian Federation, 194044
- Novartis Investigative Site
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St Petersburg, Russian Federation, 191015
- Novartis Investigative Site
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St.Petersburg, Russian Federation, 196240
- Novartis Investigative Site
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Bratislava, Slovakia, 841 04
- Novartis Investigative Site
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Cadca, Slovakia, 022 01
- Novartis Investigative Site
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Presov, Slovakia, 080 01
- Novartis Investigative Site
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Sabinov, Slovakia, 08301
- Novartis Investigative Site
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Zvolen, Slovakia, 960 01
- Novartis Investigative Site
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SVK
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Banska Bystrica, SVK, Slovakia, 974 05
- Novartis Investigative Site
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Poprad, SVK, Slovakia, 058 01
- Novartis Investigative Site
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Slovak Republic
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Bardejov, Slovak Republic, Slovakia, 085 01
- Novartis Investigative Site
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Bojnice, Slovak Republic, Slovakia, 972 01
- Novartis Investigative Site
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Humenne, Slovak Republic, Slovakia, 066 01
- Novartis Investigative Site
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Liptovsky Hradok, Slovak Republic, Slovakia, 033 01
- Novartis Investigative Site
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Spisska Nova Ves, Slovak Republic, Slovakia, 052 01
- Novartis Investigative Site
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Stropkov, Slovak Republic, Slovakia, 09101
- Novartis Investigative Site
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Belleville, South Africa, 7530
- Novartis Investigative Site
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Cape Town, South Africa, 7531
- Novartis Investigative Site
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Panorama, South Africa, 7550
- Novartis Investigative Site
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Free State
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Brandfort, Free State, South Africa, 8340
- Novartis Investigative Site
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Mpumalanga
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Middelburg, Mpumalanga, South Africa, 1050
- Novartis Investigative Site
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ZAF
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Cape Town, ZAF, South Africa, 7570
- Novartis Investigative Site
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Stockholm, Sweden, 111 57
- Novartis Investigative Site
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Uppsala, Sweden, 75237
- Novartis Investigative Site
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Ostergotlands Lan
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Linkoping, Ostergotlands Lan, Sweden, 587 58
- Novartis Investigative Site
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Bangkok, Thailand, 10400
- Novartis Investigative Site
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Chiang Mai, Thailand, 50200
- Novartis Investigative Site
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THA
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Khon Kaen, THA, Thailand, 40002
- Novartis Investigative Site
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Hai Phong, Vietnam, 180000
- Novartis Investigative Site
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VNM
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Ho Chi Minh, VNM, Vietnam, 700000
- Novartis Investigative Site
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit
- Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit
- Adult patients who are symptomatic at screening despite treatment with existing therapy.
Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (inadequately controlled).
- Adolescent patients :
- If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 .
- If taking ICS (low dose)/ LABA, and have ACQ-7 score ≥1 and <1.5 at Visit 101: they must have ACQ-7 score≥1.5 at Visit 102 ( prior to randomization).
- Pre-bronchodilator FEV1≥ 60 % and < 90 % of the predicted normal value for the patient after withholding bronchodilators at both Visits 101 and 102
- Patients who demonstrate an increase in FEV1 of 12% and ≥ 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.
Exclusion Criteria:
- Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year.
- Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (> 24 hours) or emergency room visit (≤ 24 hours) as follows:
- For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation
- For adolescents: Severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR hospitalization (> 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR emergency room visit (≤ 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids within the last 6 months.
- Patients who ever required intubation for a severe asthma attack/exacerbation
- Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment )
- Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
- Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study.
- Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
- Patients with Type I diabetes or uncontrolled Type II diabetes.
- Patients with narcolepsy and/or insomnia.
- Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.
- Patients who use a long acting muscarinic antagonist (LAMA) within 3 months prior to Visit 1.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Experimental: QMF149 150/80 μg
QMF149 150/80 microgram o.d.
delivered via Concept1
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QMF149 150/80 μg o.d via Concept1
Other Names:
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Active Comparator: MF 200 µg
MF 200 microgram o.d.
delivered via Twisthaler®
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MF 200 μg o.d. via Twisthaler®
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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Trough FEV1
Time Frame: week 12
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demonstrate the superiority of QMF149 150/80 microgram o.d.
(in the evening) delivered via Concept1 compared with MF 200 microgram o.d.
(in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents.
Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
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week 12
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
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ACQ-7
Time Frame: week 12
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ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control.
the ACQ-7 was used to assess improvements in asthma symptom control.
The ACQ-7, a seven-item disease-specific instrument developed and validated to assess asthma control in patients in clinical trials as well as in individuals in clinical practice, was provided to the site.
All seven items were then scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating no control.
The questions were equally weighted and the total score was the mean of the seven items.
The first 6 questions of the ACQ-7 were completed by the patient while the last question (question 7) was completed by the study investigator using spirometry data generated by the spirometry equipment.
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week 12
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Trough FEV1 at Day 2
Time Frame: Day 2
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Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing
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Day 2
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Pre-dose FEV1 at Week 4
Time Frame: week 4
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Pre-dose FEV1 is defined as the mean of -45 min and -15 min FEV1 values pre-evening dose
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week 4
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FVC Over 12 Weeks
Time Frame: week 12
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FVC is the total amount of air exhaled during the FEV test.
Forced Vital Capacity (FVC) and Forced Expiratory Flow between 25% and 75% of FVC (FEF25-75) will be measured
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week 12
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PEF Over 4 and 12 Weeks
Time Frame: week 12
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Morning and Evening Peak Expiratory Flow Rate (PEF) will be measured.
PEF is the peak expiratory flow, the maximum speed of expiration
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week 12
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Percentage of Patients With ACQ-7 MID at Week 12
Time Frame: week 12
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MID is Minimum Important Difference.
ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control.
Percent of patients achieving the minimal important difference (MID) in ACQ-7 (i.e. at least 0.5 decrease from baseline) will be measured.
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week 12
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Daily E-diary Over 12 Weeks
Time Frame: week 12
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Percentage of asthma symptoms free days, the percentage of nights without nighttime awakenings, and the percentage of mornings without symptoms on awakening as recorded by daily electronic Diary (e-Diary) over 12 weeks of treatment
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week 12
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ACQ-7 at Week 4
Time Frame: week 4
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ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control
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week 4
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Rescue Medication Use Over 12 Weeks
Time Frame: week 12
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Rescue salbutamol/albuterol usage (mean daily, nighttime and daytime use) from e-Diary recordings over 12 weeks of treatment
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week 12
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Percentage of Rescue Medication Free Days Over 12 Weeks
Time Frame: week 12
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Percentage of rescue medication free days over 12 weeks of treatment period
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week 12
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Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12
Time Frame: week 12
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The AQLQ is a 32-item disease specific questionnaire designed to measure functional impairments in asthma.
Patients are asked to score each item on a 7-point scale based on the experience of last 2 weeks.
The overall AQLQ score is the mean response to all 32 questions.
Therefore, the possible highest score (better) would be 7 and the lowest (worse) would be 1.
Changes in scores of 0.5 to 1.0 are considered clinically meaningful; 1.0 to 1.5 as moderate and > 1.5 as marked clinically important differences for any individual domain or for the overall summary score.
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week 12
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Number of Patients With Asthma Exacerbation Over 12 Weeks
Time Frame: Week 12
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The exacerbation categories are: mild, moderate, severe and the combination of moderate or severe.
Time to first asthma exacerbation by exacerbation category.
Annual rate of asthma exacerbations by exacerbation category.
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Week 12
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The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
Time Frame: Week 12
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Annual incidence rate of asthma exacerbation by severity of exacerbation.
The number of asthma exacerbation is used to calculate annual incidence rate.
A severe asthma exacerbation is SCS (Systemic Corticosteroids) use ≥3 days and hospitalization or emergency department visit (greater than 24 h) or death due to asthma.
A moderate asthma exacerbation is SCS use ≥3 days either as an outpatient or in emergency department visits (less than or equal to 24 h).
Worsening of asthma not requiring more than 3 days of SCS or hospitalization/emergency room will be considered mild asthma exacerbations
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Week 12
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Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
Time Frame: Week 12
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The annual rate of asthma exacerbations were analyzed using a generalized linear model.
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Week 12
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Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CQVM149B2303
- 2016-000472-22 (EudraCT Number)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Novartis is committed to sharing with qualified external researchers, access to patient-level data and supporting clinical documents from eligible studies. These requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations.
This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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