Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma

NCT02892344 | Completed Phase 3 Results DMC

• 2 other identifiers: CQVM149B23032016-000472-22
• Study Type: interventional
• Target: 802
• Locations: 22 countries
• Sites: 123

Brief Summary

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.

Conditions

Mild Asthma

Keywords

Phase III, blinded, QMF149, Mometasone furoate (MF), mild asthma, Adolescent, adult

Outcome Measures

Primary Outcomes (1)

• Trough FEV1

  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.

  week 12

Secondary Outcomes (14)

• ACQ-7

  week 12

• Trough FEV1 at Day 2

  Day 2

• Pre-dose FEV1 at Week 4

  week 4

• FVC Over 12 Weeks

  week 12

• PEF Over 4 and 12 Weeks

  week 12

Study Arms (2)

QMF149 150/80 μg

EXPERIMENTAL

QMF149 150/80 microgram o.d. delivered via Concept1

Drug: QMF149 150/80 μg

MF 200 µg

ACTIVE COMPARATOR

MF 200 microgram o.d. delivered via Twisthaler®

Drug: MF 200 μg

Interventions

QMF149 150/80 μg DRUG

QMF149 150/80 μg o.d via Concept1

Also known as: Indacaterol acetate/Mometasone furoate

QMF149 150/80 μg

MF 200 μg DRUG

MF 200 μg o.d. via Twisthaler®

Also known as: Mometasone furoate

MF 200 µg

Eligibility Criteria

• Age: 12 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (123)

Novartis Investigative Site

Bulgaria, Bulgaria, Bulgaria

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Novartis Investigative Site

Stara Zagora, Bulgaria, 6000, Bulgaria

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Novartis Investigative Site

Pleven, 5800, Bulgaria

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Novartis Investigative Site

Santiago, Santiago Metropolitan, 7500692, Chile

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Santiago, 8380453, Chile

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Santiago, Chile

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Viña del Mar, 2520594, Chile

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Medellín, Antioquia, 0050010, Colombia

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Bucaramanga, Colombia, Colombia

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Medellín, Colombia, Colombia

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Bogota, Cundinamarca, 110911, Colombia

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Bogotá, Colombia

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Novartis Investigative Site

Tartu, Estonia, 51014, Estonia

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Kohtla-Järve, 30322, Estonia

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Tallinn, 13419, Estonia

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Tartu, 51014, Estonia

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Bochum, Germany, 44791, Germany

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Marburg, Germany, D-35037, Germany

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Bad Wörishofen, 86825, Germany

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Berlin, 10119, Germany

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Darmstadt, 64283, Germany

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Frankfurt, 60596, Germany

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Gauting, 82131, Germany

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Hamburg, 20354, Germany

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Hanover, 30173, Germany

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Landsberg, 86899, Germany

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Leipzig, 04207, Germany

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Lübeck, 23552, Germany

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Mainz, 55131, Germany

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Szarvas, Hungary, 5540, Hungary

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Szeged, Hungary, 6722, Hungary

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Győr, HUN, 9024, Hungary

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Százhalombatta, HUN, 2440, Hungary

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Törökbálint, Pest County, 2045, Hungary

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Cegléd, 2700, Hungary

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Gödöllő, 2100, Hungary

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Ahmedabad, Gujarat, 380 060, India

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Vadodara, Gujarat, 390022, India

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Bangalore, Karnataka, 560099, India

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Hubli, Karnataka, 580022, India

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Mysore, Karnataka, 570001, India

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Cherthala, Kerala, 688524, India

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Mumbai, Maharashtra, 401107, India

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Nagpur, Maharashtra, India

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Bikaner, Rajasthan, 334003, India

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Coimbatore, Tamil Nadu, 641 045, India

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Hyderabad, Telangana, 500018, India

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Varanasi, Uttar Pradesh, 221005, India

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Cassano delle Murge, BA, 70020, Italy

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Florence, FI, 50134, Italy

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Genova, Italy, 16147, Italy

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Fiumicino, RM, 00054, Italy

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Roma, 00161, Italy

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Chuo Ku, Tokyo, 103 0027, Japan

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Chuo-ku, Tokyo, 103-0027, Japan

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Setagaya-ku, Tokyo, 157006, Japan

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Shinjuku-ku, Tokyo, 162-0053, Japan

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Toshima-ku, Tokyo, 171-0014, Japan

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Jūrmala, LVA, LV-2015, Latvia

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Riga, LV, 1011, Latvia

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Daugavpils, LV-5417, Latvia

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Riga, LV 1002, Latvia

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Riga, LV-1001, Latvia

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Riga, LV-1004, Latvia

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Vilnius, 8109, Lithuania

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Vilnius, LT-08661, Lithuania

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Alor Star, Kedah, 05460, Malaysia

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Taiping, Perak, 34000, Malaysia

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Kuala Terengganu, Terengganu, 20400, Malaysia

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Putrajaya, 62250, Malaysia

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Santiago de Surco, Lima region, 33, Peru

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Cusco, 84, Peru

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Lima, 10, Peru

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Lima, 14, Peru

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Piura, 2000, Peru

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Iloilo City, Iloilo, 5000, Philippines

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Manila, 1008, Philippines

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Quezon City, 1100, Philippines

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Biaystok, Poland, 15-430, Poland

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Bialystok, 15-044, Poland

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Grudziądz, 86-300, Poland

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Katowice, 40 085, Poland

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Moscow, 115478, Russia

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Rostov-on-Don, 344011, Russia

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Saint Petersburg, 191015, Russia

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Saint Petersburg, 194044, Russia

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Saint Petersburg, 196240, Russia

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Yekaterinburg, 620028, Russia

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Bardejov, Slovak Republic, 085 01, Slovakia

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Bojnice, Slovak Republic, 972 01, Slovakia

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Humenné, Slovak Republic, 066 01, Slovakia

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Liptovský Hrádok, Slovak Republic, 033 01, Slovakia

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Spišská Nová Ves, Slovak Republic, 052 01, Slovakia

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Stropkov, Slovak Republic, 09101, Slovakia

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Čadca, Slovakia, 022 01, Slovakia

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Prešov, Slovakia, 080 01, Slovakia

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Zvolen, Slovakia, 960 01, Slovakia

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Banská Bystrica, SVK, 974 05, Slovakia

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Poprad, SVK, 058 01, Slovakia

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Bratislava, 841 04, Slovakia

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Sabinov, 08301, Slovakia

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Winnie Mandela, Free State, 8340, South Africa

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Middelburg, Mpumalanga, 1050, South Africa

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Belleville, South Africa, 7530, South Africa

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Cape Town, ZAF, 7570, South Africa

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Cape Town, 7531, South Africa

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Panorama, 7550, South Africa

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Anyang-si, Gyeonggi-do, 14068, South Korea

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Bucheon-si, Gyeonggi-do, 14584, South Korea

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Hwaseong-si, Gyeonggi-do, 18450, South Korea

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Suwon, Gyeonggi-do, 16499, South Korea

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Seoul, Korea, 03312, South Korea

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Seoul, Seocho gu, 06591, South Korea

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Busan, 612-896, South Korea

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Seoul, 02841, South Korea

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Stockholm, 111 57, Sweden

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Uppsala, 75237, Sweden

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Linköping, Östergötland County, 587 58, Sweden

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Bangkok, Thailand, 10400, Thailand

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Khon Kaen, THA, 40002, Thailand

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Chiang Mai, 50200, Thailand

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Ho Chi Minh City, VNM, 700000, Vietnam

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Novartis Investigative Site

Haiphong, 180000, Vietnam

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Related Publications (1)

• Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

  PMID: 36472162 DERIVED

Related Links

• A Plain Language Trial Summary is available on novartisclinicaltrials.com
• A Pediatric Plain Language Trial Summary is available on novartisclinicaltrials.com

MeSH Terms

Interventions

QMF149; indacaterol; Mometasone Furoate

Intervention Hierarchy (Ancestors)

Pregnadienediols; Pregnadienes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Results Point of Contact

• Title: Study Director
• Organization: Novartis Pharmaceuticals

novartis.email@novartis.com

862-778-8300

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 29, 2016
• First Posted: September 8, 2016
• Study Start: January 16, 2017
• Primary Completion: November 5, 2018
• Study Completion: November 30, 2018
• Last Updated: January 13, 2026
• Results First Posted: September 12, 2019

Record last verified: 2025-12

Locations

JP (5); MY (4); VN (2); IT (5); PL (4); RU (6); ZA (6); LA (6); TH (3); HU (7); PE (5); PH (3); BU (3); ES (4); CL (4); KR (8); IN (12); DE (13); SL (13); CO (5); LI (2); SE (3)