Clinical trial NCT02554786: A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Participants With Asthma
Official title: A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: QMF149, Mometasone furoate (MF), asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2015-09-18
Enrollment: 2216
Sex: ALL
Minimum age (years): 12
Maximum age (years): 75
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic participants as determined by pulmonary function testing, and effects on asthma control


Eligibility criteria: Inclusion Criteria:

* Participants with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening)
* Participants who have used medium or high dose inhaled corticosteroids (ICS) or low dose of long acting beta-2 agonist (LABA)/ICS combinations for asthma for at least 3 months and at stable doses for at least 1 month prior to Visit 1
* Participants must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS
* Pre-bronchodilator ≥ 50% Forced expiratory volume in 1 second (FEV1) of \< 85 % of the predicted normal value for the participants after withholding bronchodilators at both Visit 101 and 102, according to American Thoracic Society/European Respiratory Society (ATS/ERS) criteria.
* Withholding period of bronchodilators prior to spirometry: short acting beta-2 agonist (SABA) for ≥ 6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, short acting anticholinergics (SAMA) for ≥ 8 hours, xanthines \>=07 days
* A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is allowed at Visit 101 and at Visit 102.

Spacer devices are permitted for reversibility testing only.

-Participants who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101 All participants must perform a reversibility test at Visit 101

If reversibility is not demonstrated at Visit 101:

* Reversibility should be repeated once-
* Participants may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1
* Alternatively, participants may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1.

Exclusion Criteria:

* Participants who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. This includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1
* Participants who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)
* Participants who have ever required intubation for a severe asthma attack/exacerbation.
* Participants who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study).
* Participants who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Participants may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
* Participants with a history of chronic lung diseases other than asthma, including (but not limited to) Chronic Obstructive Pulmonary Disease (COPD), sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
* Participants with severe narcolepsy and/or insomnia.
* Participants who have a clinically significant electrocardiogram (ECG) abnormality at Visit 101 (Start of Run- In epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via central reader) should be clinically assessed by the investigator with supportivedocumentation
* Participants with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof
* Participants who have not achieved an acceptable spirometry results at Visit 101 in accordance with ATS/ERS criteria for acceptability and repeatability (rescreening allowed only once).

Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify due to ATS/ERS criteria. If the participant fails the repeat assessment, the participant may be rescreened once

* Participants on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or participants on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
* Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 30 days after stopping of study treatment.
* Long acting muscarinic antagonist (LAMA) use within 3 months prior to Visit 101

Primary outcomes:
measure: Trough Forced Expiratory Volume in One Second (Trough FEV1) at Week 26
timeFrame: 26 weeks
Secondary outcomes:
measure: Asthma Control Questionnaire (ACQ-7) at Weeks 4, 12, 26 and 52
timeFrame: Weeks 4, 12, 26 and 52
measure: Trough FEV1 at Week 52
timeFrame: Week 52
measure: Pre-dose FEV1 at Weeks 4 and 12
timeFrame: Weeks 4 (Day 30) and 12 (Day 86)
measure: Post Dose FEV1 (5 Minutes-1 Hour)
timeFrame: Up to Week 52 (Day 364)
measure: Trough Forced Vital Capacity (FVC)
timeFrame: Up to Week 52 (Day 365)
measure: Trough Forced Expiratory Flow (FEF)Between 25% and 75% of FVC (FEF25-75)
timeFrame: Up to Week 52 (Day 365)
measure: Change From Baseline in Morning and Evening Peak Expiratory Flow Rate (PEF) Over 26 and 52 Weeks of Treatment
timeFrame: Up to Weeks 26 and 52
measure: Percentage of Participants Achieving the Minimal Important Difference (MID) ACQ ≥ 0.5 at Weeks 26 and 52
timeFrame: Weeks 26 (Day 183) and 52 (Day 364)
measure: Change From Baseline in Percentage of Asthma Symptoms Free Days
timeFrame: Up to Week 52
measure: Change Form Baseline in Percentage of Days With no Daytime Symptoms
timeFrame: Up to Week 52
measure: Change From Baseline in Percentage of Nights With no Night-time Awakenings
timeFrame: Up to Week 52
measure: Change Form Baseline in Percentage of Mornings With no Symptoms on Awakening
timeFrame: Up to Week 52
measure: Rescue Medication Usage
timeFrame: Up to Weeks 26 and 52
measure: Time to First Asthma Exacerbation by Exacerbation Category
timeFrame: Up to Week 52
measure: Time to First Hospitalization for Asthma Exacerbation
timeFrame: Up to Week 52
measure: Annual Rate of Asthma Exacerbations by Exacerbation Category
timeFrame: Up to Week 52
measure: Duration in Days of Asthma Exacerbations by Exacerbation Category
timeFrame: Up to Week 52
measure: Percentage of Participants With at Least One Asthma Exacerbation by Exacerbation Category
timeFrame: Up to Week 52
measure: Time in Days to Permanent Discontinuation of Study Medication Due to Asthma Exacerbations
timeFrame: Up to Week 52
measure: Percentage of Participants Who Permanently Discontinued Study Medication Due to Asthma Exacerbations
timeFrame: Up to Week 52
measure: Total Amounts of Systemic Corticosteroids (in Doses) Used to Treat Asthma Exacerbations
timeFrame: Up to Week 52
measure: Change From Baseline in Percentage of Rescue Medication Free Days
timeFrame: Up to Weeks 26 and 52
measure: Asthma Quality of Life Questionnaire (AQLQ)
timeFrame: Up to Week 52 (Day 364)
measure: Trough FEV1 Measured After 26 Weeks of Treatment
timeFrame: Week 26
measure: Percentage of Participants With Composite Endpoint of Serious Asthma Outcomes
timeFrame: Up to Week 52
measure: Percentage of Participants With Adverse Events (AE) and Serious Adverse Events (SAE)
timeFrame: Approximately up to 56 weeks
Other outcomes:
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city: Osaka city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Takatsuki-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Toyonaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Yao-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Koshigaya-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Tokyo
country: Japan
facility: Novartis Investigative Site
state: Shibuya Ku
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuou-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Itabashi-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Setagaya-Ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Cheongju si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Chungcheongbuk Do
city: Wonju
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gangwon-do
city: Bundang Gu
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi Do
city: Bucheon-Si
country: Korea, Republic of
facility: Novartis Investigative Site
state: Gyeonggi-Do
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Korea
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
state: Seocho Gu
city: Incheon
country: Korea, Republic of
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Daugavpils
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Riga
country: Latvia
facility: Novartis Investigative Site
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LTU
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Siauliai
country: Lithuania
facility: Novartis Investigative Site
city: Utena
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Mexicali
country: Mexico
facility: Novartis Investigative Site
state: Baja California
city: Ciudad de Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Novartis Investigative Site
state: Distrito Federal
city: Mexico
country: Mexico
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
state: POL
city: Wejherowo
country: Poland
facility: Novartis Investigative Site
state: POL
city: Aleksandrow Odzki
country: Poland
facility: Novartis Investigative Site
city: Biaystok
country: Poland
facility: Novartis Investigative Site
city: Bielsko-Biala
country: Poland
facility: Novartis Investigative Site
city: Elblag
country: Poland
facility: Novartis Investigative Site
city: Inowroclaw
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Ostrow Wielkopolski
country: Poland
facility: Novartis Investigative Site
city: Sopot
country: Poland
facility: Novartis Investigative Site
city: Warsaw
country: Poland
facility: Novartis Investigative Site
city: Zawadzkie
country: Poland
facility: Novartis Investigative Site
city: Iasi
country: Romania
facility: Novartis Investigative Site
state: Jud Iasi
city: Constanta
country: Romania
facility: Novartis Investigative Site
state: Jud. Constanta
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: Jud.Dolj
city: Bucharest
country: Romania
facility: Novartis Investigative Site
state: ROM
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: ROM
city: Craiova
country: Romania
facility: Novartis Investigative Site
state: ROM
city: Deva
country: Romania
facility: Novartis Investigative Site
state: ROM
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: ROM
city: Timisoara
country: Romania
facility: Novartis Investigative Site
state: Timis
city: Arad
country: Romania
facility: Novartis Investigative Site
city: Bacau
country: Romania
facility: Novartis Investigative Site
city: Bragadiru
country: Romania
facility: Novartis Investigative Site
city: Braila
country: Romania
facility: Novartis Investigative Site
city: Brasov
country: Romania
facility: Novartis Investigative Site
city: Bucharest
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Bucuresti
country: Romania
facility: Novartis Investigative Site
city: Cluj Napoca
country: Romania
facility: Novartis Investigative Site
city: Cluj Napoca
country: Romania
facility: Novartis Investigative Site
city: Cluj-Napoca
country: Romania
facility: Novartis Investigative Site
city: Codlea
country: Romania
facility: Novartis Investigative Site
city: Craiova
country: Romania
facility: Novartis Investigative Site
city: Ramnicu Valcea
country: Romania
facility: Novartis Investigative Site
city: Suceava
country: Romania
facility: Novartis Investigative Site
city: Targu Mures
country: Romania
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Chelyabinsk
country: Russian Federation
facility: Novartis Investigative Site
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
city: Krasnoyarsk
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: N.Novgorod
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Novosibirsk
country: Russian Federation
facility: Novartis Investigative Site
city: Penza
country: Russian Federation
facility: Novartis Investigative Site
city: Petrozavodsk
country: Russian Federation
facility: Novartis Investigative Site
city: Pyatigorsk
country: Russian Federation
facility: Novartis Investigative Site
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
city: Ryazan
country: Russian Federation
facility: Novartis Investigative Site
city: Saint Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Saratov
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: Smolensk
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St-Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: St.Petersburg
country: Russian Federation
facility: Novartis Investigative Site
city: Stavropol
country: Russian Federation
facility: Novartis Investigative Site
city: Volgograd
country: Russian Federation
facility: Novartis Investigative Site
city: Vologodonsk
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Yekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Belgrade
country: Serbia
facility: Novartis Investigative Site
city: Beograd
country: Serbia
facility: Novartis Investigative Site
city: Kragujevac
country: Serbia
facility: Novartis Investigative Site
city: Nis
country: Serbia
facility: Novartis Investigative Site
city: Sremska Kamenica
country: Serbia
facility: Novartis Investigative Site
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bojnice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Humenne
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Skalica
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Spisska Nova Ves
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Stropkov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Surany
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Velky Meder
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Námestovo
country: Slovakia
facility: Novartis Investigative Site
state: Slovensko
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
state: SVK
city: Bardejov
country: Slovakia
facility: Novartis Investigative Site
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Cadca
country: Slovakia
facility: Novartis Investigative Site
city: Ilava
country: Slovakia
facility: Novartis Investigative Site
city: Komarno
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
city: Kralovsky Chlmec
country: Slovakia
facility: Novartis Investigative Site
city: Levice
country: Slovakia
facility: Novartis Investigative Site
city: Liptovsky Mikulas
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Prievidza
country: Slovakia
facility: Novartis Investigative Site
city: Topolcany
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Zilina
country: Slovakia
facility: Novartis Investigative Site
city: Berea
country: South Africa
facility: Novartis Investigative Site
state: Durban
city: Panorama
country: South Africa
facility: Novartis Investigative Site
state: Western Cape
city: Belleville
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Fowey
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Liskeard
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Torpoint
country: United Kingdom
facility: Novartis Investigative Site
state: Cornwall
city: Faringdon
country: United Kingdom
facility: Novartis Investigative Site
state: Oxfordshire
city: Bristol
country: United Kingdom
facility: Novartis Investigative Site
state: South Gloucestershire
city: Blackpool
country: United Kingdom
facility: Novartis Investigative Site
city: Denbighshire
country: United Kingdom
facility: Novartis Investigative Site
city: Glasgow
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: London
country: United Kingdom
facility: Novartis Investigative Site
city: Rotherham
country: United Kingdom
facility: Novartis Investigative Site
city: Wiltshire
country: United Kingdom
facility: Novartis Investigative Site
Study officials:
References:
citation: Chapman K, van Zyl-Smit R, Maspero J, Kerstjens HAM, Gon Y, Hosoe M, Tanase AM, Pethe A, Shu X, D'Andrea P. One time a day mometasone/indacaterol fixed-dose combination versus two times a day fluticasone/salmeterol in patients with inadequately controlled asthma: pooled analysis from PALLADIUM and IRIDIUM studies. BMJ Open Respir Res. 2021 Aug;8(1):e000819. doi: 10.1136/bmjresp-2020-000819.
citation: van Zyl-Smit RN, Krull M, Gessner C, Gon Y, Noga O, Richard A, de Los Reyes A, Shu X, Pethe A, Tanase AM, D'Andrea P; PALLADIUM trial investigators. Once-daily mometasone plus indacaterol versus mometasone or twice-daily fluticasone plus salmeterol in patients with inadequately controlled asthma (PALLADIUM): a randomised, double-blind, triple-dummy, controlled phase 3 study. Lancet Respir Med. 2020 Oct;8(10):987-999. doi: 10.1016/S2213-2600(20)30178-8. Epub 2020 Jul 9.