Clinical trial NCT02892344: Study of QMF149 (150/80 µg) Compared With MF Twisthaler® (200 µg) in Patients With Asthma
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Mild Asthma
Keywords: Phase III, blinded, QMF149, Mometasone furoate (MF), mild asthma, Adolescent, adult
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2016-09-08
Enrollment: 802
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 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.

Detailed description: The primary objective of this study was to 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. The key secondary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks of treatment.

Eligibility criteria: 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.

Primary outcomes:
measure: Trough FEV1
timeFrame: week 12
Secondary outcomes:
measure: ACQ-7
timeFrame: week 12
measure: Trough FEV1 at Day 2
timeFrame: Day 2
measure: Pre-dose FEV1 at Week 4
timeFrame: week 4
measure: FVC Over 12 Weeks
timeFrame: week 12
measure: PEF Over 4 and 12 Weeks
timeFrame: week 12
measure: Percentage of Patients With ACQ-7 MID at Week 12
timeFrame: week 12
measure: Daily E-diary Over 12 Weeks
timeFrame: week 12
measure: ACQ-7 at Week 4
timeFrame: week 4
measure: Rescue Medication Use Over 12 Weeks
timeFrame: week 12
measure: Percentage of Rescue Medication Free Days Over 12 Weeks
timeFrame: week 12
measure: Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12
timeFrame: week 12
measure: Number of Patients With Asthma Exacerbation Over 12 Weeks
timeFrame: Week 12
measure: The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
timeFrame: Week 12
measure: Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period
timeFrame: Week 12
Other outcomes:
Locations:
city: Bulgaria
country: Bulgaria
facility: Novartis Investigative Site
city: Pleven
country: Bulgaria
facility: Novartis Investigative Site
city: Stara Zagora
country: Bulgaria
facility: Novartis Investigative Site
city: Santiago
country: Chile
facility: Novartis Investigative Site
state: Region Metropolitana
city: Santiago
country: Chile
facility: Novartis Investigative Site
city: Santiago
country: Chile
facility: Novartis Investigative Site
city: Vina del Mar
country: Chile
facility: Novartis Investigative Site
city: Medellin
country: Colombia
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state: Antioquia
city: Bogota
country: Colombia
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state: Cundinamarca
city: Bogota
country: Colombia
facility: Novartis Investigative Site
city: Bucaramanga
country: Colombia
facility: Novartis Investigative Site
city: Medellin
country: Colombia
facility: Novartis Investigative Site
city: Kohtla-Jarve
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Bad Woerishofen
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Bochum
country: Germany
facility: Novartis Investigative Site
city: Darmstadt
country: Germany
facility: Novartis Investigative Site
city: Frankfurt
country: Germany
facility: Novartis Investigative Site
city: Gauting
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Landsberg
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Lubeck
country: Germany
facility: Novartis Investigative Site
city: Mainz
country: Germany
facility: Novartis Investigative Site
city: Marburg
country: Germany
facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Szazhalombatta
country: Hungary
facility: Novartis Investigative Site
state: HUN
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
state: Pest
city: Cegled
country: Hungary
facility: Novartis Investigative Site
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city: Szarvas
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facility: Novartis Investigative Site
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city: Vadodara
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city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Hubli
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city: Mysore
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state: Karnataka
city: Cherthala
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state: Kerala
city: Mumbai
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state: Maharashtra
city: Nagpur
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city: Bikaner
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state: Rajasthan
city: Coimbatore
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city: Hyderabad
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city: Varanasi
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state: Uttar Pradesh
city: Cassano delle Murge
country: Italy
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state: BA
city: Firenze
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state: FI
city: Fiumicino
country: Italy
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state: RM
city: Genova
country: Italy
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city: Roma
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city: Chuo ku
country: Japan
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state: Tokyo
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facility: Novartis Investigative Site
state: Tokyo
city: Setagaya-ku
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state: Tokyo
city: Shinjuku-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
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state: Tokyo
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state: Gyeonggi Do
city: Hwaseong si
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state: Gyeonggi Do
city: Suwon si
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: Seocho Gu
city: Busan
country: Korea, Republic of
facility: Novartis Investigative Site
city: Seoul
country: Korea, Republic of
facility: Novartis Investigative Site
city: Jurmala
country: Latvia
facility: Novartis Investigative Site
state: LVA
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: Riga
country: Latvia
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Alor Setar
country: Malaysia
facility: Novartis Investigative Site
state: Kedah
city: Taiping
country: Malaysia
facility: Novartis Investigative Site
state: Perak
city: Kuala Terengganu
country: Malaysia
facility: Novartis Investigative Site
state: Terengganu
city: Putrajaya
country: Malaysia
facility: Novartis Investigative Site
city: Santiago de Surco
country: Peru
facility: Novartis Investigative Site
state: Lima
city: Cusco
country: Peru
facility: Novartis Investigative Site
city: Lima
country: Peru
facility: Novartis Investigative Site
city: Lima
country: Peru
facility: Novartis Investigative Site
city: Piura
country: Peru
facility: Novartis Investigative Site
city: Iloilo city
country: Philippines
facility: Novartis Investigative Site
state: Iloilo
city: Manila
country: Philippines
facility: Novartis Investigative Site
city: Quezon City
country: Philippines
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Biaystok
country: Poland
facility: Novartis Investigative Site
city: Grudziadz
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
city: Rostov-on-Don
country: Russian Federation
facility: Novartis Investigative Site
city: Saint-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: Bardejov
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bojnice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Humenne
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Liptovsky Hradok
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: Banska Bystrica
country: Slovakia
facility: Novartis Investigative Site
state: SVK
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
state: SVK
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Cadca
country: Slovakia
facility: Novartis Investigative Site
city: Presov
country: Slovakia
facility: Novartis Investigative Site
city: Sabinov
country: Slovakia
facility: Novartis Investigative Site
city: Zvolen
country: Slovakia
facility: Novartis Investigative Site
city: Brandfort
country: South Africa
facility: Novartis Investigative Site
state: Free State
city: Middelburg
country: South Africa
facility: Novartis Investigative Site
state: Mpumalanga
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
state: ZAF
city: Belleville
country: South Africa
facility: Novartis Investigative Site
city: Cape Town
country: South Africa
facility: Novartis Investigative Site
city: Panorama
country: South Africa
facility: Novartis Investigative Site
city: Linkoping
country: Sweden
facility: Novartis Investigative Site
state: Ostergotlands Lan
city: Stockholm
country: Sweden
facility: Novartis Investigative Site
city: Uppsala
country: Sweden
facility: Novartis Investigative Site
city: Khon Kaen
country: Thailand
facility: Novartis Investigative Site
state: THA
city: Bangkok
country: Thailand
facility: Novartis Investigative Site
city: Chiang Mai
country: Thailand
facility: Novartis Investigative Site
city: Ho Chi Minh
country: Vietnam
facility: Novartis Investigative Site
state: VNM
city: Hai Phong
country: Vietnam
facility: Novartis Investigative Site
Study officials:
References: