Clinical trial NCT01555151: Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma
Official title: A Randomized, Double-blind, Double-dummy, 4-week Treatment, Parallel-group Study to Evaluate the Efficacy and Safety of Two Doses of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Asthma
Keywords: Asthma
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2012-03-15
Enrollment: 739
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to compare the efficacy, safety and pharmacokinetics of Mometasone furoate delivered via Concept1 device or Twisthaler® device in adult and adolescent patients with persistent asthma.


Eligibility criteria: Inclusion Criteria:

* Males or females who were ≥ 12 years old at the time informed consent was obtained
* Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally met the following criteria
* Patients who were receiving ICS treatment up to the maximum dose per day as indicated in the corresponding package leaflet and also a stable ICS regimen for at least 4 weeks prior to screening (Visit 2).
* Patients whose level of asthma control according to GINA 2010 guideline was "Partly Controlled" or "Uncontrolled" at screening (Visit 2).
* Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value at screening (Visit 2).
* Patients who demonstrated an increase of ≥ 12% and 200 mL in FEV1 over prebronchodilator value within 30 minutes after inhalation of 400 μg of salbutamol (360 μg of albuterol) at Visit 2 or between Visit 2 and Visit 5.
* Patients who were confirmed as "ICS sensitive" by ACQ-5 and FEV1 at Visit 5.

Key exclusion criteria included:

* Patients diagnosed with COPD as defined by the Global Initiative for Chronic Obstructive Lung Disease, updated 2010.
* Patients with concomitant pulmonary disease, pulmonary tuberculosis (unless confirmed by chest X-ray to be no longer active), or clinically significant bronchiectasis.
* Patients with any chronic conditions affecting the respiratory tract (e.g., chronic sinusitis) or chronic lung diseases, which in the opinion of the investigator may interfere with the study evaluation or optimal participation in the study.
* Patients with seasonal allergy which is likely to deteriorate his/her asthma condition during the study period judged by the investigator.
* Patients who have had a severe asthma attack/exacerbation requiring hospitalization in the 6 months prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).
* Patients who have had an emergency room visit for an asthma attack/exacerbation within 4 weeks prior to Visit 1 or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).
* Patients who have ever required intubation for a severe asthma attack/exacerbation.
* Patients who have had a respiratory tract infection within 6 weeks prior to Visit 1, or any time between Visit 1 and Visit 5 must discontinue from the trial (screening failure).

Other protocol-defined inclusion/exclusion criteria may apply

Primary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1)
timeFrame: Day 29
Secondary outcomes:
measure: Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment
timeFrame: Days 8, 15 and 22
measure: Forced Vital Capacity (FVC) at All Time Points
timeFrame: Days 1, 8, 15, 22, 28 and 29 at all time points
measure: Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points
timeFrame: Days 1, 8, 15, 22, 28 and 29 at all time points
measure: Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points
timeFrame: Days 1, 8, 15, 22, 28 and 29 at all time points
measure: Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment
timeFrame: Baseline and week 4
measure: Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit
timeFrame: Baseline, days 8,15,22 and 29
measure: Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment
timeFrame: Baseline and 4 weeks
measure: Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment
timeFrame: 4 weeks
measure: Fractional Exhaled Nitric Oxide (FeNO)
timeFrame: Days 15 and 29
measure: Plasma Cortisol Concentrations
timeFrame: Baseline, days 1 and 28
Other outcomes:
Locations:
city: Kortrijk
country: Belgium
facility: Novartis Investigative Site
city: Liège
country: Belgium
facility: Novartis Investigative Site
city: Niagara Falls
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Windsor
country: Canada
facility: Novartis Investigative Site
state: Ontario
city: Mirabel
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Montreal
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Trois-Rivières
country: Canada
facility: Novartis Investigative Site
state: Quebec
city: Quebec
country: Canada
facility: Novartis Investigative Site
city: Kohtla-Järve
country: Estonia
facility: Novartis Investigative Site
city: Tallinn
country: Estonia
facility: Novartis Investigative Site
city: Tartu
country: Estonia
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Berlin
country: Germany
facility: Novartis Investigative Site
city: Dresden
country: Germany
facility: Novartis Investigative Site
city: Essen
country: Germany
facility: Novartis Investigative Site
city: Goch
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hamburg
country: Germany
facility: Novartis Investigative Site
city: Hannover
country: Germany
facility: Novartis Investigative Site
city: Leipzig
country: Germany
facility: Novartis Investigative Site
city: Luebeck
country: Germany
facility: Novartis Investigative Site
city: Muenchen
country: Germany
facility: Novartis Investigative Site
city: Reinfeld
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facility: Novartis Investigative Site
city: Schwerin
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facility: Novartis Investigative Site
city: Baja
country: Hungary
facility: Novartis Investigative Site
city: Balassagyarmat
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
country: Hungary
facility: Novartis Investigative Site
city: Budapest
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facility: Novartis Investigative Site
city: Budapest
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facility: Novartis Investigative Site
city: Cegled
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facility: Novartis Investigative Site
city: Debrecen
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facility: Novartis Investigative Site
city: Godollo
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facility: Novartis Investigative Site
city: Gyor
country: Hungary
facility: Novartis Investigative Site
city: Gyula
country: Hungary
facility: Novartis Investigative Site
city: Kistelek
country: Hungary
facility: Novartis Investigative Site
city: Komarom
country: Hungary
facility: Novartis Investigative Site
city: Makó
country: Hungary
facility: Novartis Investigative Site
city: Mohacs
country: Hungary
facility: Novartis Investigative Site
city: Monor
country: Hungary
facility: Novartis Investigative Site
city: Mosonmagyarovar
country: Hungary
facility: Novartis Investigative Site
city: Nagykanizsa
country: Hungary
facility: Novartis Investigative Site
city: Nyiregyhaza
country: Hungary
facility: Novartis Investigative Site
city: Szeged
country: Hungary
facility: Novartis Investigative Site
city: Szikszo
country: Hungary
facility: Novartis Investigative Site
city: Szombathely
country: Hungary
facility: Novartis Investigative Site
city: Százhalombatta
country: Hungary
facility: Novartis Investigative Site
city: Torokbalint
country: Hungary
facility: Novartis Investigative Site
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Bangalore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Mysore
country: India
facility: Novartis Investigative Site
state: Karnataka
city: Pune
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facility: Novartis Investigative Site
state: Maharashtra
city: Coimbatore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Vellore
country: India
facility: Novartis Investigative Site
state: Tamil Nadu
city: Jaipur
country: India
facility: Novartis Investigative Site
city: Karamsad
country: India
facility: Novartis Investigative Site
city: Ludhiana
country: India
facility: Novartis Investigative Site
city: Nagpur
country: India
facility: Novartis Investigative Site
city: Thrissur
country: India
facility: Novartis Investigative Site
city: Toon-shi
country: Japan
facility: Novartis Investigative Site
state: Ehime
city: Mizunami-city
country: Japan
facility: Novartis Investigative Site
state: Gifu
city: Fukuyama-shi
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Kitahiroshima-shi
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Obihiro-shi
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Obihiro-shi
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-shi
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Tomakomai
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kobe-shi
country: Japan
facility: Novartis Investigative Site
state: Hyogo
city: Kawasaki-shi
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Kurashiki-city
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Kurashiki-shi
country: Japan
facility: Novartis Investigative Site
state: Okayama
city: Osaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sakai-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Suita
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Toyonaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Chiyoda-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Hachioji-city
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Tachikawa
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Rezekne
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Riga
country: Latvia
facility: Novartis Investigative Site
state: LV
city: Talsi
country: Latvia
facility: Novartis Investigative Site
state: LV
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: Kaunas
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
state: LT
city: Kaunas
country: Lithuania
facility: Novartis Investigative Site
city: Klaipeda
country: Lithuania
facility: Novartis Investigative Site
city: Vilnius
country: Lithuania
facility: Novartis Investigative Site
city: Kuching
country: Malaysia
facility: Novartis Investigative Site
state: Sarawak
city: Kota Kinabalu
country: Malaysia
facility: Novartis Investigative Site
city: Kuala Lumpur
country: Malaysia
facility: Novartis Investigative Site
city: Almere
country: Netherlands
facility: Novartis Investigative Site
state: The Netherlands
city: Eindhoven
country: Netherlands
facility: Novartis Investigative Site
state: The Netherlands
city: Leiderdorp
country: Netherlands
facility: Novartis Investigative Site
state: The Netherlands
city: Rotterdam
country: Netherlands
facility: Novartis Investigative Site
state: The Netherlands
city: Zoetermeer
country: Netherlands
facility: Novartis Investigative Site
state: The Netherlands
city: Geleen
country: Netherlands
facility: Novartis Investigative Site
city: Hoofddorp
country: Netherlands
facility: Novartis Investigative Site
city: Bialystok
country: Poland
facility: Novartis Investigative Site
city: Gdansk
country: Poland
facility: Novartis Investigative Site
city: Katowice
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Krakow
country: Poland
facility: Novartis Investigative Site
city: Lodz
country: Poland
facility: Novartis Investigative Site
city: Poznan
country: Poland
facility: Novartis Investigative Site
city: Skierniewice
country: Poland
facility: Novartis Investigative Site
city: Warszawa
country: Poland
facility: Novartis Investigative Site
city: Wroclaw
country: Poland
facility: Novartis Investigative Site
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
state: Nizhny Novgorod
city: Ekaterinburg
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Kazan
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Moscow
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Sankt-Peterburg
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: St. Petersburg
country: Russian Federation
facility: Novartis Investigative Site
state: Russia
city: Yaroslavl
country: Russian Federation
facility: Novartis Investigative Site
city: Bojnice
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Kosice
country: Slovakia
facility: Novartis Investigative Site
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city: Levice
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facility: Novartis Investigative Site
state: Slovak republic
city: Liptovsky Hradok
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Nitra
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Roznava
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Surany
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Trencin
country: Slovakia
facility: Novartis Investigative Site
state: Slovak Republic
city: Bratislava
country: Slovakia
facility: Novartis Investigative Site
city: Martin
country: Slovakia
facility: Novartis Investigative Site
city: Poprad
country: Slovakia
facility: Novartis Investigative Site
city: Ruzomberok
country: Slovakia
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Muang
country: Thailand
facility: Novartis Investigative Site
city: Rajathevee
country: Thailand
facility: Novartis Investigative Site
city: Ratchathewi
country: Thailand
facility: Novartis Investigative Site
city: Adana
country: Turkey
facility: Novartis Investigative Site
city: Bursa
country: Turkey
facility: Novartis Investigative Site
city: Gaziantep
country: Turkey
facility: Novartis Investigative Site
city: Istanbul
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Izmir
country: Turkey
facility: Novartis Investigative Site
city: Talas / Kayseri
country: Turkey
facility: Novartis Investigative Site
city: Dnipropetrovsk
country: Ukraine
facility: Novartis Investigative Site
city: Dnipropetrovsk
country: Ukraine
facility: Novartis Investigative Site
city: Donetsk
country: Ukraine
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kharkiv
country: Ukraine
facility: Novartis Investigative Site
city: Kyiv
country: Ukraine
facility: Novartis Investigative Site
city: Kyiv
country: Ukraine
facility: Novartis Investigative Site
city: Kyiv
country: Ukraine
facility: Novartis Investigative Site
city: Kyiv
country: Ukraine
facility: Novartis Investigative Site
city: Vinnytsia
country: Ukraine
facility: Novartis Investigative Site
city: Vinnytsia
country: Ukraine
facility: Novartis Investigative Site
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: