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Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device in Adult and Adolescent Patients With Persistent Asthma

NCT ID: NCT01555151

Last Updated: 2015-05-01

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

739 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-07-31

Study Completion Date

2013-07-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Asthma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Mometasone furoate 80 μg

Description: Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 80 ug delivered via the Concept1 device for 4 weeks.

Group Type EXPERIMENTAL

Mometasone furoate

Intervention Type DRUG

Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device

Concept 1

Intervention Type DEVICE

A single dose dry powder inhaler (SDDPI)

Mometasone furoate 200 µg

Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 200 ug delivered via the Twisthaler® device for 4 weeks.

Group Type EXPERIMENTAL

Mometasone furoate

Intervention Type DRUG

Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device

Twisthaler

Intervention Type DEVICE

A single dose dry powder inhaler (SDDPI)

Mometasone furoate 320 µg

Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 320 ug delivered via the Concept1 device for 4 weeks.

Group Type EXPERIMENTAL

Mometasone furoate

Intervention Type DRUG

Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device

Concept 1

Intervention Type DEVICE

A single dose dry powder inhaler (SDDPI)

Mometasone furoate 800 µg

Mometasone furoate (MF) 800 ug delivered via the Twisthaler® device for 2 weeks, followed by MF 200 ug delivered via the Twisthaler® device for 2 weeks or no treatment for 2 weeks, then randomized to MF 800 ug delivered via the Twisthaler® device for 4 weeks.

Group Type EXPERIMENTAL

Mometasone furoate

Intervention Type DRUG

Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device

Twisthaler

Intervention Type DEVICE

A single dose dry powder inhaler (SDDPI)

Interventions

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Mometasone furoate

Mometasone furoate (MF) 80 µg once daily delivered via Concept1 device; MF 200 μg once daily delivered via Concept1 device; MF 320μg once daily delivered via Twisthaler® device or 800 μg once daily delivered via Twisthaler® device

Intervention Type DRUG

Concept 1

A single dose dry powder inhaler (SDDPI)

Intervention Type DEVICE

Twisthaler

A single dose dry powder inhaler (SDDPI)

Intervention Type DEVICE

Other Intervention Names

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QMF149

Eligibility Criteria

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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.

Exclusion Criteria

* 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).
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

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Novartis Investigative Site

Kortrijk, Belgium, Belgium

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Liège, Belgium, Belgium

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Niagara Falls, Ontario, Canada

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Windsor, Ontario, Canada

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Mirabel, Quebec, Canada

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Montreal, Quebec, Canada

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Québec, Quebec, Canada

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Trois-Rivières, Quebec, Canada

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Kohtla-Järve, Estonia, Estonia

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Tallinn, Estonia, Estonia

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Tartu, Estonia, Estonia

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Berlin, Germany, Germany

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Berlin, Germany, Germany

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Berlin, Germany, Germany

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Berlin, Germany, Germany

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Berlin, Germany, Germany

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Berlin, Germany, Germany

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Essen, Germany, Germany

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Hamburg, Germany, Germany

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Leipzig, Germany, Germany

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Lübeck, Germany, Germany

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Reinfeld, Germany, Germany

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Schwerin, Germany, Germany

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Dresden, , Germany

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Goch, , Germany

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Hamburg, , Germany

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Hanover, , Germany

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München, , Germany

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Balassagyarmat, Hungary, Hungary

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Budapest, Hungary, Hungary

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Budapest, Hungary, Hungary

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Budapest, Hungary, Hungary

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Budapest, Hungary, Hungary

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Cegléd, Hungary, Hungary

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Debrecen, Hungary, Hungary

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Komárom, Hungary, Hungary

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Monor, Hungary, Hungary

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Nyíregyháza, Hungary, Hungary

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Százhalombatta, Hungary, Hungary

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Szeged, Hungary, Hungary

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Szikszó, Hungary, Hungary

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Törökbálint, Hungary, Hungary

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Baja, , Hungary

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Budapest, , Hungary

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Budapest, , Hungary

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Gödöllő, , Hungary

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Győr, , Hungary

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Gyula, , Hungary

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Kistelek, , Hungary

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Makó, , Hungary

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Mohács, , Hungary

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Mosonmagyaróvár, , Hungary

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Nagykanizsa, , Hungary

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Szombathely, , Hungary

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Jaipur, India, India

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Karamsad, India, India

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Ludhiana, India, India

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Nagpur, India, India

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Thrissur, India, India

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Bangalore, Karnataka, India

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Coimbatore, Tamil Nadu, India

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Vellore, Tamil Nadu, India

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Toon-shi, Ehime, Japan

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Mizunami, Gifu, Japan

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Fukuyama-shi, Hiroshima, Japan

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Kitahiroshima-shi, Hokkaido, Japan

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Obihiro-shi, Hokkaido, Japan

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Sapporo, Hokkaido, Japan

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Tomakomai, Hokkaido, Japan

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Kobe, Hyōgo, Japan

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Kawasaki-shi, Kanagawa, Japan

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Kurashiki, Okayama-ken, Japan

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Kurashiki-shi, Okayama-ken, Japan

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Osaka, Osaka, Japan

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Suita, Osaka, Japan

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Toyonaka, Osaka, Japan

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Chiyoda-ku, Tokyo, Japan

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Toshima-ku, Tokyo, Japan

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Rēzekne, LV, Latvia

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Riga, LV, Latvia

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Talsi, LV, Latvia

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Riga, , Latvia

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Riga, , Latvia

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Riga, , Latvia

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Kaunas, LT, Lithuania

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Klaipėda, LT, Lithuania

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Kaunas, , Lithuania

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Klaipėda, , Lithuania

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Vilnius, , Lithuania

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Kota Kinabalu, Malaysia, Malaysia

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Kuching, Sarawak, Malaysia

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Kuala Lumpur, , Malaysia

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Almere Stad, The Netherlands, Netherlands

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Eindhoven, The Netherlands, Netherlands

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Leiderdorp, The Netherlands, Netherlands

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Rotterdam, The Netherlands, Netherlands

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Zoetermeer, The Netherlands, Netherlands

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Geleen, , Netherlands

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Hoofddorp, , Netherlands

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Bialystok, Poland, Poland

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Katowice, Poland, Poland

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Poznan, Poland, Poland

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Gdansk, , Poland

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Skierniewice, , Poland

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Saint Petersburg, Nizhny Novgorod Oblast, Russia

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Kazan', Russia, Russia

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Moscow, Russia, Russia

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Saint Petersburg, Russia, Russia

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Saint Petersburg, Russia, Russia

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Yekaterinburg, Russia, Russia

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Yaroslavl, , Russia

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Bojnice, Slovak Republic, Slovakia

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Bratislava, Slovak Republic, Slovakia

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Bratislava, Slovak Republic, Slovakia

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Košice, Slovak Republic, Slovakia

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Levice, Slovak Republic, Slovakia

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Liptovský Hrádok, Slovak Republic, Slovakia

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Nitra, Slovak Republic, Slovakia

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Rožňava, Slovak Republic, Slovakia

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Šurany, Slovak Republic, Slovakia

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Trenčín, Slovak Republic, Slovakia

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Martin, Slovakia, Slovakia

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Poprad, Slovakia, Slovakia

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Ružomberok, Slovakia, Slovakia

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Bratislava, , Slovakia

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Muang, Thailand, Thailand

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Muang, Thailand, Thailand

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Rajathevee, Thailand, Thailand

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Ratchathewi, Thailand, Thailand

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Adana, Turkey, Turkey (Türkiye)

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Bursa, Turkey, Turkey (Türkiye)

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Gaziantep, Turkey, Turkey (Türkiye)

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Istanbul, Turkey, Turkey (Türkiye)

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Izmir, Turkey, Turkey (Türkiye)

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Izmir, Turkey, Turkey (Türkiye)

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Talas / Kayseri, , Turkey (Türkiye)

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Dnipropetrovsk, Ukraine, Ukraine

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Dnipropetrovsk, Ukraine, Ukraine

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Donetsk, Ukraine, Ukraine

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Kharkiv, Ukraine, Ukraine

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Kharkiv, Ukraine, Ukraine

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Kharkiv, Ukraine, Ukraine

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Kyiv, Ukraine, Ukraine

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Kyiv, Ukraine, Ukraine

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Kyiv, Ukraine, Ukraine

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Kyiv, Ukraine, Ukraine

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Vinnytsia, Ukraine, Ukraine

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Vinnytsia, Ukraine, Ukraine

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Countries

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Belgium Canada Estonia Germany Hungary India Japan Latvia Lithuania Malaysia Netherlands Poland Russia Slovakia Thailand Turkey (Türkiye) Ukraine

Other Identifiers

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2011-005100-14

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

CQMF149E2201

Identifier Type: -

Identifier Source: org_study_id

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