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

NCT01555151 | Completed Phase 2 Results

• 2 other identifiers: CQMF149E22012011-005100-14
• Study Type: interventional
• Target: 739
• Locations: 17 countries
• Sites: 165

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.

Conditions

Asthma

Keywords

Asthma

Outcome Measures

Primary Outcomes (1)

• Trough Forced Expiratory Volume in 1 Second (FEV1)

  Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on day 29 after treatment.

  Day 29

Secondary Outcomes (10)

• Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment

  Days 8, 15 and 22

• Forced Vital Capacity (FVC) at All Time Points

  Days 1, 8, 15, 22, 28 and 29 at all time points

• Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points

  Days 1, 8, 15, 22, 28 and 29 at all time points

• Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points

  Days 1, 8, 15, 22, 28 and 29 at all time points

• Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment

  Baseline and week 4

Study Arms (4)

Mometasone furoate 80 μg

EXPERIMENTAL

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.

Drug: Mometasone furoate; Device: Concept 1

Mometasone furoate 200 µg

EXPERIMENTAL

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.

Drug: Mometasone furoate; Device: Twisthaler

Mometasone furoate 320 µg

EXPERIMENTAL

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.

Drug: Mometasone furoate; Device: Concept 1

Mometasone furoate 800 µg

EXPERIMENTAL

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.

Drug: Mometasone furoate; Device: Twisthaler

Interventions

Mometasone furoate 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

Also known as: QMF149

Mometasone furoate 200 µg; Mometasone furoate 320 µg; Mometasone furoate 80 μg; Mometasone furoate 800 µg

Concept 1 DEVICE

A single dose dry powder inhaler (SDDPI)

Mometasone furoate 320 µg; Mometasone furoate 80 μg

Twisthaler DEVICE

A single dose dry powder inhaler (SDDPI)

Mometasone furoate 200 µg; Mometasone furoate 800 µg

Eligibility Criteria

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

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (165)

Novartis Investigative Site

Kortrijk, Belgium, 8500, Belgium

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Liège, Belgium, 4000, Belgium

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Niagara Falls, Ontario, L2G 1J4, Canada

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Windsor, Ontario, N8X 5A6, Canada

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Mirabel, Quebec, J7J 2K8, Canada

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Montreal, Quebec, H3G 1L5, Canada

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Québec, Quebec, GIV 4M6, Canada

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Trois-Rivières, Quebec, G8T 7A1, Canada

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Kohtla-Järve, Estonia, 30321, Estonia

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Tallinn, Estonia, 10138, Estonia

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Tartu, Estonia, 51014, Estonia

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Berlin, Germany, 10117, Germany

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Berlin, Germany, 10696, Germany

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Berlin, Germany, 10717, Germany

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Berlin, Germany, 12203, Germany

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Berlin, Germany, 14050, Germany

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Berlin, Germany, 14057, Germany

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Essen, Germany, 45355, Germany

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Hamburg, Germany, 22143, Germany

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Leipzig, Germany, 4207, Germany

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Lübeck, Germany, 23562, Germany

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Reinfeld, Germany, 23858, Germany

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Schwerin, Germany, 19055, Germany

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Dresden, 01069, Germany

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Goch, 47574, Germany

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Hamburg, 20253, Germany

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Hanover, 30317, Germany

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München, 80539, Germany

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Balassagyarmat, Hungary, 2660, Hungary

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Budapest, Hungary, 1036, Hungary

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Budapest, Hungary, 1041, Hungary

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Budapest, Hungary, 1122, Hungary

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Budapest, Hungary, 1135, Hungary

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Cegléd, Hungary, 2700, Hungary

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Debrecen, Hungary, 4031, Hungary

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Komárom, Hungary, 2900, Hungary

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Monor, Hungary, 2200, Hungary

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Nyíregyháza, Hungary, 4400, Hungary

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Százhalombatta, Hungary, 2440, Hungary

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Szeged, Hungary, 6722, Hungary

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Szikszó, Hungary, 3800, Hungary

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Törökbálint, Hungary, 2045, Hungary

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Baja, 6500, Hungary

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Budapest, 1033, Hungary

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Budapest, 1121, Hungary

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Gödöllő, 2100, Hungary

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Győr, 9024, Hungary

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Gyula, 5700, Hungary

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Kistelek, 6760, Hungary

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Makó, 6900, Hungary

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Mohács, 7700, Hungary

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Mosonmagyaróvár, 9200, Hungary

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Nagykanizsa, 8800, Hungary

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Szombathely, 9700, Hungary

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Jaipur, India, 302001, India

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Karamsad, India, 388225, India

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Ludhiana, India, 141001, India

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Nagpur, India, 400012, India

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Thrissur, India, 680002, India

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Bangalore, Karnataka, 560 010, India

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Bangalore, Karnataka, 560043, India

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Bangalore, Karnataka, 560054, India

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Mysore, Karnataka, 570004, India

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Pune, Maharashtra, 411 014, India

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Coimbatore, Tamil Nadu, 641 045., India

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Vellore, Tamil Nadu, 632 004, India

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Toon-shi, Ehime, 791-0281, Japan

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Mizunami, Gifu, 509-6134, Japan

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Fukuyama-shi, Hiroshima, 720-0001, Japan

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Kitahiroshima-shi, Hokkaido, 061-1121, Japan

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Obihiro-shi, Hokkaido, 080-0013, Japan

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Obihiro-shi, Hokkaido, 080-0805, Japan

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Sapporo, Hokkaido, 004-0022, Japan

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Sapporo, Hokkaido, 065-0025, Japan

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Tomakomai, Hokkaido, 053-8506, Japan

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Kobe, Hyōgo, 653-0021, Japan

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Kawasaki-shi, Kanagawa, 211-0041, Japan

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Kurashiki, Okayama-ken, 712-8064, Japan

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Kurashiki-shi, Okayama-ken, 713-8103, Japan

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Osaka, Osaka, 530-0001, Japan

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Sakai, Osaka, 591-8555, Japan

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Suita, Osaka, 565-0853, Japan

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Toyonaka, Osaka, 560-0082, Japan

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Chiyoda-ku, Tokyo, 102-0083, Japan

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Chuo-ku, Tokyo, 103-0027, Japan

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Chuo-ku, Tokyo, 103-0028, Japan

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Hachiōji, Tokyo, 192-0032, Japan

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Shinagawa-ku, Tokyo, 140-0011, Japan

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Tachikawa, Tokyo, 190-0013, Japan

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Toshima-ku, Tokyo, 171-0014, Japan

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Rēzekne, LV, LV-4600, Latvia

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Riga, LV, 1002, Latvia

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Talsi, LV, LV3201, Latvia

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Riga, 1002, Latvia

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Riga, LV-1004, Latvia

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Riga, LV-1038, Latvia

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Kaunas, LT, 44320, Lithuania

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Klaipėda, LT, 92288, Lithuania

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Kaunas, 50009, Lithuania

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Klaipėda, LT-92231, Lithuania

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Vilnius, LT-08661, Lithuania

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Kota Kinabalu, Malaysia, 88586, Malaysia

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Kuching, Sarawak, 93586, Malaysia

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Kuala Lumpur, 59100, Malaysia

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Almere Stad, The Netherlands, 1311 RL, Netherlands

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Eindhoven, The Netherlands, 5616GB, Netherlands

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Leiderdorp, The Netherlands, 2352 RA, Netherlands

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Rotterdam, The Netherlands, 3021 HC, Netherlands

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Zoetermeer, The Netherlands, 2724 EK, Netherlands

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Geleen, 6166 GR, Netherlands

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Hoofddorp, 2134 TM, Netherlands

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Bialystok, Poland, 15-445, Poland

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Katowice, Poland, 40-954, Poland

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Krakow, Poland, 30-510, Poland

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Krakow, Poland, 31-637, Poland

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Lodz, Poland, 95-100, Poland

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Poznan, Poland, 60-693, Poland

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Warsaw, Poland, 01-868, Poland

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Wroclaw, Poland, 50-445, Poland

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Gdansk, 80-952, Poland

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Skierniewice, 96-100, Poland

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Saint Petersburg, Nizhny Novgorod Oblast, 194356, Russia

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Kazan', Russia, 420012, Russia

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Moscow, Russia, 109240, Russia

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Saint Petersburg, Russia, 194044, Russia

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Saint Petersburg, Russia, 197022, Russia

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Yekaterinburg, Russia, 620109, Russia

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Yaroslavl, 150003, Russia

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Bojnice, Slovak Republic, 972 01, Slovakia

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Bratislava, Slovak Republic, 831 03, Slovakia

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Bratislava, Slovak Republic, 83101, Slovakia

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Košice, Slovak Republic, 040 01, Slovakia

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Levice, Slovak Republic, 934 01, Slovakia

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Liptovský Hrádok, Slovak Republic, 033 01, Slovakia

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Nitra, Slovak Republic, 949 01, Slovakia

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Rožňava, Slovak Republic, 4801, Slovakia

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Šurany, Slovak Republic, 942 01, Slovakia

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Trenčín, Slovak Republic, 91108, Slovakia

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Martin, Slovakia, 036 59, Slovakia

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Poprad, Slovakia, 05845, Slovakia

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Ružomberok, Slovakia, 034 26, Slovakia

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Bratislava, 833 40, Slovakia

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Muang, Thailand, 11000, Thailand

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Muang, Thailand, 30000, Thailand

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Rajathevee, Thailand, 10400, Thailand

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Ratchathewi, Thailand, 10400, Thailand

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Adana, Turkey, 01330, Turkey (Türkiye)

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Bursa, Turkey, 16059, Turkey (Türkiye)

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Gaziantep, Turkey, 27310, Turkey (Türkiye)

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Istanbul, Turkey, 35100, Turkey (Türkiye)

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Izmir, Turkey, 34890, Turkey (Türkiye)

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Izmir, Turkey, 35040, Turkey (Türkiye)

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Talas / Kayseri, 38039, Turkey (Türkiye)

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Dnipropetrovsk, Ukraine, 49066, Ukraine

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Dnipropetrovsk, Ukraine, 49074, Ukraine

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Donetsk, Ukraine, 83003, Ukraine

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Kharkiv, Ukraine, 61039, Ukraine

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Kharkiv, Ukraine, 61098, Ukraine

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Kharkiv, Ukraine, 61124, Ukraine

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Kyiv, Ukraine, 04050, Ukraine

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Kyiv, Ukraine, 1004, Ukraine

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Kyiv, Ukraine, 3680, Ukraine

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Kyiv, Ukraine, 4050, Ukraine

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Vinnytsia, Ukraine, 20129, Ukraine

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Novartis Investigative Site

Vinnytsia, Ukraine, 21029, Ukraine

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MeSH Terms

Conditions

Asthma

Interventions

Mometasone Furoate; QMF149

Condition Hierarchy (Ancestors)

Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Clinical Disclosure Office
• Organization: Novartis Pharmaceuticals

+1(862)778-8300

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2012
• First Posted: March 15, 2012
• Study Start: July 1, 2012
• Primary Completion: July 1, 2013
• Study Completion: July 1, 2013
• Last Updated: May 1, 2015
• Results First Posted: August 1, 2014

Record last verified: 2015-04

Locations

IN (12); NL (7); DE (17); ES (3); TH (4); UA (12); SL (14); LA (6); PL (10); RU (7); TU (7); BE (2); CA (6); MY (3); LI (5); JP (24); HU (26)