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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01555151
Other study ID # CQMF149E2201
Secondary ID 2011-005100-14
Status Completed
Phase Phase 2
First received March 13, 2012
Last updated April 10, 2015
Start date July 2012
Est. completion date July 2013

Study information

Verified date April 2015
Source Novartis
Contact n/a
Is FDA regulated No
Health authority Belgium: Federal Agency for Medicinal Products and Health ProductsCanada: Health CanadaEstonia: The State Agency of MedicineGermany: Federal Institute for Drugs and Medical DevicesHungary: National Institute for Quality - and Organizational Development in Healthcare and Medicines/National Institute of PharmacyIndia: Drugs Controller General of IndiaJapan: Pharmaceuticals and Medical Devices AgencyLatvia: State Agency of MedicinesLithuania: State Medicine Control Agency - Ministry of HealthNetherlands: Medicines Evaluation Board (MEB)Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal ProductsRussia: Expert Board (FSBI Scientific Center of Medical Application Expertise of Ministry of Health and Social Development of the Russian Federation)Slovakia: State Institute for Drug ConThailand: Food and Drug AdministrationTurkey: Ministry of HealthUkraine: Ministry of Health
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 739
Est. completion date July 2013
Est. primary completion date July 2013
Accepts healthy volunteers No
Gender Both
Age group 12 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
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
Device:
Concept 1
A single dose dry powder inhaler (SDDPI)
Twisthaler
A single dose dry powder inhaler (SDDPI)

Locations

Country Name City State
Belgium Novartis Investigative Site Kortrijk
Belgium Novartis Investigative Site Liège
Canada Novartis Investigative Site Mirabel Quebec
Canada Novartis Investigative Site Montreal Quebec
Canada Novartis Investigative Site Niagara Falls Ontario
Canada Novartis Investigative Site Quebec
Canada Novartis Investigative Site Trois-Rivières Quebec
Canada Novartis Investigative Site Windsor Ontario
Estonia Novartis Investigative Site Kohtla-Järve
Estonia Novartis Investigative Site Tallinn
Estonia Novartis Investigative Site Tartu
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Berlin
Germany Novartis Investigative Site Dresden
Germany Novartis Investigative Site Essen
Germany Novartis Investigative Site Goch
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hamburg
Germany Novartis Investigative Site Hannover
Germany Novartis Investigative Site Leipzig
Germany Novartis Investigative Site Luebeck
Germany Novartis Investigative Site Muenchen
Germany Novartis Investigative Site Reinfeld
Germany Novartis Investigative Site Schwerin
Hungary Novartis Investigative Site Baja
Hungary Novartis Investigative Site Balassagyarmat
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Budapest
Hungary Novartis Investigative Site Cegled
Hungary Novartis Investigative Site Debrecen
Hungary Novartis Investigative Site Godollo
Hungary Novartis Investigative Site Gyor
Hungary Novartis Investigative Site Gyula
Hungary Novartis Investigative Site Kistelek
Hungary Novartis Investigative Site Komarom
Hungary Novartis Investigative Site Makó
Hungary Novartis Investigative Site Mohacs
Hungary Novartis Investigative Site Monor
Hungary Novartis Investigative Site Mosonmagyarovar
Hungary Novartis Investigative Site Nagykanizsa
Hungary Novartis Investigative Site Nyiregyhaza
Hungary Novartis Investigative Site Százhalombatta
Hungary Novartis Investigative Site Szeged
Hungary Novartis Investigative Site Szikszo
Hungary Novartis Investigative Site Szombathely
Hungary Novartis Investigative Site Torokbalint
India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Bangalore Karnataka
India Novartis Investigative Site Coimbatore Tamil Nadu
India Novartis Investigative Site Jaipur
India Novartis Investigative Site Karamsad
India Novartis Investigative Site Ludhiana
India Novartis Investigative Site Mysore Karnataka
India Novartis Investigative Site Nagpur
India Novartis Investigative Site Pune Maharashtra
India Novartis Investigative Site Thrissur
India Novartis Investigative Site Vellore Tamil Nadu
Japan Novartis Investigative Site Chiyoda-ku Tokyo
Japan Novartis Investigative Site Chuo-ku Tokyo
Japan Novartis Investigative Site Chuo-ku Tokyo
Japan Novartis Investigative Site Fukuyama-shi Hiroshima
Japan Novartis Investigative Site Hachioji-city Tokyo
Japan Novartis Investigative Site Kawasaki-shi Kanagawa
Japan Novartis Investigative Site Kitahiroshima-shi Hokkaido
Japan Novartis Investigative Site Kobe-shi Hyogo
Japan Novartis Investigative Site Kurashiki-city Okayama
Japan Novartis Investigative Site Kurashiki-shi Okayama
Japan Novartis Investigative Site Mizunami-city Gifu
Japan Novartis Investigative Site Obihiro-shi Hokkaido
Japan Novartis Investigative Site Obihiro-shi Hokkaido
Japan Novartis Investigative Site Osaka-city Osaka
Japan Novartis Investigative Site Sakai-city Osaka
Japan Novartis Investigative Site Sapporo-shi Hokkaido
Japan Novartis Investigative Site Sapporo-shi Hokkaido
Japan Novartis Investigative Site Shinagawa-ku Tokyo
Japan Novartis Investigative Site Suita Osaka
Japan Novartis Investigative Site Tachikawa Tokyo
Japan Novartis Investigative Site Tomakomai Hokkaido
Japan Novartis Investigative Site Toon-shi Ehime
Japan Novartis Investigative Site Toshima-ku Tokyo
Japan Novartis Investigative Site Toyonaka-city Osaka
Latvia Novartis Investigative Site Rezekne LV
Latvia Novartis Investigative Site Riga LV
Latvia Novartis Investigative Site Riga
Latvia Novartis Investigative Site Riga
Latvia Novartis Investigative Site Riga
Latvia Novartis Investigative Site Talsi LV
Lithuania Novartis Investigative Site Kaunas LT
Lithuania Novartis Investigative Site Kaunas
Lithuania Novartis Investigative Site Klaipeda
Lithuania Novartis Investigative Site Klaipeda LT
Lithuania Novartis Investigative Site Vilnius
Malaysia Novartis Investigative Site Kota Kinabalu
Malaysia Novartis Investigative Site Kuala Lumpur
Malaysia Novartis Investigative Site Kuching Sarawak
Netherlands Novartis Investigative Site Almere The Netherlands
Netherlands Novartis Investigative Site Eindhoven The Netherlands
Netherlands Novartis Investigative Site Geleen
Netherlands Novartis Investigative Site Hoofddorp
Netherlands Novartis Investigative Site Leiderdorp The Netherlands
Netherlands Novartis Investigative Site Rotterdam The Netherlands
Netherlands Novartis Investigative Site Zoetermeer The Netherlands
Poland Novartis Investigative Site Bialystok
Poland Novartis Investigative Site Gdansk
Poland Novartis Investigative Site Katowice
Poland Novartis Investigative Site Krakow
Poland Novartis Investigative Site Krakow
Poland Novartis Investigative Site Lodz
Poland Novartis Investigative Site Poznan
Poland Novartis Investigative Site Skierniewice
Poland Novartis Investigative Site Warszawa
Poland Novartis Investigative Site Wroclaw
Russian Federation Novartis Investigative Site Ekaterinburg Russia
Russian Federation Novartis Investigative Site Kazan Russia
Russian Federation Novartis Investigative Site Moscow Russia
Russian Federation Novartis Investigative Site Sankt-Peterburg Russia
Russian Federation Novartis Investigative Site St. Petersburg Russia
Russian Federation Novartis Investigative Site St. Petersburg Nizhny Novgorod
Russian Federation Novartis Investigative Site Yaroslavl
Slovakia Novartis Investigative Site Bojnice Slovak Republic
Slovakia Novartis Investigative Site Bratislava Slovak Republic
Slovakia Novartis Investigative Site Bratislava Slovak Republic
Slovakia Novartis Investigative Site Bratislava
Slovakia Novartis Investigative Site Kosice Slovak Republic
Slovakia Novartis Investigative Site Levice Slovak republic
Slovakia Novartis Investigative Site Liptovsky Hradok Slovak Republic
Slovakia Novartis Investigative Site Martin
Slovakia Novartis Investigative Site Nitra Slovak Republic
Slovakia Novartis Investigative Site Poprad
Slovakia Novartis Investigative Site Roznava Slovak Republic
Slovakia Novartis Investigative Site Ruzomberok
Slovakia Novartis Investigative Site Surany Slovak Republic
Slovakia Novartis Investigative Site Trencin Slovak Republic
Thailand Novartis Investigative Site Muang
Thailand Novartis Investigative Site Muang
Thailand Novartis Investigative Site Rajathevee
Thailand Novartis Investigative Site Ratchathewi
Turkey Novartis Investigative Site Adana
Turkey Novartis Investigative Site Bursa
Turkey Novartis Investigative Site Gaziantep
Turkey Novartis Investigative Site Istanbul
Turkey Novartis Investigative Site Izmir
Turkey Novartis Investigative Site Izmir
Turkey Novartis Investigative Site Talas / Kayseri
Ukraine Novartis Investigative Site Dnipropetrovsk
Ukraine Novartis Investigative Site Dnipropetrovsk
Ukraine Novartis Investigative Site Donetsk
Ukraine Novartis Investigative Site Kharkiv
Ukraine Novartis Investigative Site Kharkiv
Ukraine Novartis Investigative Site Kharkiv
Ukraine Novartis Investigative Site Kyiv
Ukraine Novartis Investigative Site Kyiv
Ukraine Novartis Investigative Site Kyiv
Ukraine Novartis Investigative Site Kyiv
Ukraine Novartis Investigative Site Vinnytsia
Ukraine Novartis Investigative Site Vinnytsia

Sponsors (1)

Lead Sponsor Collaborator
Novartis Pharmaceuticals

Countries where clinical trial is conducted

Belgium,  Canada,  Estonia,  Germany,  Hungary,  India,  Japan,  Latvia,  Lithuania,  Malaysia,  Netherlands,  Poland,  Russian Federation,  Slovakia,  Thailand,  Turkey,  Ukraine, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment Forced Expiratory Volume in 1 second (FEV1) was measured via spirometry conducted according to internationally accepted standards. Measurements were taken on days 8, 15 and 22 after treatment. Data within 6 hr of rescue medication use is excluded from this analysis. Days 8, 15 and 22 No
Secondary Forced Vital Capacity (FVC) at All Time Points Forced Vital Capacity (FVC) is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. Data within 6 hr of rescue medication use is excluded from this analysis. Mixed model: FVC = treatment + gender+ baseline FVC + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. Days 1, 8, 15, 22, 28 and 29 at all time points No
Secondary Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points The Forced Expiratory Flow (FEF) 25%-75% measurement describes the amount of air expelled from the lungs during the middle half (25% - 75%) of the forced vital capacity test and is measured using spirometry. Days 1, 8, 15, 22, 28 and 29 at all time points No
Secondary Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points Forced Expiratory Volume in 1 second (FEV1)/Forced Vital Capacity (FVC) was measured via spirometry conducted according to internationally accepted standards. Data within 6 hr of rescue medication use is excluded from this analysis. Days 1, 8, 15, 22, 28 and 29 at all time points No
Secondary Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment Peak expiratory flow rate (PEFR) was measured via electronice Peak flow meter by patient at home. Mixed model used: change from baseline in the mean evening PEFR = treatment + age + gender + baseline evening PEFR + level of asthma control + region + center (region)+ error. Center is included as a random effect nested within region. Baseline and week 4 No
Secondary Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit Asthma symptoms were evaluated by the Asthma Control Questionnaire (ACQ). The ACQ-5 has five questions of the asthma symptoms to be answered by the patient. The overall score is the average of the 5 questions; a minimum overall score of 0 = good control of asthma whereas a maximum overall score of 6 = poor control of asthma. A negative change in score indicates improvement in symptoms. MIXED model: Change from baseline in ACQ-5 = treatment + gender + baseline ACQ-5 score + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. - Baseline ACQ-5 is defined as the questionnaire completed on Day 1 (randomization). Baseline, days 8,15,22 and 29 No
Secondary Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment Rescue medication data recorded during the 14 day run-in period is used to calculate the baseline. - Total number of puffs of rescue medication per day over the full 4 weeks is calculated and divided by the total number of days with non-missing rescue medication data to derive the mean daily number of puffs of rescue medication taken for the subject. - MIXED model: Change = treatment + gender + baseline mean daily number of puffs + age + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region. Baseline and 4 weeks No
Secondary Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment Mixed model used: percentage of days with no rescue medication use = treatment + age + gender + baseline percentage of days with no rescue use + level of asthma control + region + center (region) + error. Center is included as a random effect nested within region.
A day with no rescue use is defined from diary data as any day where the subject does not use any puffs of rescue medication.
The total number of days with no rescue use over the 4 week treatment period is divided by the total number of evaluable days in order to derive the percentage of days with no rescue use.
4 weeks No
Secondary Fractional Exhaled Nitric Oxide (FeNO) FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline. FeNO was measured on days 15 and 29 after treatment. Days 15 and 29 No
Secondary Plasma Cortisol Concentrations Blood samples were taken from each subject participating in the study post dose at day 1 and week 4. Cortisol concentrations were evaluated. Results are presented as nmol/L Baseline, days 1 and 28 Yes
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