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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier:
NCT01555151
First received: March 13, 2012
Last updated: August 21, 2013
Last verified: August 2013
  Purpose

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


Condition Intervention Phase
Asthma
Drug: Mometasone Furoate
Phase 2

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

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Trough Forced Expiratory Volume in one second (FEV1) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 23 hour 10 minute and 23 hour 45 minute post dose FEV1 readings.


Secondary Outcome Measures:
  • FEV1 at each timepoint [ Time Frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29 ] [ Designated as safety issue: No ]
    Spirometry is conducted according to the global standard. FEV1 is measured at pre-dose and post dose up to 4 hours on Day 1 and Day 28, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minute on Day 2 and Day 29, and at pre-dose 50 minute and 15 minute on Day 8, Day 15, and Day 22.

  • Forced vital capacity (FVC) at each timepoint [ Time Frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29 ] [ Designated as safety issue: No ]
    Spirometry is conducted according to the global standard. FVC is measured at pre-dose and post dose up to 4 hour on Day 1 and Day 28, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minutes on Day 2 and Day 29, and at pre-dose 50 min and 15 min on Day 8, Day 15, and Day 22.

  • Forced Expiratory Flow between 25% and 75% (FEF25-75%) at each timepoint [ Time Frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29 ] [ Designated as safety issue: No ]
    Spirometry is conducted according to the global standard. FEF25-75% is measured at pre-dose and post dose up to 4 hour on Day 1 and Day 28, at post dose 12 hour, 23 hour 10 minute and 23 hour 45 minute on Day 2 and Day 29, and at pre-dose 50 minute and 15 minute on Day 8, Day 15, and Day 22.

  • Trough FEV1 [ Time Frame: 1 week, 2 weeks, 3 weeks ] [ Designated as safety issue: No ]
    Spirometry is conducted according to the global standard. Trough FEV1 is defined as the average of the 50 minute and 15 minute pre dose FEV1 readings.

  • Morning and evening peak expiratory flow rate (PEFR) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    PEFR is measured with portable spirometer by participants every morning and evening at home.

  • Asthma Control Questionnaire 5 (ACQ-5) [ Time Frame: 1 week, 2 weeks, 3 weeks, 4 weeks ] [ Designated as safety issue: No ]

    The ACQ-5 is a validated questionnaire consisting of 5 items for the assessment of asthma symptom which are night symptom, morning symptom, limitation for the activities, shortness of breath, and wheeze.

    Each item is graded on a scale of 0-6 and the questions are equally weighted. The ACQ-5 score is the mean of the 5 questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled).


  • The usage of rescue medication (short acting β2-agonist) [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]
    Participants record the number of puffs of rescue medication taken in the previous 12 hours in the morning and evening.

  • FeNO (Fractional exhaled Nitric Oxide) [ Time Frame: 2 weeks, 4 weeks ] [ Designated as safety issue: No ]
    FeNO is widely accepted as a non-invasive marker for airway inflammation such as asthma and conducted according to published guideline.

  • Adverse events, laboratory analysis, vital signs and ECG [ Time Frame: 4 weeks ] [ Designated as safety issue: Yes ]
    Adverse event, laboratory tests (haematology, clinical chemistry and urinalysis), vital signs (i.e. blood pressure, pulse rate), and ECG (e.g. quantitative assessments - heart rate, QTc, PRS, PR intervals)

  • Plasma cortisol concentrations at each timepoint [ Time Frame: Day 1, Day 2, Day 8, Day 15, Day 22, Day 28, Day 29 ] [ Designated as safety issue: Yes ]
    Plasma cortisol to be measured at central laboratory. Blood sample for Plasma cortisol is collected at pre-dose and post dose up to 4 hour on Day 1 and Day 28, post dose 12 hour, 23 hour 35 minute on Day 2 and Day 29, and at pre-dose 25 minute on Day 8, Day 15, and Day 22.


Enrollment: 616
Study Start Date: July 2012
Study Completion Date: July 2013
Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Mometasone furoate 80 µg
Mometasone furoate 80 µg o.d. delivered via Concept1
Drug: Mometasone Furoate
Mometasone Furoate was delivered by a Concept1 or Twisthaler® inhaler
Experimental: Mometasone furoate 320 µg
Mometasone furoate 320 µg o.d. delivered via Concept1
Drug: Mometasone Furoate
Mometasone Furoate was delivered by a Concept1 or Twisthaler® inhaler
Experimental: Mometasone furoate 200 µg
Mometasone furoate 200 µg o.d. delivered via Twisthaler®
Drug: Mometasone Furoate
Mometasone Furoate was delivered by a Concept1 or Twisthaler® inhaler
Experimental: Mometasone furoate 800 µg
Mometasone furoate 800 µg o.d. delivered via Twisthaler®
Drug: Mometasone Furoate
Mometasone Furoate was delivered by a Concept1 or Twisthaler® inhaler

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with persistent asthma, diagnosed according to GINA 2010 guideline and who additionally meet the following criteria:
  • Patients who are receiving ICS treatment
  • Patients whose level of asthma control is "Partly Controlled" or "Uncontrolled"
  • Patients with a pre-bronchodilator FEV1 value of ≤ 80% of predicted normal value
  • Patients who demonstrate an increase of >= 12% and 200 mL in FEV1
  • Patients who are confirmed as "ICS sensitive" by ACQ-5 questionnaire and FEV1.

Exclusion Criteria:

  • Patients who are current smokers or have a smoking history of greater than 10 pack years (defined as the number of packs of 20 cigarettes smoked per day multiplied by number of years the patient smoked).
  • Patients diagnosed with COPD as defined by the GOLD 2010 guidelines.
  • 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.

Other protocol-defined inclusion/exclusion criteria may apply

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01555151

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Belgium
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Liège, Belgium, 4000
Canada, Ontario
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Niagara Falls, Ontario, Canada, L2G 1J4
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Windsor, Ontario, Canada, N8X 5A6
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Bursa, Turkey, 16059
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Gaziantep, Turkey, 27310
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Istanbul, Turkey, 35100
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Izmir, Turkey, 34890
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Talas / Kayseri, Turkey, 38039
Ukraine
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Dnipropetrovsk, Ukraine, 49066
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Dnipropetrovsk, Ukraine, 49051
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Donetsk, Ukraine, 83003
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Kharkiv, Ukraine, 61039
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Kharkiv, Ukraine, 61098
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Kharkiv, Ukraine, 49066
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Kyiv, Ukraine, 4050
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Kyiv, Ukraine, 1004
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Kyiv, Ukraine, 3680
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Kyiv, Ukraine, 6115
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Vinnytsia, Ukraine, 21029
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Vinnytsia, Ukraine, 20129
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

No publications provided

Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT01555151     History of Changes
Other Study ID Numbers: CQMF149E2201, 2011-005100-14
Study First Received: March 13, 2012
Last Updated: August 21, 2013
Health Authority: United States: Food and Drug Administration
Belgium: Federal Agency for Medicinal Products and Health Products
Canada: Health Canada
Estonia: The State Agency of Medicine
Germany: Federal Institute for Drugs and Medical Devices
Hungary: National Institute for Quality - and Organizational Development in Healthcare and Medicines/National Institute of Pharmacy
India: Drugs Controller General of India
Japan: Pharmaceuticals and Medical Devices Agency
Latvia: State Agency of Medicines
Lithuania: State Medicine Control Agency - Ministry of Health
Netherlands: Medicines Evaluation Board (MEB)
Poland: Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Russia: 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 Con
Thailand: Food and Drug Administration
Turkey: Ministry of Health
Ukraine: Ministry of Health

Keywords provided by Novartis:
Asthma

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone furoate
Anti-Allergic Agents
Therapeutic Uses
Pharmacologic Actions
Anti-Inflammatory Agents

ClinicalTrials.gov processed this record on July 23, 2014