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

March 13, 2012
August 21, 2013
July 2012
July 2013   (final data collection date for primary outcome measure)
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.
Same as current
Complete list of historical versions of study NCT01555151 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 or Twisthaler® in Adult and Adolescent Patients With Persistent Asthma
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

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.

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Asthma
Drug: Mometasone Furoate
Mometasone Furoate was delivered by a Concept1 or Twisthaler® inhaler
  • Experimental: Mometasone furoate 80 µg
    Mometasone furoate 80 µg o.d. delivered via Concept1
    Intervention: Drug: Mometasone Furoate
  • Experimental: Mometasone furoate 320 µg
    Mometasone furoate 320 µg o.d. delivered via Concept1
    Intervention: Drug: Mometasone Furoate
  • Experimental: Mometasone furoate 200 µg
    Mometasone furoate 200 µg o.d. delivered via Twisthaler®
    Intervention: Drug: Mometasone Furoate
  • Experimental: Mometasone furoate 800 µg
    Mometasone furoate 800 µg o.d. delivered via Twisthaler®
    Intervention: Drug: Mometasone Furoate
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
616
July 2013
July 2013   (final data collection date for primary outcome measure)

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

Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Belgium,   Canada,   Estonia,   Germany,   Hungary,   India,   Japan,   Latvia,   Lithuania,   Malaysia,   Netherlands,   Poland,   Russian Federation,   Slovakia,   Thailand,   Turkey,   Ukraine
 
NCT01555151
CQMF149E2201, 2011-005100-14
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
August 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP