Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device 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: September 14, 2014
Last verified: September 2014

March 13, 2012
September 14, 2014
July 2012
July 2013   (final data collection date for primary outcome measure)
Trough Forced Expiratory Volume in 1 Second (FEV1) [ Time Frame: Day 29 ] [ Designated as safety issue: No ]
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.
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.
Complete list of historical versions of study NCT01555151 on ClinicalTrials.gov Archive Site
  • Trough Forced Expiratory Volume in 1 Second (FEV1) After Days 8, 15 and 22 of Treatment [ Time Frame: Days 8, 15 and 22 ] [ Designated as safety issue: No ]
    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.
  • Forced Vital Capacity (FVC) at All Time Points [ Time Frame: Days 1, 8, 15, 22, 28 and 29 at all time points ] [ Designated as safety issue: No ]
    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.
  • Forced Expiratory Flow Between 25% and 75% (FEF25-75%) at All Time Points [ Time Frame: Days 1, 8, 15, 22, 28 and 29 at all time points ] [ Designated as safety issue: No ]
    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.
  • Forced Expiratory Volume in 1 Second Forced Vital Capacity (FEV1/FVC) Percent at All Time Points [ Time Frame: Days 1, 8, 15, 22, 28 and 29 at all time points ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Mean Morning and Evening Peak Expiratory Flow Rate (PEFR) Over 4 Weeks of Treatment [ Time Frame: Baseline and week 4 ] [ Designated as safety issue: No ]
    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.
  • Change From Baseline in Asthma Control Questionnaire (ACQ-5) by Visit [ Time Frame: Baseline, days 8,15,22 and 29 ] [ Designated as safety issue: No ]
    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).
  • Change From Baseline in Mean Daily Number of Puffs of Rescue Medication Over 4 Weeks of Treatment [ Time Frame: Baseline and 4 weeks ] [ Designated as safety issue: No ]
    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.
  • Percentage of Days With no Rescue Medication Use Over 4 Weeks of Treatment [ Time Frame: 4 weeks ] [ Designated as safety issue: No ]

    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.

  • Fractional Exhaled Nitric Oxide (FeNO) [ Time Frame: Days 15 and 29 ] [ 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. FeNO was measured on days 15 and 29 after treatment.
  • Plasma Cortisol Concentrations [ Time Frame: Baseline, days 1 and 28 ] [ Designated as safety issue: Yes ]
    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
  • 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.
Not Provided
Not Provided
 
Safety and Efficacy of Mometasone Furoate Delivered Via Concept1 Device or Twisthaler® Device 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 device or Twisthaler® device 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 (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
    Other Name: QMF149
  • Device: Concept 1
    A single dose dry powder inhaler (SDDPI)
  • Device: Twisthaler
    A single dose dry powder inhaler (SDDPI)
  • Experimental: 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.
    Interventions:
    • Drug: Mometasone furoate
    • Device: Concept 1
  • Experimental: 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.
    Interventions:
    • Drug: Mometasone furoate
    • Device: Twisthaler
  • Experimental: 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.
    Interventions:
    • Drug: Mometasone furoate
    • Device: Concept 1
  • Experimental: 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.
    Interventions:
    • Drug: Mometasone furoate
    • Device: Twisthaler
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
739
July 2013
July 2013   (final data collection date for primary outcome measure)

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

Both
12 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Hungary,   Belgium,   Canada,   Estonia,   Germany,   Ukraine,   India,   Japan,   Latvia,   Lithuania,   Malaysia,   Netherlands,   Poland,   Russian Federation,   Slovakia,   Thailand,   Turkey
 
NCT01555151
CQMF149E2201, 2011-005100-14
No
Novartis ( Novartis Pharmaceuticals )
Novartis Pharmaceuticals
Not Provided
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
Novartis
September 2014

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