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A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma

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ClinicalTrials.gov Identifier: NCT02554786
Recruitment Status : Recruiting
First Posted : September 18, 2015
Last Update Posted : March 14, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of the trial is to evaluate the efficacy and safety of two different doses of QMF149 (QMF149 150/160 µg and QMF149 150/320 µg via Concept1) over two respective MF doses (MF 400 µg and MF 800 µg via Twisthaler® (total daily dose)) in poorly controlled asthmatic patients as determined by pulmonary function testing, and effects on asthma control

Condition or disease Intervention/treatment Phase
Asthma Drug: QMF149 Drug: MF 400 Drug: salmeterol /fluticasone Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2000 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Multicenter Randomized 52 Week Treatment Double-blind, Triple Dummy Parallel Group Study to Assess the Efficacy and Safety of QMF149 Compared to Mometasone Furoate in Patients With Asthma
Actual Study Start Date : December 29, 2015
Estimated Primary Completion Date : July 25, 2019
Estimated Study Completion Date : July 25, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: QMF149 150/160 µg
QMF149 150/160 µg o.d. via Concept1
Drug: QMF149
Experimental: QMF149 150/320 µg
QMF149 150/320 µg o.d. via Concept1
Drug: QMF149
Active Comparator: MF 400 µg o.d.
MF 400 µg o.d via Twisthaler®
Drug: MF 400
Active Comparator: MF 400 µg b.i.d.
MF 400 µg b.i.d. via Twisthaler®
Drug: MF 400
Active Comparator: salmeterol /fluticasone
salmeterol xinafoate /fluticasone propionate 50/500 µg b.i.d. via Diskus®
Drug: salmeterol /fluticasone



Primary Outcome Measures :
  1. trough FEV1 [ Time Frame: 26 weeks ]

    demonstrate the superiority of either QMF149 150/160 µg delivered via Concept1 o.d. (in the evening) to MF 400 µg o.d (in the evening) delivered via Twisthaler® or QMF149 150/320 µg delivered via Concept1 o.d. (in the evening) to MF 800 µg delivered via Twisthaler® (delivered as 400 µg b.i.d.)

    Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing



Secondary Outcome Measures :
  1. Trough FEV1 at week 52 [ Time Frame: week 52 ]
    Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing

  2. pre-dose FEV1 at week 4 and week 12 [ Time Frame: 12 weeks ]
    Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing

  3. FEV1 over 52 weeks [ Time Frame: 52 weeks ]
    Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured through spirometry testing

  4. PEF over 26 and 52 weeks [ Time Frame: 52 weeks ]
    measured in the morning and evening. PEF is the peak expiratory flow, the maximum speed of expiration

  5. ACQ-7 at week 4, 12, 26 and 52 [ Time Frame: 52 weeks ]
    ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control

  6. % patients with MID of ACQ>=0,5 at week 26 and 52 [ Time Frame: 52 weeks ]
    MID is Minimum Important Difference. ACQ-7 is an asthma control questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and daily rescue bronchodilator use entered by the patient) validated to evaluate different levels of asthma control.

  7. daily e-diary over 52 weeks [ Time Frame: 52 weeks ]
    % of asthma symptoms free, no day-time symptoms, % night with no awakenings, % morning with no symptoms

  8. rescue medication use over 26 and 52 weeks [ Time Frame: 52 weeks ]

    mean daily, nighttime, daytime. A day with no rescue medication use is defined from the diary data as any day where the patient recorded no rescue medicine use during the previous 12 hours.

    Baseline mean daily, daytime and nighttime (combined) number of puffs is defined as the average of the respective number of puffs. Only patients with a value at both baseline and post-baseline visits will be included


  9. asthma exacerbation over 52 weeks [ Time Frame: 52 weeks ]
    By exacerbation category : time to first exacerbation, time to first hospitalization due to exacerbation, annual rate of asthma exacerbation, duration in days of exacerbations, % patient with at least one exacerbation, time to permanent discontinuation of study medication due to exacerbation, % patient who discontinued permanently of study medication due to exacerbation, total amount of corticosteroids used to treat exacerbation

  10. % rescue medication free days over 26 and 52 weeks [ Time Frame: 52 weeks ]
    rescue medication: albuterol/salbutamol

  11. quality of life assessed by AQLQ-S 12 [ Time Frame: 52 weeks ]
    Asthma Quality of Life questionnaire

  12. incidence of composite endpoint of serious asthma outcomes [ Time Frame: 52 weeks ]
    asthma related hospitalization, asthma related intubation, asthma related death

  13. Adverse event, vital signs, ECG and laboratory analysis [ Time Frame: 52 weeks ]
    laboratory includes haematology, blood chemistry including glucose and potassium, urinalysis, evening plasma cortisol

  14. trough FEV 1 at week 26 [ Time Frame: week 26 ]
    In addition to the comparison QMF149 150/160 µg delivered via Concept1 o.d. (in the evening) to MF 400 µg o.d (in the evening) delivered via Twisthaler® or QMF149 150/320 µg delivered via Concept1 o.d. (in the evening) to MF 800 µg delivered via Twisthaler® (delivered as 400 µg b.i.d.) QMF149 150/320 µg delivered via Concept1 will be compared with salmeterol xinafoate /fluticasone propionate 50/500 µg via Accuhaler® for all the listed secondary endpoints above as well as through FEV 1 at week 26: *Trough FEV1 will be tested for non-inferiority versus salmeterol/fluticasone 50/500 µg. If non-inferiority criteria are met, this will be tested for superiority.

  15. FVC over 52 weeks [ Time Frame: 52 weeks ]
    FVC is the total amount of air exhaled during the FEV test.

  16. FEF over 52 weeks [ Time Frame: 52 weeks ]
    FEF is the Forced Expiratory Flow



Information from the National Library of Medicine

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Ages Eligible for Study:   12 Years to 75 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients with a diagnosis of asthma, for a period of at least 1 year prior to Visit 1 (Screening)
  • Patients who have used medium or high dose ICS or low dose of LABA/ICS combinations for asthma for at least 3 months and at stable doses for at least 1 month prior to Visit 1
  • Patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (prior to double-blind treatment) and qualify for treatment with medium or high dose LABA/ICS
  • Pre-bronchodilator ≥ 50% FEV1 of < 85 % of the predicted normal value for the patient after withholding bronchodilators at both Visit 101 and 102, according to ATS/ERS criteria.
  • Withholding period of bronchodilators prior to spirometry: SABA for ≥ 6 hours and FDC or free combinations of ICS/LABA for ≥ 48 hours, SAMA for ≥ 8 hours, xanthines >=07 days
  • A one-time repeat/re-testing of percent predicted FEV1 (prebronchodilator FEV1) is allowed at Visit 101 and at Visit 102.

Spacer devices are permitted for reversibility testing only.

-Patients who demonstrate an increase in FEV1 of 12% and 200 mL within 30 minutes after administration of 400 µg salbutamol/360 µg albuterol (or equivalent dose) at Visit 101 All patients must perform a reversibility test at Visit 101

If reversibility is not demonstrated at Visit 101:

  • Reversibility should be repeated once-
  • Patients may be permitted to enter the study with historical evidence of reversibility that was performed according to ATS/ERS guidelines within 2 years prior to Visit 1
  • Alternatively, patients may be permitted to enter the study with a historical positive bronchoprovocation test that was performed within 2 years prior to Visit 1.

Exclusion Criteria:

  • Patients who have smoked or inhaled tobacco products within the 6 month period prior to Visit 1, or who have a smoking history of greater than 10 pack years. This includes use of nicotine inhalers such as e-cigarettes at the time of Visit 1
  • Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6 weeks of Visit 1 (Screening)
  • Patients who have ever required intubation for a severe asthma attack/exacerbation.
  • Patients who have a clinical condition which is likely to be worsened by ICS administration (e.g. glaucoma, cataract and fragility fractures) who are according to investigator's medical judgment at risk participating in the study).
  • Patients who have had a respiratory tract infection or asthma worsening as determined by the investigator within 4 weeks prior to Visit 1 (Screening) or between Visit 1 and Visit 102. Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
  • Patients with a history of chronic lung diseases other than asthma, including (but not limited to) COPD, sarcoidosis, interstitial lung disease, cystic fibrosis, clinically significant bronchiectasis and active tuberculosis.
  • Patients with severe narcolepsy and/or insomnia.
  • Patients who have a clinically significant ECG abnormality at Visit 101 (Start of Run- In epoch) and at any time between Visit 101 and Visit 102 (including unscheduled ECG). ECG evidence of myocardial infarction at Visit 101 (via central reader) should be clinically assessed by the investigator with supportivedocumentation
  • Patients with a history of hypersensitivity to lactose, any of the study drugs or to similar drugs within the class including untoward reactions to sympathomimetic amines or inhaled medication or any component thereof
  • Patients who have not achieved an acceptable spirometry results at Visit 101 in accordance with American Thoracic Society/European Respiratory Society (ATS/ERS) criteria for acceptability and repeatability (rescreening allowed only once).

Repeat spirometry may be allowed once in an ad-hoc visit if the spirometry did not qualify due to ATS/ERS criteria. If the patient fails the repeat assessment, the patient may be rescreened once

  • Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
  • Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using highly effective methods of contraception during dosing of study treatment and for 30 days after stopping of study treatment.
  • LAMA use within 3 months prior to Visit 101

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02554786


Contacts
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Contact: Novartis Pharmaceuticals 1-888-669-6682
Contact: Novartis Pharmaceuticals +41613241111

  Show 430 Study Locations
Sponsors and Collaborators
Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02554786     History of Changes
Other Study ID Numbers: CQVM149B2301
2015-002529-21 ( EudraCT Number )
First Posted: September 18, 2015    Key Record Dates
Last Update Posted: March 14, 2019
Last Verified: March 2019

Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QMF149, Mometasone furoate (MF), asthma

Additional relevant MeSH terms:
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Asthma
Lung Diseases, Obstructive
Lung Diseases
Anti-Asthmatic Agents
Bronchial Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Fluticasone
Mometasone Furoate
Salmeterol Xinafoate
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents
Dermatologic Agents
Anti-Allergic Agents
Adrenergic beta-2 Receptor Agonists
Adrenergic beta-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action