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A Long-term Safety Study of QVM149 in Japanese Patients With Asthma

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03100825
Recruitment Status : Completed
First Posted : April 4, 2017
Last Update Posted : August 26, 2019
Sponsor:
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )

Brief Summary:
The purpose of this study is to provide long term safety data of QVM149 in Japanese patients with asthma for the registration of QVM149 in Japan.

Condition or disease Intervention/treatment Phase
Asthma Drug: QVM149 Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 96 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Multicenter, Open-label, Single Arm, 52-week Treatment Study to Assess the Safety of QVM149 in Japanese Patients With Asthma
Actual Study Start Date : April 28, 2017
Actual Primary Completion Date : September 18, 2018
Actual Study Completion Date : April 8, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Asthma

Arm Intervention/treatment
Experimental: QVM149
All eligible patients take QVM149 150/50/160 μg once daily over 52 weeks.
Drug: QVM149
QVM149 (indacaterol acetate/glycopyrronium bromide/mometasone furoate)
Other Name: QVM149 150/50/160 μg once daily, delivered as powder in hard capsules via Concept1 inhaler




Primary Outcome Measures :
  1. the number of patients who reported treatment emergent adverse events during the 52 weeks of the study [ Time Frame: 52 weeks ]
    The number of participants who experienced treatment emergent adverse events over 52 weeks of treatment


Secondary Outcome Measures :
  1. Trough FEV1 [ Time Frame: 26 and 52 weeks ]
    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. ACQ-7 [ Time Frame: 26 and 52 weeks ]
    ACQ is the Asthma Control Questionnaire (scoring 5 symptoms, FEV1 entered by the investigator and the rescue medication use entered by the patient) validated to evaluate different levels of asthma control

  3. Rescue medication [ Time Frame: 26 and 52 weeks ]
    The mean daily number of puffs of rescue medication use over the first 26 weeks and over the 52 weeks of treatment and the mean change from baseline are summarized.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Written informed consent must be obtained before any assessment is performed.
  • Male and female adult patient ≥ 18 years old.
  • Patients with a diagnosis of persistent asthma (GINA 2016) for a period of at least 1 year prior to Visit 1.
  • Patients who have used medium or high dose of ICS/LABA combinations for asthma for at least 3 months and at stable dose and regimen for at least 4 weeks prior to Visit 1.
  • An ACQ-7 score ≥ 1.5 at Visits 2.
  • Pre-bronchodilator FEV1 of ≥ 40% and ≤ 85% of the predicted normal value for the patient after withholding bronchodilators at Visit 2.

    o Repeating is allowed once only. Repeating of percentage predicted FEV1 should be done in an ad-hoc visit to be scheduled on a date that would provide sufficient time to receive confirmation from the spirometry data central reviewer of the validity of the assessment before Visit 99.

  • Patients must demonstrate reversibility defined as an increase in FEV1 of ≥ 12% and 200 mL within 15 to 30 minutes after administration of 400 µg of salbutamol at Visit 2. Spacer devices are permitted during reversibility testing only. The Investigator or delegate may decide whether or not to use a spacer for the reversibility testing.

    • If reversibility is not proven at Visit 2, patients may be permitted to enter the study with historical evidence of reversibility that was performed within 5 years prior to Visit 1.
    • Alternatively, patients may be permitted to enter the study with a historical positive bronchoprovocation test (defined as a provoked fall in FEV1 of 20% by bronchoconstriction agent e.g., methacholine, histamine) or equivalent test (e.g., astography) that was performed within 5 years prior to Visit 1.
    • If reversibility is not proven at Visit 2 and historical data is not available, reversibility should be repeated once in an ad-hoc visit scheduled as close as possible from the first attempt (but not on the same day).

Exclusion Criteria:

  • Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization or emergency room visit within 6-weeks of Visit 1.
  • 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 with narrow-angle glaucoma, symptomatic benign prostatic hyperplasia (BPH) or bladder-neck obstruction or severe renal impairment or urinary retention. BPH patients who are stable on treatment can be considered.
  • Patients who have had a respiratory tract infection or asthma worsening as determined by investigator within 4 weeks prior to Visit 1 or between Visit 1 and Visit 99. 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
  • Pregnant or nursing (lactating) women
  • Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 30 days after stopping of investigational medication

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): NCT03100825


Locations
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Japan
Novartis Investigative Site
Koga city, Fukuoka, Japan, 811 3195
Novartis Investigative Site
Yanagawa-city, Fukuoka, Japan, 832-0059
Novartis Investigative Site
Maebashi-shi, Gunma, Japan, 371-0054
Novartis Investigative Site
Hiroshima-city, Hiroshima, Japan, 732-0052
Novartis Investigative Site
Sapporo-city, Hokkaido, Japan, 001-0901
Novartis Investigative Site
Tomakomai-city, Hokkaido, Japan, 053-8506
Novartis Investigative Site
Takamatsu-city, Kagawa, Japan, 761-8073
Novartis Investigative Site
Fujisawa-city, Kanagawa, Japan, 251-0041
Novartis Investigative Site
Sagamihara-city, Kanagawa, Japan, 228-8522
Novartis Investigative Site
Sagamihara-city, Kanagawa, Japan, 229-1103
Novartis Investigative Site
Yokohama-city, Kanagawa, Japan, 236 0051
Novartis Investigative Site
Yokkaichi-city, Mie, Japan, 510-8561
Novartis Investigative Site
Nagaoka-City, Niigata, Japan, 940-2085
Novartis Investigative Site
Osaka city, Osaka, Japan, 530 0001
Novartis Investigative Site
Sakai-city, Osaka, Japan, 591 8037
Novartis Investigative Site
Ageo-city, Saitama, Japan, 362-8588
Novartis Investigative Site
Chuo ku, Tokyo, Japan, 103 0027
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 103-0003
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 103-0027
Novartis Investigative Site
Chuo-ku, Tokyo, Japan, 103-0028
Novartis Investigative Site
Ota-ku, Tokyo, Japan, 145 0063
Novartis Investigative Site
Setagaya-ku, Tokyo, Japan, 158-0097
Novartis Investigative Site
Setagaya-ku, Tokyo, Japan, 158-8531
Novartis Investigative Site
Shinagawa-ku, Tokyo, Japan, 142-8666
Novartis Investigative Site
Toshima ku, Tokyo, Japan, 170 0003
Sponsors and Collaborators
Novartis Pharmaceuticals
Investigators
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Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals

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Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03100825     History of Changes
Other Study ID Numbers: CQVM149B1304
First Posted: April 4, 2017    Key Record Dates
Last Update Posted: August 26, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Novartis ( Novartis Pharmaceuticals ):
QVM149,
Asthma,
Japanese,
Allergic asthma,
Allergy triggered asthma,
Reactive asthma,
Asthma attack,
Difficulty breathing
Additional relevant MeSH terms:
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Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases