Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

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
Results First Posted : April 7, 2020
Last Update Posted : April 7, 2020
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

Layout table for study information
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. Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs) [ Time Frame: Up to 52 Weeks ]
    An adverse event (AE) was any untoward medical occurrence (example; any unfavorable and unintended sign including abnormal laboratory findings, symptom or disease) in a participant or clinical investigation participant after providing written informed consent for participation in the study until the end of study visit. TEAEs were defined as adverse events started on or after the time of the first inhalation of study drug but no later than 7 days after the last administration (30 days in the case of SAEs). SAE was defined as any adverse event (appearance of [or worsening of any pre-existing]) undesirable sign, symptom or medical conditions which is fatal or life-threatening or results in persistent or significant disability/incapacity or constitutes a congenital anomaly/birth defect or requires inpatient hospitalization or prolongation of existing hospitalization or is medically significant.


Secondary Outcome Measures :
  1. Change From Baseline (Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 26 and 52 [ Time Frame: Baseline (Pre-dose), Week 26, Week 52 ]
    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. Change from baseline in FEV1 at week 26 and 52 was reported.

  2. Change From Baseline (Pre-dose) Forced Vital Capacity (FVC) at Week 26 and 52 [ Time Frame: Baseline (Pre-dose), Week 26, Week 52 ]
    Forced Vital Capacity is the amount of air which can be forcibly exhaled from the lungs after taking the deepest breath possible. FVC was assessed by spirometry. Change from baseline in FVC at week 26 and 52 was reported.

  3. Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Over 52 Weeks [ Time Frame: Baseline up to week 52 ]
    PEF is the peak expiratory flow, the maximum speed of expiration. Electronic peak flow meter (ePEF) was given to each participant at visit 1 for the measurement of morning and evening PEF. Change from baseline in morning and evening PEF over 52 weeks was measured.

  4. Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 26 and 52 [ Time Frame: Baseline, Week 26, Week 52 ]
    ACQ-7 is a 7-item, disease-specific instrument developed and validated to assess asthma control in participants. All 7 items were scored on a 7-point Likert scale, with 0 indicating total control of asthma and 6 indicating poor control of asthma. The questions were equally weighted and the total score is the mean of the 7 items. A decrease of ACQ-7 score of at least 0.5 from baseline was considered to be clinically meaningful improvement.

  5. Proportion of Participants Who Achieved Clinically Meaningful Improvement Threshold in ACQ-7 Score (Decrease of Greater Than or Equal to 0.5 Units in ACQ-7) at Week 26 and 52 [ Time Frame: Week 26, Week 52 ]
    ACQ-7 is a 7-item, disease-specific instrument developed and validated to assess asthma control in participants. All 7 items were scored on a 7-point likert scale, with 0 indicating total control of asthma and 6 indicating poor control of asthma. Questions were equally weighted and total score is mean of 7 items. A decrease from baseline of at least 0.5 units in ACQ-7 score was considered to be clinically meaningful improvement. The proportion of participants achieving the clinically meaningful improvement threshold in ACQ-7 score were reported at Week 26 and Week 52.

  6. Change From Baseline in Daily Number of Puffs of Rescue Medication Over 52 Weeks [ Time Frame: Baseline up to week 52 ]
    Daily use of rescue medication (number of puffs taken in the previous 12 hours) were recorded each morning and evening throughout the 52 week treatment by the participant using their electronic diary.



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location information
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, 104-0031
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
Layout table for investigator information
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  Study Documents (Full-Text)

Documents provided by Novartis ( Novartis Pharmaceuticals ):
Study Protocol  [PDF] April 6, 2017
Statistical Analysis Plan  [PDF] April 6, 2017

Layout table for additonal information
Responsible Party: Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT03100825    
Other Study ID Numbers: CQVM149B1304
First Posted: April 4, 2017    Key Record Dates
Results First Posted: April 7, 2020
Last Update Posted: April 7, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description:

Novartis is committed to sharing access to patient-level data and supporting clinical documents from eligible studies with qualified external researchers. Requests are reviewed and approved by an independent review panel on the basis of scientific merit. All data provided is anonymized to protect the privacy of patients who have participated in the trial in line with applicable laws and regulations.

This trial data availability is according to the criteria and process described on www.clinicalstudydatarequest.com


Layout table for additional information
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:
Layout table for MeSH terms
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases