Clinical Trials List
2017-12-01 - 2019-12-31
Phase III
Terminated7
ICD-10J45
Asthma
Multi-center, partially blinded, randomized, 24-week, parallel grouping, non-inferiority, open-label, active controlled trial, comparing the efficacy and safety of QVM149 with salmeterol/fluticasone + tiotropium triple combination therapy for patients with poorly controlled asthma
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Trial Applicant
NOVARTIS (TAIWAN) CO., LTD.
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Sponsor
Norvatis
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Trial scale
Multi-Regional Multi-Center
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Update
2025/08/20
Investigators and Locations
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Co-Principal Investigator
Audit
None
Co-Principal Investigator
The Actual Total Number of Participants Enrolled
1 Terminated
Audit
CRO
Taiwan National PI
Co-Principal Investigator
- 柯皓文 無
- Chih-Liang Wang 無
- Shih-Wei Lin 無
- 莊立邦 無
- Shih-Hong Li 無
- 林定佑 無
- 羅友倫 無
The Actual Total Number of Participants Enrolled
0 Terminated
Audit
None
Co-Principal Investigator
Audit
None
Co-Principal Investigator
- Inn-Wen Chong 無
- 陳家閔 無
- Jen-Yu Hung 無
- Ming-Ju Tsai 無
The Actual Total Number of Participants Enrolled
0 Terminated
The Actual Total Number of Participants Enrolled
0 Terminated
Condition/Disease
Objectives
Test Drug
Active Ingredient
Dosage Form
Inhalation powder in hard capsule
Dosage
150/50/80; 150/50/160
Endpoints
After 24 weeks of treatment, the change in the total score of the Asthma Quality of Life Questionnaire (AQLQ) from the baseline.
2. Secondary evaluation indicators:
-After 24 weeks of treatment, the change in the lowest value of FEV1 from the reference point
-The change in the total score of the Asthma Control Questionnaire (ACQ-7) from the baseline during the 24-week treatment period
-The change in the total score of the Asthma Quality of Life Questionnaire (AQLQ) from the baseline during the 24-week treatment period.
Inclution Criteria
1. Before conducting any trial-related evaluations, the subject signing procedure must be completed. Only patients who are legally fully autonomous can be included (patients who cannot agree on their own cannot be included in this trial)
2. Male and female adult patients over 18 years of age. (Taiwan only accepts adult patients over 20 years old)
3. Patients who were diagnosed with asthma for at least 6 months before the first outpatient clinic, and whose current asthma severity requires treatment with level 4 or higher (2017 GINA guidelines).
4. Patients who have used inhaled steroid/long-acting beta agonist combined therapy to treat asthma for at least 3 months, and have used medium and high-dose inhaled steroids/long-acting beta agonist for at least 3 months before the first outpatient clinic 1 month.
5. Patients must have asthma symptoms at the time of screening, that is, at the 101st return visit and the 201st return visit (randomly assigned return visit), although they have been treated with medium and high doses of inhaled steroids/long-acting beta agonists, the patient's ACQ-7 The score is still up to≥1.5.
6. The patient had at least one acute exacerbation of severe asthma in the 12 months before the first outpatient clinic, requiring doctor's diagnosis and treatment, emergency (or local institution with equivalent function) or hospitalization, and received systemic corticosteroid therapy for at least 3 days ( Including self-management treatment under the guidance of physicians, and oral corticosteroids are part of the written asthma treatment plan).
-The previous acute exacerbation of severe asthma must be supported by documents (for example: source records, pharmacy records, hospital records or medical records): due to worsening asthma symptoms, the accident requires primary physicians, thoracic physicians, emergency department Departments, hospitals, medical care, and the need for systemic corticosteroid treatment due to acute exacerbation of severe asthma, including self-management treatment under the guidance of physicians, and oral corticosteroids in the written asthma action plan.
7. For patients who stopped bronchodilators before the 101st return visit and the 201st return visit to the spirometer, the FEV1 before bronchodilator use was lower than 85% of the expected normal value.
-Repeat testing can be performed at each visit (re-arrange the visit time). If you want to repeat the 101st visit, sufficient time must be reserved on the scheduled date so that the centrally reviewed spirometer test confirmation result can be obtained before random assignment.
-If the patient does not meet the inclusion criteria at the follow-up visit, it can be re-screened.
8. At the 101st visit, after 15 to 30 minutes of using 400 μg salbutamol or 360 μg albuterol (equivalent dose) through an inhalation aid, FEV1 increased by ≥12% and increased by 200 mL. Patients must have a positive reversibility test at the 101st visit, or have a medical record showing that they have had a positive reversibility test or bronchial provocation test according to the ATS/ERS guidelines within 5 years before the first visit . If the patient fails to confirm the existence of reversibility at the 101st visit, the reversibility test needs to be repeated again.
If the patient's reversibility test at the 101st visit (or after repeated visits) does not show reversibility, and there is no evidence of reversibility in the past (or related tests were not performed according to the ATS/ERS guidelines), the screening is deemed to have failed.
Exclusion Criteria
1. The patient has a smoking history of more than 20 pack years (the average number of packs smoked per day multiplied by the number of years of smoking age).
2. Patients who are diagnosed with chronic obstructive pulmonary disease (COPD).
3. Patients who need systemic steroid therapy, hospitalization or emergency medical treatment due to asthma attack/acute exacerbation within 6 weeks before the first outpatient clinic (screening period). Between the first outpatient visit and the 201st return visit, if the patient needs systemic steroid therapy, hospitalization or emergency medical treatment due to an asthma attack/acute exacerbation, the screening can be repeated after 6 weeks of recovery.
4. Patients who have needed intubation therapy due to severe asthma attacks/acute exacerbations.
5. Within 3 months before the first outpatient visit, had received LAMA for asthma.
6. According to the trial host's judgment, within 4 weeks before the first outpatient visit or between the first outpatient visit and the 201st return visit, patients with respiratory tract infection or clinically significantly worsening asthma.
The Estimated Number of Participants
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Taiwan
30 participants
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Global
1500 participants
