A Long-term Safety Study of QMF149 in Japanese Participants With Asthma

NCT ID: NCT03100500

Last Updated: 2020-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 51 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-04-25
• Study Completion Date: 2019-02-12

Brief Summary

The purpose of this study was to provide long term safety data of QMF149 in Japanese participants with inadequately controlled asthma for the registration of QMF149 in Japan.

Conditions

Asthma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

QMF149

All eligible patients take QMF149 150/320 μg once daily over 52 weeks.

Group Type: EXPERIMENTAL

QMF149

Intervention Type: DRUG

QMF149 150/320 μg once daily, delivered as powder in hard capsules via Concept1 inhaler

Interventions

QMF149

QMF149 150/320 μg once daily, delivered as powder in hard capsules via Concept1 inhaler

Intervention Type: DRUG

Eligibility 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 for a period of at least 1 year prior to Visit 1.
• Patients who have used medium or high dose inhaled corticosteroids (ICS) plus at least 1 controller for asthma for at least 3 months and at stable dose and regimen for at least 4 weeks prior to Visit 1.
• Patients must have Asthma Control Questionnaire-7 (ACQ-7) score ≥ 1.5 at Visits 2 and qualify for treatment with high dose ICS/long-acting β2 agonist (LABA).
• Pre-bronchodilator Forced Expiratory Volume in 1 second (FEV1) of ≥ 50% and ≤ 85% of the predicted normal value for the patient after withholding bronchodilators at Visit 2.
• 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.
• Where patient is assessed as eligible based on historical evidence, a copy of the original printed report must be available as source documentation.
• 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).
• If reversibility is not demonstrated at Visit 2 (or after repeated assessment at ad-hoc visit) and historical evidence of reversibility/bronchoprovocation/astography is not available, patients must be screen failed.

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 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) chronic obstructive pulmonary disease, 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Novartis Pharmaceuticals

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Novartis Pharmaceuticals

Role: STUDY_DIRECTOR

Novartis Pharmaceuticals

Locations

Novartis Investigative Site

Nagoya, Aichi-ken, Japan

Novartis Investigative Site

Fukuoka, Fukuoka, Japan

Novartis Investigative Site

Chitose, Hokkaido, Japan

Novartis Investigative Site

Kitahiroshima, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Sapporo, Hokkaido, Japan

Novartis Investigative Site

Takamatsu, Kagawa-ken, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Yokohama, Kanagawa, Japan

Novartis Investigative Site

Yokosuka, Kanagawa, Japan

Novartis Investigative Site

Chino, Nagano, Japan

Novartis Investigative Site

Higashiosaka, Osaka, Japan

Novartis Investigative Site

Chuo Ku, Tokyo, Japan

Novartis Investigative Site

Chuo-ku, Tokyo, Japan

Novartis Investigative Site

Toshima-ku, Tokyo, Japan

Countries

Japan

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

CQVM149B1305

Identifier Type: -

Identifier Source: org_study_id