Clinical trial NCT03100500: A Long-term Safety Study of QMF149 in Japanese Participants With Asthma
Official title: A Multicenter, Open-label, Single Arm, 52-week Treatment Study to Assess the Safety of QMF149 in Japanese Patients With Asthma
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Asthma
Keywords: QVM149,
Asthma,
Japanese,
Allergic asthma,
Allergy triggered asthma,
Reactive asthma,
Asthma attack,
Difficulty breathing
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2017-04-04
Enrollment: 51
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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.

Primary outcomes:
measure: Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Up to 52 weeks
Secondary outcomes:
measure: Change From Baseline of Pre-Dose Forced Expiratory Volume in 1 Second (FEV1) Measured After 26 And 52 Weeks Treatment
timeFrame: Baseline, Weeks 26 and 52
measure: Change From Baseline of Morning and Evening Peak Expiratory Flow (PEF) During 52 Weeks Treatment
timeFrame: Baseline up to Week 52
measure: Change From Baseline of Asthma Control Questionnaire (ACQ-7) After 26 And 52 Weeks Treatment
timeFrame: Baseline, Weeks 26 and 52
measure: Responder Rate of Participants Achieving the Minimal Important Difference (MID) of ACQ-7 ≥ 0.5 After 26 And 52 Weeks Treatment
timeFrame: Weeks 26 and 52
measure: Change From Baseline of Rescue Medication Use During 52 Weeks Treatment
timeFrame: Baseline up to Week 52
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Novartis Investigative Site
state: Aichi
city: Fukuoka-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Chitose-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Kitahiroshima
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Takamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokosuka
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Chino-city
country: Japan
facility: Novartis Investigative Site
state: Nagano
city: Higashiosaka-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Toshima-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References: