Clinical trial NCT03100825: A Long-term Safety Study of QVM149 in Japanese Patients With Asthma
Official title: A Multicenter, Open-label, Single Arm, 52-week Treatment Study to Assess the Safety of QVM149 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: 96
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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 (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

Primary outcomes:
measure: Number of Participants With Treatment Emergent Adverse Events (TEAEs), Serious Adverse Events (SAEs)
timeFrame: Up to 52 Weeks
Secondary outcomes:
measure: Change From Baseline (Pre-dose) Forced Expiratory Volume in One Second (FEV1) at Week 26 and 52
timeFrame: Baseline (Pre-dose), Week 26, Week 52
measure: Change From Baseline (Pre-dose) Forced Vital Capacity (FVC) at Week 26 and 52
timeFrame: Baseline (Pre-dose), Week 26, Week 52
measure: Change From Baseline in Morning and Evening Peak Expiratory Flow (PEF) Over 52 Weeks
timeFrame: Baseline up to week 52
measure: Change From Baseline in Asthma Control Questionnaire-7 (ACQ-7) Total Score at Week 26 and 52
timeFrame: Baseline, Week 26, Week 52
measure: 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
timeFrame: Week 26, Week 52
measure: Change From Baseline in Daily Number of Puffs of Rescue Medication Over 52 Weeks
timeFrame: Baseline up to week 52
Other outcomes:
Locations:
city: Koga city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Yanagawa-city
country: Japan
facility: Novartis Investigative Site
state: Fukuoka
city: Maebashi-shi
country: Japan
facility: Novartis Investigative Site
state: Gunma
city: Hiroshima-city
country: Japan
facility: Novartis Investigative Site
state: Hiroshima
city: Sapporo-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Tomakomai-city
country: Japan
facility: Novartis Investigative Site
state: Hokkaido
city: Takamatsu-city
country: Japan
facility: Novartis Investigative Site
state: Kagawa
city: Fujisawa-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sagamihara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Sagamihara-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokohama-city
country: Japan
facility: Novartis Investigative Site
state: Kanagawa
city: Yokkaichi-city
country: Japan
facility: Novartis Investigative Site
state: Mie
city: Nagaoka-City
country: Japan
facility: Novartis Investigative Site
state: Niigata
city: Osaka city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Sakai-city
country: Japan
facility: Novartis Investigative Site
state: Osaka
city: Ageo-city
country: Japan
facility: Novartis Investigative Site
state: Saitama
city: Chuo ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Chuo-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Ota-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Setagaya-ku
country: Japan
facility: Novartis Investigative Site
state: Tokyo
city: Shinagawa-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: