NCT03100500

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

Completed Phase 3 Results posted Last updated 7 February 2020

What this trial tests

Phase 3 trial testing QMF149 in Asthma in 51 participants. Completed in 12 February 2019.

Timeline

25 April 2017

Primary endpoint
19 July 2018

12 February 2019

Quick facts

Lead sponsor	Novartis Pharmaceuticals
Phase	Phase 3
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	51
Start date	25 April 2017
Primary completion	19 July 2018
Estimated completion	12 February 2019
Sites	15 locations across Japan

Drugs / interventions tested

• QMF149 — full drug profile →

Conditions studied

• Asthma — all drugs for Asthma →

Sponsor

Novartis Pharmaceuticals — full company profile →

Who can join

18 and older, any sex, with Asthma. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Primary · Up to 52 weeks

A TEAE is any adverse event that started on or after the time of the first inhalation of study drug but not later than 7 days (30 days in the case of a SAE) after the last administration. A SAE is described as any adverse event that leads to death, is life-threatening, results in persistent or significant disability/incapacity, causes or prolongs hospitalization, results in a congenital anomaly, or any other important medical event which is medically significant.

TEAEs

Group	Value	95% CI
QMF-149 150/320 μg	40

SAEs

Group	Value	95% CI
QMF-149 150/320 μg	0

Change From Baseline of Pre-Dose Forced Expiratory Volume in 1 Second (FEV1) Measured After 26 And 52 Weeks Treatment Secondary · Baseline, Weeks 26 and 52

The pre-dose FEV1 was defined as the mean of the pre-dose 45 and 15 min FEV1 values prior to evening dose. 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. A positive change from baseline in FEV1 indicates improvement in lung function.

Baseline

Group	Value	95% CI
QMF-149 150/320 μg	2.1565	± 0.58074

Change at Week 26

Group	Value	95% CI
QMF-149 150/320 μg	0.2417	± 0.26361

Change at Week 52

Group	Value	95% CI
QMF-149 150/320 μg	0.1827	± 0.26627

Change From Baseline of Morning and Evening Peak Expiratory Flow (PEF) During 52 Weeks Treatment Secondary · Baseline up to Week 52

PEF is the greatest airflow rate achieved during forced exhalation with lungs fully inflated. PEF was analyzed separately in the morning and evening using an electronic Peak Flow Meter (ePEF). A positive change from baseline in PEF indicates improvement in lung function.

Baseline, Morning PEF

Group	Value	95% CI
QMF-149 150/320 μg	342.88	± 94.656

Change through Weeks 1-52, Morning PEF

Group	Value	95% CI
QMF-149 150/320 μg	15.49	± 49.089

Baseline, Evening PEF

Group	Value	95% CI
QMF-149 150/320 μg	352.65	± 92.624

Change through Weeks 1-52, Evening PEF

Group	Value	95% CI
QMF-149 150/320 μg	9.34	± 42.685

Change From Baseline of Asthma Control Questionnaire (ACQ-7) After 26 And 52 Weeks Treatment Secondary · Baseline, Weeks 26 and 52

The ACQ-7 is a seven-item disease-specific instrument developed and validated to assess asthma control in participants. It consists of five items to assess symptoms and activity limitations, one question to assess rescue medication use, and one question to assess airway caliber (FEV1% predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question (ques

Baseline

Group	Value	95% CI
QMF-149 150/320 μg	1.983	± 0.5381

Change at Week 26

Group	Value	95% CI
QMF-149 150/320 μg	-0.689	± 0.6268

Change at Week 52

Group	Value	95% CI
QMF-149 150/320 μg	-0.830	± 0.6852

Responder Rate of Participants Achieving the Minimal Important Difference (MID) of ACQ-7 ≥ 0.5 After 26 And 52 Weeks Treatment Secondary · Weeks 26 and 52

The ACQ-7 is a seven-item disease-specific instrument developed and validated to assess asthma control in participants. It consists of five items to assess symptoms and activity limitations, one question to assess rescue medication use, and one question to assess airway caliber (FEV1% predicted). All seven items are scored on a 7-point Likert scale, with 0 indicating total control and 6 indicating poor control. The questions are equally weighted and the total score is the mean of the seven items. The first 6 questions of the ACQ-7 were completed by the participant while the last question (ques

Week 26

Group	Value	95% CI
QMF-149 150/320 μg	66.0

Week 52

Group	Value	95% CI
QMF-149 150/320 μg	72.9

Change From Baseline of Rescue Medication Use During 52 Weeks Treatment Secondary · Baseline up to Week 52

Based on the electronic-diary data, the total number of puffs of rescue medication per day over the 52 weeks were calculated and divided by the total number of days to derive the mean daily number of puffs of rescue medication taken for the participant.

Baseline

Group	Value	95% CI
QMF-149 150/320 μg	0.56	± 1.382

Change through Weeks 1-52

Group	Value	95% CI
QMF-149 150/320 μg	-0.18	± 0.499

Adverse events — posted to ClinicalTrials.gov

Time frame: Up to 52 weeks. Reporting threshold: 2%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

QMF149 150/320 µg

Serious: 0/51 (0%)

Deaths: 0/51

Other adverse events (11 terms — click to expand)

Reaction	System	QMF149 150/320 µg
Asthma	Respiratory, thoracic and mediastinal disorders	—
Nasopharyngitis	Infections and infestations	—
Bronchitis	Infections and infestations	—
Upper respiratory tract infection bacterial	Infections and infestations	—
Back pain	Musculoskeletal and connective tissue disorders	—
Myalgia	Musculoskeletal and connective tissue disorders	—
Gastritis	Gastrointestinal disorders	—
Otitis media	Infections and infestations	—
Pharyngitis	Infections and infestations	—
Electrocardiogram QT prolonged	Investigations	—
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	—

Data from ClinicalTrials.gov NCT03100500 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.