NCT02892344CompletedPhase 3
A Multi-center, Randomized, 12-week Treatment, Doubleblind Study to Assess the Efficacy and Safety of QMF149 (150/80 Microgram) Compared With MF Twisthaler® (200 Microgram) in Adult and Adolescent Patients With Asthma
Novartis Pharmaceuticals122 sites in 8 countries802 target enrollmentStarted: January 16, 2017Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Novartis Pharmaceuticals
- Enrollment
- 802
- Locations
- 122
- Primary Endpoint
- Trough FEV1
Study Overview
Brief Summary
The purpose of the trial was to evaluate efficacy and safety of QMF149 150/80 microgram o.d.
delivered via Concept1 compared to MF 200 microgram o.d., delivered via Twisthaler® in terms of lung function and symptom control in poorly (ie inadequately) controlled asthma patients. This study was to assess contribution of LABA as an add-on therapy to low dose ICS monotherapy.
Detailed Description
The primary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. The key secondary objective of this study was to demonstrate the superiority of QMF149 150/80 microgram to MF 200 microgram o.d. in terms of ACQ-7 after 12 weeks of treatment.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Triple (Participant, Care Provider, Investigator)
Eligibility Criteria
- Ages
- 12 Years to 75 Years (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Patients with a documented diagnosis of asthma for a period of at least 3 months prior to Screening Visit
- •Patients who have used low dose ICS , with or without controller (ie, LABA, Leukotriene Receptor Antagonist ) at stable dose for at least 1 month prior to Screening Visit
- •Adult patients who are symptomatic at screening despite treatment with existing therapy.
- •Patients with ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 (inadequately controlled).
- •Adolescent patients :
- •If taking only ICS (without LABA) and are symptomatic at screening despite treatment with low doses of ICS. These patients must have ACQ-7 score ≥ 1.5 at Visit 101 and at Visit 102 .
- •If taking ICS (low dose)/ LABA, and have ACQ-7 score ≥1 and <1.5 at Visit 101: they must have ACQ-7 score≥1.5 at Visit 102 ( prior to randomization).
- •Pre-bronchodilator FEV1≥ 60 % and < 90 % of the predicted normal value for the patient after withholding bronchodilators at both Visits 101 and 102
- •Patients who demonstrate an increase in FEV1 of 12% and ≥ 200 mL within 30 minutes after administration of 400 microgram salbutamol/360 microgram albuterol (or equivalent dose) at Visit 101.
Exclusion Criteria
- •Patients who have smoked or inhaled tobacco products (including electronic cigarettes) within the 6 month period prior to Visit 1, or who have a smoking history of greater than or equal to 10 pack year.
- •Patients who have had an asthma attack/exacerbation requiring systemic steroids or hospitalization (> 24 hours) or emergency room visit (≤ 24 hours) as follows:
- •For adults: within 6 weeks of Screening Visit. If patients experience an asthma attack/exacerbation requiring systemic steroids or emergency room visit between Visit 1 and Visit 102 they may be re-screened 6 weeks after recovery from the exacerbation
- •For adolescents: Severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR hospitalization (> 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids in the last 6 months, OR emergency room visit (≤ 24 hours) due to severe asthma attack/exacerbation requiring systemic corticosteroids within the last 6 months.
- •Patients who ever required intubation for a severe asthma attack/exacerbation
- •Patients with a clinical condition (eg. glaucoma, cataract and fragility fractures) which may be worsened by ICS administration (according to investigator's medical judgment )
- •Patients who have had a respiratory tract infection or asthma worsening within 4 weeks prior to Screening Visit or between Visit 1and Visit
- •Patients may be re-screened 4 weeks after recovery from their respiratory tract infection or asthma worsening.
- •Patients with any chronic conditions affecting the upper respiratory tract (eg. chronic sinusitis) which in the opinion of the investigator may interfere with the study.
- •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 Type I diabetes or uncontrolled Type II diabetes.
- •Patients with narcolepsy and/or insomnia.
- •Patients on Maintenance Immunotherapy (desensitization) for allergies or less than 3 months prior to Visit 101 or patients on Maintenance Immunotherapy for more than 3 months prior to Visit 101 but expected to change throughout the course of the study.
- •Patients with diagnosed rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption or with known intolerance to lactose or milk products.
- •Patients who use a long acting muscarinic antagonist (LAMA) within 3 months prior to Visit 1.
Arms & Interventions
QMF149 150/80 μg
Experimental
QMF149 150/80 microgram o.d. delivered via Concept1
Intervention: QMF149 150/80 μg (Drug)
MF 200 µg
Active Comparator
MF 200 microgram o.d. delivered via Twisthaler®
Intervention: MF 200 μg (Drug)
Outcomes
Primary Outcomes
Trough FEV1
Time Frame: week 12
demonstrate the superiority of QMF149 150/80 microgram o.d. (in the evening) delivered via Concept1 compared with MF 200 microgram o.d. (in the evening) delivered via Twisthaler® in terms of trough FEV1 after 12 weeks of treatment in adults and adolescents. Forced Expiratory Volume in 1 second (FEV1) is the amount of air which can be forcibly exhaled from the lungs in the first second of a forced exhalation, measured by spirometry.
Secondary Outcomes
- Pre-dose FEV1 at Week 4(week 4)
- ACQ-7 at Week 4(week 4)
- ACQ-7(week 12)
- Daily E-diary Over 12 Weeks(week 12)
- Percentage of Rescue Medication Free Days Over 12 Weeks(week 12)
- Trough FEV1 at Day 2(Day 2)
- FVC Over 12 Weeks(week 12)
- The Number of Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period(Week 12)
- Number of Patients With First Asthma Exacerbations (Moderate or Severe) Over the 12 Week Treatment Period(Week 12)
- Percentage of Patients With ACQ-7 MID at Week 12(week 12)
- Rescue Medication Use Over 12 Weeks(week 12)
- Quality of Life Assessed by Asthma Quality of Life Questionnaire AQLQ-S 12(week 12)
- PEF Over 4 and 12 Weeks(week 12)
- Number of Patients With Asthma Exacerbation Over 12 Weeks(Week 12)
Investigators
Study Sites (122)
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