Assess bronchodilator effect and safety of two doses of QVM149 compared to a fixed dose combination of salmeterol/fluticasone in patients with Asthma

Phase 1

Conditions: Asthma
MedDRA version: 20.0Level: PTClassification code 10003553Term: AsthmaSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

Registration Number: EUCTR2016-005164-34-BG

Lead Sponsor: ovartis Pharma AG

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 114

Inclusion Criteria

• Male and female adult patients = 18 years old and = 75 years.
• Patients with a documented physician diagnosis of asthma for a period of at least 12 months prior to Visit 1 (Screening).
• Patients who have used ICS and LABA combinations for asthma for at least 3 months and at a stable medium or high dose of ICS for at least 1
month prior to Visit 1 (Screening).
• Pre-bronchodilator FEV1 of < 80 % of the predicted normal value at screening Visit 1
(spirometry will not be repeated at baseline prior to randomization).
• Patients who demonstrate an increase in FEV1 of = 12 % and 200 mL after administration of 400 µg salbutamol/360 µg albuterol (or equivalent do se) at
Visit 1 (Screening). All patients must perform a reversibility test at Visit 1 (Screening). If reversibility is not demonstrated at Visit 1 (Screening), then, reversibility testing may be repeated once during the screening period.
• If reversibility is not demonstrated at Visit 1 (retesting allowed once), patients must be screen failed. Spacer devices are not permitted during reversibility testing

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 105
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 9

Exclusion Criteria

Patients who have smoked or inhaled tobacco
products within the 6 month period prior to Visit 1
• Patients who have had an asthma
attack/exacerbation requiring systemic steroids or
hospitalization or emergency room visit within 6
weeks of Visit 1
• Patients with narrow-angle glaucoma,
symptomatic benign prostatic hyperplasia (BPH) or
bladder-neck obstruction or severe renal impairment
or urinary retention
• Patients who have had a respiratory tract
infection or asthma worsening within 4 weeks prior to
Visit 1
• Patients with any chronic conditions affecting the
upper respiratory tract
• 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 (HbA1c >9% at screening).
• Patients who have a clinically significant ECG abnormality at Visit 1
• Patients with a history of hypersensitivity or
intolerance to any of the study drugs (including
excipients)
• Patients with narcolepsy and/or insomnia.
• Patients on Maintenance Immunotherapy
(desensitization) for allergies for less than 3 months
prior to Visit 2 or patients on Maintenance
Immunotherapy for more than 3 months prior to Visit 2
but expected to change throughout the course of the
study.
• Pregnant or nursing (lactating) women
• Women of child-bearing potential must use
Highly effective contraception methods
• Patients who have discontinued LAMA therapy in
the past for any safety, tolerability or perceived lack of
efficacy reason.
• History of paradoxical bronchospasm in
response to inhaled medicines.
• Patients with a history of clinically relevant
bronchoconstriction upon repeated forced expiratory
maneuvers.
• Patient with a serum potassium level below the
laboratory limit of normal at screening.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: •To demonstrate superiority in peak bronchodilator effect of QVM149 at a dose of 150/50/160 µg o.d. and 150/50/80 µg o.d. compared to a FDC of salmeterol/fluticasone at a dose of 50/500 µg b.i.d. after 3 weeks of treatment in patients with asthma;Secondary Objective: •To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment.<br>•To evaluate the bronchodilator effect of each dose of QVM149 compared to salmeterol/ fluticasone FDC by measuring standardized FEV1 AUCs after 3 weeks of treatment respective period.<br>•To evaluate post-dose trough bronchodilator effect of each dose of QVM149 compared to salmeterol/fluticasone FDC after 3 weeks of treatment in the respective treatment period.;Primary end point(s): Peak FEV1 (mL) defined as the highest bronchodilatory effect on FEV1 during a period of 5 min to 4 h after the last evening dose of each treatment period.;Timepoint(s) of evaluation of this end point: 3 weeks

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): • FEV1, Forced Vital Capacity (FVC), and FEV1/FVC ratio at timepoints in relation to evening dose.<br>• FEV1AUC 5 min - 1 h (Day 21), FEV1AUC 5 min - 4 h (Day 21)<br> FEV1AUC 5 min (Day 21) - 23 h 45 min (Day 22)<br>• Trough FEV1 (mL; mean of FEV1 at 23 h 15 min and 23 h 45 min post-dose);Timepoint(s) of evaluation of this end point: 3 weeks

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