Assess bronchodilator effect and safety of two doses of QVM149 compared to a fixed dose combination of salmeterol/fluticasone in patients with Asthma
- Conditions
- AsthmaMedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersTherapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2016-005164-34-GB
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Not specified
- Target Recruitment
- 116
• 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
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
- Secondary Outcome Measures
Name Time Method