asthma chronic lung inflammation
Conditions
Interventions
Sponsors
Novartis Pharma AG
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
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
Exclusion criteria
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary endpoint is the peak FEV1 (mL) defined as t he highest bronchodilatory effect on FEV1 during a period of 5 min to 4 h after the last dose of the preceding 3-week treatment period. Safety: * Physical examination * Vital signs * Laboratory evaluations; hematology, blood chemistry and urinalysis * Electrocardiogram (ECG) | — |
Secondary
| Measure | Time frame |
|---|---|
| Please see page 23 and 24 of the study protocol | — |
Countries
The Netherlands
Outcome results
None listed