Clinical trial NCT03063086 (phase 2, status: completed)
Conditions: asthma
ICD codes: J45.998, J82.83, J45.909, J45.991, J45.20, J45.30, J45.40
Drugs: qvm149 150/50/80 μg o.d., qvm149 150/50/160 μg o.d., salmeterol/fluticasone fdc 50/500 μg b.i.d.
SMILES: OCC1=C(O)C=CC(=C1)C(O)CNCCCCCCOCCCCC1=CC=CC=C1
Eligibility criteria:

        Key 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 month 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
             Key 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.