A randomized, double-blind, double-dummy, activecontrolled, 3-period complete cross-over study to assess the bronchodilator effect and safety of two doses of QVM149 compared to a fixed dose combination of salmeterol/fluticasone in patients with asthma.
- Conditions
- asthmachronic lung inflammation10006436
- Registration Number
- NL-OMON47676
- Lead Sponsor
- ovartis Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 10
* 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 *g salbutamol/360 *g
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.
**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
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>The primary endpoint is the peak FEV1 (mL) defined as t he highest<br /><br>bronchodilatory effect on FEV1 during a period of 5 min to 4 h after the last<br /><br>dose of the preceding 3-week treatment period.<br /><br><br /><br>Safety:<br /><br><br /><br>* Physical examination<br /><br>* Vital signs<br /><br>* Laboratory evaluations; hematology, blood chemistry and urinalysis<br /><br>* Electrocardiogram (ECG)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Please see page 23 and 24 of the study protocol</p><br>