A randomized, double-blind, repeat dose cross-over study<br>to assess the bronchodilator effects of once daily QVM149<br>following morning or evening dosing for 14 days compared<br>to placebo in patients with asthma
- Conditions
- asthmachronic lung inflammation10006436
- Registration Number
- NL-OMON44320
- Lead Sponsor
- ovartis
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 20
Patients with a documented physician diagnosis of asthma and who
additionally meet the following criteria:
* patients receiving daily treatment with an inhaled corticosteroid
at a low or medium daily dose
* on a stable regimen for at least 4 weeks prior to screening.
* Pre-bronchodilator FEV1 * 60 % and < 100% of the predicted normal
value for the patient during screening.
* Patients who demonstrate an increase in FEV1 of * 12 % and * 200 mL
after administration of 400 *g salbutamol/360 *g albuterol (or
equivalent dose) at Screening. All patients must perform a reversibility
test at Screening.
* At screening, and baseline (day 1 pre-dose time) of the first treatment
period, vital signs (systolic and diastolic blood pressure and pulse rate)
will be assessed in the sitting position and again in the standing position
as outlined in the SOM. Sitting and standing vital signs should be within
the following ranges:
* oral body temperature between 35.0-37.5 °C
* systolic blood pressure, 90-159 mmHg
* diastolic blood pressure, 50-99 mmHg
* pulse rate, 40-90 bpm
* Hypertensive patients must have been on stable antihypertensive therapy
for at least 4 weeks prior to screening to be included in the trial.
* Patients must weigh at least 50 kg at screening to participate in the
study, and must have a body mass index (BMI) within the range of 18 to
40 kg/m2.
* Contraindicated for treatment with, or having a history of reactions/
hypersensitivity to any of the drugs of a similar class
* Patients who have had an asthma attack/exacerbation requiring systemic
steroids or hospitalization or emergency room visit within 1 year of
Screening.
* Patients who have had previous intubation for a severe asthma
attack/exacerbation.
* Patients with a history of clinically relevant bronchoconstriction upon
repeated forced expiratory maneuvers.
* History of paradoxical bronchospasm in response to inhaled medicines.
* Patients who during the run-in period prior to randomization require the
use of *12 puffs / 24 hours of rescue medication for 48 hours (over two
consecutive days) or who have a decline in PEF from the reference PEF
of * 30% for 6 consecutive scheduled PEF readings
* Patients who do not maintain regular day/night, waking/sleeping cycles
(e.g., night shift workers).
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>To investigate the potential influence of time of dosing (morning or evening)<br /><br>on the bronchodilator effect of once daily orally inhaled QVM149 compared to<br /><br>placebo.</p><br>
- Secondary Outcome Measures
Name Time Method <p>* To investigate the potential influence of time of dosing (morning or<br /><br>evening) on trough FEV1 of once daily orally inhaled QVM149 compared<br /><br>to placebo.<br /><br>* To investigate the potential influence of time of dosing (morning or<br /><br>evening), on peak expiratory flow rate (PEF) of once daily orally inhaled<br /><br>QVM149 compared to placebo.<br /><br>* To evaluate safety and tolerability of QVM149 when dosed in the<br /><br>morning or in the evening in patients with asthma after during two weeks<br /><br>of treatment in each treatment period.</p><br>