Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in… (NCT03108027) | Clinical Trial Compass
CompletedPhase 2
Assess Bronchodilator Effect QVM149 Dosed Either in the Morning or Evening Compared to Placebo in Patients With Asthma
Germany38 participantsStarted 2017-06-26
Plain-language summary
This was a randomized, placebo-controlled, double-blind, six-sequence, three-period cross-over study in asthma patients. The study consisted of a 14-day screening period, followed by a 14-day run-in period, and a treatment epoch which consists of three treatment periods, with a minimum duration of 14 days each followed (for the 2 first treatment periods) by a wash-out period. The duration of each treatment period may be extended up to a duration of 18 days if needed for operational reasons. The third treatment period was followed by a Study Completion evaluation at 1-7 days following the last dose. The treatment periods were separated by wash-out periods of 14 to 21 days duration.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
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 μg salbutamol/360 μg 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.
Exclusion Criteria:
* Contraindicated for treatment with, or having a history of reactions/ hypersensitivity t…
What they're measuring
1
FEV1 Standardized Area Under the Curve (AUC 0-24h) After Last Evening Dose of 14-day Treatment Period
Timeframe: At the end of each treatment period day 14 pre-dose to 24 hours post-dose.