Assess efficacy and safety of QVM149 administered once daily in the morning or in the evening during 14 days versus placebo in patients with asthma

Phase 1

• Conditions: Asthma; MedDRA version: 20.0 Level: PT Classification code 10003553 Term: Asthma System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2017-000644-17-DE
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-26
• Study Completion: 2018-02-24
• Last Update Posted: 28 February 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 37

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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 31
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range 5

Exclusion Criteria

- 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 clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: This study is to assess the bronchodilator effects of QVM149 dosed once daily either in the morning or in the evening for 2 weeks compared to placebo. ;<br> Secondary Objective: - FEV1 after 24h at the end of each treatment period day 14 pre-dose to 24 hours post-dose<br> - Peak expiratory flow from treatment period start through study completion<br> ;Primary end point(s): FEV1 over 24 h (AUC0-24h) ;Timepoint(s) of evaluation of this end point: Over 24 h (AUC0-24h) following 14 days of treatment with QVM149 dosed in the morning, QVM149 dosed in the evening and placebo.

Secondary Outcome Measures

Name	Time	Method
<br> Secondary end point(s): - FEV1 after 24h <br> - Peak expiratory Flow<br> ;<br> Timepoint(s) of evaluation of this end point: •FEV1 at approximately 24 h after the last p.m. or second last a.m. dose.<br> •PEF: Daily morning and evening peak expiratory flow rate from Day 2 to Day 14 during the three treatment periods<br>