A 12-week, Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel Group, Phase III Study Evaluating the Efficacy and Safety of PT027 Compared to PT008 and PT007 Administered QID in Adults and Children 4 Years of Age or Older with Asthma (DENALI) - DENALI

Bond Avillion 2 Development LP0 sites1,000 target enrollmentMarch 14, 2019

Overview

No summary available.

Registry

who.int

Start Date

March 14, 2019

End Date

TBD

Last Updated

4 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•For inclusion in the study, subjects must fulfill the following criteria within the screening period:
•1\. Able and willing to provide written informed consent or sign age\-appropriate forms; subjects below legal age of consent must have parent(s) or guardian sign the ICF before participation;
•2 .Female or male aged \=4 years at the time of informed consent. In the Czech Republic, Germany, Serbia, Slovakia and Ukraine only subjects \= 18 years will be included.
•3\. Diagnosis of asthma as defined by GINA criteria with a documented history of the last 6 months prior to Visit 1;
•4 Receiving 1 of the following inhaled asthma medications with stable dosing for at least 30 days prior to Visit 1:
•(a) Only SABA used prn
•(b) Stable low\-dose ICS in addition to prn use of SABA
•5\. Pre\-bronchodilator FEV1 of \=50 to \<85% predicted normal value for adults (\=18 years of age) and \=50 % predicted normal value for subjects aged 4 to 17 years after withholding SABA \=6 hours at Visit 1\. If subject took SABA or any bronchodilator in the morning of Visit 1, either the entire visit must be rescheduled or just PFT assessment rescheduled; Subjects 4 to 17 years of age who previously failed inclusion criteria 5
•due to the upper FEV1 limit will be permitted to re\-screen once and will
•be required to meet all eligibility criteria upon re\-screening.

•Subjects must not enter the study if any of the following exclusion criteria are fulfilled within the screening period:
•1\. Chronic obstructive pulmonary disease or other significant lung disease (eg, chronic bronchitis, emphysema, bronchiectasis with the need of treatment, cystic fibrosis, or bronchopulmonary dysplasia);
•2\. Systemic corticosteroids (SCS) use (any dose and any indication) within 3 months before Visit 1;
•3\. Chronic (\=3 weeks) use of SCS within 6 months prior to Visit 1;
•4\. Received any marketed (eg, omalizumab, mepolizumab, reslizumab, benralizumab, dupilumab) or investigational biologic within 3 months or 5 half\-lives before Visit 1, whichever is longer, or any other prohibited medication;
•5\. Current smokers, former smokers with \>10 pack\-years history, or former smokers who stopped smoking \<6 months before Visit 1 (including all forms of tobacco, e\-cigarettes \[vaping], and marijuana);
•6\. Life\-threatening asthma defined as any history of significant asthma episode(s) requiring admission to an intensive care unit, intubation associated with hypercapnia, respiratory arrest, hypoxic seizures, or asthma\-related syncopal episode(s) within 5 years of Visit 1;
•7\. Completed treatment for lower respiratory infection within 6 weeks prior to Visit 1;
•8\. Upper respiratory infection involving antibiotic treatment not resolved within 7 days prior to Visit 1;
•9\. Hospitalizations due to asthma within 6 months prior to Visit 1;