Multicenter, Randomized, Double-blind, Placebo-controlled Clinical Trial to Assess Efficacy, Safety and Optimal Dose of XC8 in Patients With Partly Controlled Bronchial Asthma Receiving Stable Treatment With Low Doses of Inhaled Corticosteroids With or Without Long-acting beta2-agonists
Overview
- Phase
- Phase 2
- Intervention
- XC8 Oral Tablet
- Conditions
- Bronchial Asthma
- Sponsor
- PHARMENTERPRISES LLC
- Enrollment
- 120
- Locations
- 12
- Primary Endpoint
- Change in Forced expiratory volume in 1 second (FEV1) in % of predicted value
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
A multicenter, double-blind, randomized, parallel-group comparative Phase II clinical study to assess the efficacy and safety of different doses of XC8 vs Placebo in patients with partly controlled bronchial asthma receiving stable treatment with low doses of inhaled corticosteroids with or without long-acting beta2-agonists during 12-weeks treatment period.
Study design was developed by Pharmenterprises LLS, Russia in cooperation with Eurrus Biotech GmbH, Austria and FGK Clinical Research GmbH, Germany.
The primary objective of the study was to evaluate the effect of different doses of XC8 on change in pre-bronchodilator forced expiratory volume in 1 second (FEV1) (% of predicted value) at Week 12 as compared to baseline at Week 0 vs. Placebo in patients with partly controlled bronchial asthma (BA).
Detailed Description
Twenty Russian centers were approved for participation in this study. Twelve centers were initiated. Patients were enrolled in 12 centers. The study consisted of 4 periods: Screening, Run-In Period, Treatment Period, and Follow-up. All eligible patients were randomized into one of four treatment groups in a ratio of 1:1:1:1. Treatment group of XC8 2 mg daily (30 patients) Treatment group of XC8 10 mg daily (30 patients) Treatment group of XC8 100 mg daily (30 patients) Treatment group of Placebo (30 patients) The study drug was manufactured by order Pharmenterprises LLS, Russia and Eurrus Biotech GmbH, Austria. During the treatment period (12 weeks) patients took the study drug or Placebo once a day in addition to stable low doses of Inhaled Corticosteroids (ICS) with or without long-acting beta2-agonists (LABA). The follow-up period lasted for 4 weeks.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Signed the informed consent.
- •Non-smoking men and women aged from 18 to 65 (inclusively).
- •Diagnosis of bronchial asthma that was established not later than 12 months before screening (with mandatory documented evaluation of reversibility of bronchial obstruction assessed by pre- and post-bronchodilator spirometry).
- •Stable therapy with low doses of inhaled corticosteroids with or without long-acting beta2-agonists for at least 3 months prior to screening (Step 2 and 3 according to GINA, 2015 guideline)
- •Symptoms of partly controlled bronchial asthma during four weeks before screening (accordingly to GINA, 2015)
- •Pre-bronchodilator FEV1 is 60-80% of predicted values (inclusive) \*
- •Consent of patient to use adequate methods of contraception throughout the study. The adequate methods of contraception are as follows:
- •Oral or transdermal contraceptives;
- •Condom or diaphragm (barrier method) with spermicide, or
- •Intrauterine device.
Exclusion Criteria
- •Pregnant or lactating women or women planning pregnancy during the clinical trial; women of childbearing potential (including not sterilized operatively and in postmenopausal period less than 2 years), not using appropriate methods of contraception
- •Smoking within 1 year prior to screening; smoking history of more than 10 pack-year
- •Severe exacerbations or not controlled bronchial asthma for 3 months before screening
- •Chronic Obstructive Pulmonary Disease (COPD) or other lung diseases in addition to bronchial asthma.
- •Inflammatory diseases of mouth
- •Acute infection within 30 days of screening
- •Participation in any clinical trial or use of any investigational product within 30 days of screening
- •Use or indication to take other drugs for treatment of asthma (including antileukotrienes and theophylline extended release), except those permitted by the Protocol
- •Indication for long-term administration of systemic steroidal or non-steroidal anti-inflammatory agents or agents affecting the immune system
- •The need of periodical administration of antihistamines (stable doses of antihistamines for at least 1 month prior to screening and throughout the trial is allowed)
Arms & Interventions
XC8 2 mg
XC8 2mg orally
Intervention: XC8 Oral Tablet
XC8 10 mg
XC8 10 mg orally
Intervention: XC8 Oral Tablet
XC8 100 mg
XC8 100 mg orally
Intervention: XC8 Oral Tablet
Placebo
Placebo 2 mg, 10 mg or 100 mg orally
Intervention: Placebo Oral Tablet
Outcomes
Primary Outcomes
Change in Forced expiratory volume in 1 second (FEV1) in % of predicted value
Time Frame: Week 0 - Week 12
To assess changes in FEV1 measured in % through spirometry testing
Secondary Outcomes
- Rate of severe exacerbations of BA(Week 0 - Week 12)
- Change of serum IgE level(Week 0 - Week 12)
- Change in FEV1/FVC in % of predicted(Week 0 - Week 12)
- Change in frequency of using short-acting β2-agonists(Week 0 - Week 12)
- Proportion of patients with adequate BA control(Week 6 and Week 12)
- Change of eosinophils level in blood and sputum(Week 0 - Week 12)
- Number of Adverse events and Serious adverse event(Week 0 - Week 12)
- Change in Forced expiratory volume in 1 second (FEV1) in absolute values(Week 0 - Week 12)
- Change of serum IgG level(Week 0 - Week 12)
- Change in Peak expiratory flow rate(Week 0 - Week 12)
- Change in FVC in % of predicted(Week 0 - Week 12)
- Change in FEF 25-75% in % of predicted(Week 0 - Week 12)
- Change of serum eosinophil cationic protein level(Screening - Week 0 - Week 12)
- Change of serum tryptase level(Screening - Week 0 - Week 12)