Safety of SCH 527123 in Subjects With Neutrophilic Asthma - ND

• Conditions: netrophilic asthma; MedDRA version: 9.1Level: LLTClassification code 10003553Term: Asthma

• Registration Number: EUCTR2007-005615-26-IT
• Lead Sponsor: Schering Plough Research Institute, a division of Schering Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2008-05-06
• Last Update Posted: 7 August 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

The subject must meet ALL the criteria listed below for entry: 1. Subject must be 18 to ≤70 years of age, of either sex, and any race. 2. Subject must have an induced sputum neutrophil count ≥ 40% of total WBCs and <10 million/µL at Screening (Visit 1 assessment). 3. Subject must have a documented diagnosis of asthma (within the past 5 years), which will be determined by at least one of the following: ≥12% and 200 mL improvement in FEV1 post-bronchodilator and/or airway hyperresponsiveness (eg, positive methacholine challenge <8 mg/mL). 4. Subject must be a nonsmoker or previous smoker with a cumulative smoking history of less than 20 pack-years (pack-year = 20 cigarettes smoked daily for 1 year). Previous smokers may not have smoked within 1 year prior to Screening. 5. Subject must not have had an exacerbation of asthma for the 4 weeks prior to Screening and subject must be on a stable medication regimen for asthma for at least 4 weeks prior to Screening. 6. Subject must be receiving >800 mcg/day of beclomethasone dipropionate (BDP) or equivalent for at least 3 months prior to Screening (and on a stable dose for at least 4 weeks prior to Screening). 7. Subject must be willing to give written informed consent to participate in the study. 8. Subject must be capable of complying with the dosing regimen, adhere to the visit schedule, and participate in all treatment procedures, including sputum induction. 9. A female subject of childbearing potential must have a negative serum pregnancy test (hCG) at Screening and must be using a medically acceptable, highly effective, adequate form of birth control (ie, failure rate <1% per year when used consistently and correctly) prior to Screening and agree to continue using it while in the study (Screening and Treatment Periods). Medically acceptable, highly effective forms of birth control are hormonal implants, oral contraceptives, medically acceptable prescribed intrauterine devices (IUDs), and monogamous relationship with a male partner who has had a vasectomy. Female subject who is not of childbearing potential must have a medical record of being surgically sterile (eg, hysterectomy, tubal ligation), or be at least 1 year postmenopausal. Absence of menses for at least 1 year will indicate that a female is postmenopausal. A female subject should be encouraged to continue using a highly effective method of birth control for 30 days following the end of treatment. 10. A male subject must agree to use an adequate form of contraception for the duration of the study and agree to have sexual relations only with women who use a highly effective birth control method.
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Subject Exclusion Criteria The subject will be excluded from entry if ANY of the criteria listed below are met: 1. Subject who has been diagnosed with COPD or any other clinically relevant lung disease, other than asthma (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis). 2. Subject who has an upper or lower respiratory tract infection at Screening or has had one within 4 weeks prior to Screening. 3. Subject who has received any treatment listed in Table 3 more recently than the indicated washout period prior to Screening. 4. Subject who produced an inadequate amount of sputum for evaluation at the Screening Visit (Visit 1) or is known to have difficulty producing sputum. 5. Subjects with a total sputum neutrophil count of over 10 million/ mL at the Screening Visit. 6. Subjects with a PBN count of <2000/microLitro at the Screening Visit (Visit 1). 7. Subject with a post-bronchodilator FEV1 <1L. 8. Subject with allergy/sensitivity to the study drug or its excipients. 9. Woman who is breast-feeding, pregnant, or intends to become pregnant during the study. 10. Subject requiring mechanical ventilation for a respiratory event within 6 months of Screening. 11. Subject with other clinically relevant medical condition(s) (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic) or who is using medication that may interfere with the effect of the study medication. 12. Subject who has used any investigational drug within 30 days of Screening. 13. Subject who is participating in any other clinical study. 14. Subject who is part of the staff personnel directly involved with this study. 15. Subject who is a family member of the investigational study staff.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of this study is to assess the safety of SCH 527123 in subjects with neutrophilic asthma;Secondary Objective: Secondary Objective(s) The secondary objectives of this study are to assess the: Effect of treatment with SCH 527123 on sputum neutrophils (Proof of Activity [POA]). Pharmacokinetics (PK) of SCH 527123. Effect of treatment with SCH 527123 on asthma symptoms, pulmonary function tests (PFTs), quality of life (QOL), electrocardiograms (ECGs), laboratory assessments, and adverse events (AEs) in subjects with neutrophilic asthma.;Primary end point(s): Primary Endpoint: The primary endpoint is safety as defined by the proportion of subjects in each treatment group who maintain a peripheral neutrophil count ≥1500/μL during the 4-week treatment period.