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Neutrophilic Asthma Study With SCH 527123 (Study P05365AM2)
This study is currently recruiting participants.
Verified by Schering-Plough, January 2009
Sponsored by: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00632502
  Purpose

4-Week Safety Study in Subjects with Neutrophilic Asthma


Condition Intervention Phase
Neutrophilic Asthma
Drug: SCH 527123
Drug: Placebo
Phase II

MedlinePlus related topics: Asthma
U.S. FDA Resources
Study Type: Interventional
Study Design: Treatment, Randomized, Double Blind (Subject, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Safety Study
Official Title: Safety of SCH 527123 in Subjects With Neutrophilic Asthma

Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • The primary endpoint is safety. [ Time Frame: Throughout the 4 weeks (Week 5 is a safety follow-up visit) ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Effects of Treatment with SCH 527123: Reducing levels of sputum neutrophils. PK parameters. Asthma symptoms, PFTs, QOL, ECGs, lab assessments, & AEs. [ Time Frame: Data: to be summarized and analyzed at 4 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2008
Estimated Study Completion Date: February 2009
Estimated Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
SCH 527123: Experimental
30 mg capsule, to be taken once daily in the morning
Drug: SCH 527123
30 mg capsule to be taken once daily in the morning for 4 weeks.
Placebo: Placebo Comparator
Placebo capsule to match SCH 527123, to be taken once daily in the morning
Drug: Placebo
Placebo capsule to match SCH 527123 to be taken once daily in the morning for 4 weeks.

Detailed Description:

Effect of treatment with SCH 527123 on sputum neutrophils and asthma symptoms. Pharmacokinetics of SCH 527123.

  Eligibility

Ages Eligible for Study:   18 Years to 70 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 18 to <=70 years of age, either sex, any race.
  • Induced sputum neutrophil count >=40% of total WBCs and <10 million/mL at Screening.
  • Documented diagnosis of asthma (within past 5 years), 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).
  • Nonsmoker or previous smoker with cumulative smoking history 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.
  • Must not have had an exacerbation of asthma for 4 weeks prior to Screening and must be on a stable medication regimen for asthma at least 4 weeks prior to Screening.
  • Must be receiving >=800 mcg/day of beclomethasone dipropionate (BDP) or equivalent for at least 3 months prior to Screening (and on stable dose for at least 4 weeks prior to Screening).
  • Must be willing to give written informed consent to participate in the study
  • Must be capable of complying with the dosing regimen, adhere to the visit schedule, and participate in all treatment procedures, including sputum induction.
  • 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.
  • 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.

Exclusion Criteria:

  • COPD/other relevant lung disease (other than asthma).
  • 4 wks prior to/or Screening: upper/lower respiratory tract infection.
  • Prohibited meds rec'd more recently than indicated washout prior to Screening
  • Screening: Inadequate amt or difficulty producing sputum.
  • Screening: Sputum neutrophil count over 10 million/mL.
  • Screening: PBN count <3000/µL.
  • Post-bronchodilator FEV1 <1L.
  • Subject with clinically significant chronic infectious disease(s) (eg, HIV, hepatitis B or C).
  • Allergy/sensitivity to study drug/excipients.
  • Breast-feeding, pregnant/intends to become pregnant during study.
  • Requiring mechanical ventilation for respiratory event within 6 months of Screening.
  • Medical condition(s) (eg, hematologic, cardiovascular, renal, hepatic, neurologic, or metabolic) or medication that may interfere with effect of study medication.
  • Within 30 days of Screening: any other investigational drug.
  • Participation: any other clinical study.
  • Part of the staff personnel involved with the study.
  • Family member of investigational study staff.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00632502

Contacts
Contact: SP Clinical Trial Registry Call Center 1-888-772-8734

Locations
Canada
Investigational Site 12 Recruiting
Hamilton, Canada, L8N 4A6
Investigational Site 25 Recruiting
Hamilton, Canada, L8N 3Z5
France
Investigational Site 14 Recruiting
Montpellier Cedex 5, France, 34295
Investigational Site 13 Recruiting
Marseille Cedex 9, France, 13274
Germany
Investigational Site 18 Recruiting
Hamburg, Germany, 22291
Greece
Investigational Site 11 Recruiting
Athens, Greece, GR 11527
Italy
Investigational Site 17 Recruiting
Palermo, Italy, 90146
Investigational Site 16 Recruiting
Foggia, Italy, 71100
Sponsors and Collaborators
Schering-Plough
  More Information

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: P05365, Doc ID: 3709483
Study First Received: February 29, 2008
Last Updated: January 28, 2009
ClinicalTrials.gov Identifier: NCT00632502  
Health Authority: Greece: National Drug Authority

Study placed in the following topic categories:
Hypersensitivity
Lung Diseases, Obstructive
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases
Hypersensitivity, Immediate
Asthma
Respiratory Hypersensitivity

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on February 06, 2009