Neutrophilic Asthma Study With SCH 527123 (Study P05365AM2)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00632502
First received: February 29, 2008
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

4-Week Safety Study in Subjects with Neutrophilic Asthma


Condition Intervention Phase
Neutrophilic Asthma
Drug: SCH 527123
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Safety of SCH 527123 in Subjects With Neutrophilic Asthma

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

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 ]

Enrollment: 34
Study Start Date: May 2008
Study Completion Date: February 2009
Primary Completion Date: February 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SCH 527123
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 Comparator: Placebo
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00632502     History of Changes
Other Study ID Numbers: P05365, Doc ID: 3709483
Study First Received: February 29, 2008
Last Updated: March 5, 2014
Health Authority: Greece: National Drug Authority

Additional relevant MeSH terms:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on September 29, 2014