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

February 29, 2008
March 5, 2014
May 2008
February 2009   (final data collection date for primary outcome measure)
The primary endpoint is safety. [ Time Frame: Throughout the 4 weeks (Week 5 is a safety follow-up visit) ] [ Designated as safety issue: Yes ]
The primary endpoint is safety. [ Time Frame: Throughout the 4 weeks ] [ Designated as safety issue: Yes ]
Complete list of historical versions of study NCT00632502 on ClinicalTrials.gov Archive Site
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 ]
Same as current
Not Provided
Not Provided
 
Neutrophilic Asthma Study With SCH 527123 (Study P05365AM2)(COMPLETED)
Safety of SCH 527123 in Subjects With Neutrophilic Asthma

4-Week Safety Study in Subjects with Neutrophilic Asthma

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

Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Neutrophilic Asthma
  • Drug: SCH 527123
    30 mg capsule to be taken once daily in the morning for 4 weeks.
  • Drug: Placebo
    Placebo capsule to match SCH 527123 to be taken once daily in the morning for 4 weeks.
  • Experimental: SCH 527123
    30 mg capsule, to be taken once daily in the morning
    Intervention: Drug: SCH 527123
  • Placebo Comparator: Placebo
    Placebo capsule to match SCH 527123, to be taken once daily in the morning
    Intervention: Drug: Placebo
Nair P, Gaga M, Zervas E, Alagha K, Hargreave FE, O'Byrne PM, Stryszak P, Gann L, Sadeh J, Chanez P; Study Investigators. Safety and efficacy of a CXCR2 antagonist in patients with severe asthma and sputum neutrophils: a randomized, placebo-controlled clinical trial. Clin Exp Allergy. 2012 Jul;42(7):1097-103. doi: 10.1111/j.1365-2222.2012.04014.x.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
34
February 2009
February 2009   (final data collection date for primary outcome measure)

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.
Both
18 Years to 70 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT00632502
P05365, Doc ID: 3709483
Yes
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
Not Provided
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP