Efficacy and Safety of SCH 527123 in Subjects With Allergen-Induced Asthma (Study P05363)(COMPLETED)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00688467
First received: May 29, 2008
Last updated: March 5, 2014
Last verified: March 2014
  Purpose

Evaluation of treatment in subjects with mild asthma.


Condition Intervention Phase
Asthma
Drug: SCH 527123
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Double-Blind, Placebo-Controlled, Crossover Study to Evaluate the Efficacy and Safety of SCH 527123 in Subjects With Allergen-Induced Asthma

Resource links provided by NLM:


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

Primary Outcome Measures:
  • LAR area under the curve from 3 to 7 hours (AUC(3-7 hr)) expressed as % change in FEV1 from the prechallenge value of FEV1 taken from 3 to 7 hours postallergen challenge, following 9 days pretreatment with SCH 527123. [ Time Frame: Visits 9 and 14 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Maximum percent fall in FEV1 during the late response following 9 days of pretreatment with SCH 527123. [ Time Frame: Visits 9 and 14 ] [ Designated as safety issue: Yes ]
  • LAR AUC(3-7 hr), expressed as actual change in FEV1 from preallergen FEV1 taken from 3 to 7 hours postallergen challenge, following 9 days of pretreatment with SCH 527123. [ Time Frame: Visits 9 and 14 ] [ Designated as safety issue: Yes ]
  • Changes in airway responsiveness as measured by methacholine PC20 24 hours postallergen challenge. [ Time Frame: Visits 9 and 14 ] [ Designated as safety issue: Yes ]
  • Reduction in sputum neutrophils and eosinophils at 7 and 24 hours postallergen challenge. [ Time Frame: Visits 9 and 14 ] [ Designated as safety issue: Yes ]
  • Attenuation of EAR (maximum percent fall in FEV1 from preallergen FEV1 0-2 hours postchallenge) and EAR UC(0-2 hr) following 9 days of pretreatment with SCH 527123. [ Time Frame: Visits 9 and 14 ] [ Designated as safety issue: Yes ]
  • Changes in interleukin 8 (IL-8), myeloperoxidase (MPO), neutrophil elastase, and eosinophil cationic protein (ECP) levels in sputum at 7 and 24 hours postallergen challenge. [ Time Frame: Visits 9 and 14 ] [ Designated as safety issue: Yes ]
  • Safety and tolerability as measured by peripheral neutrophil counts, asthma symptoms, frequency of use of rescue medication, PFTs, ECGs, labs, and AEs. [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]

Enrollment: 18
Study Start Date: June 2008
Study Completion Date: March 2009
Primary Completion Date: March 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 10 days during Treatment Period 1 and 10 days during Treatment Period 2.
Other Name: 30 mg capsule, to be taken once daily in the morning.
Placebo Comparator: Placebo
Placebo capsule to match SCH 527123, to be taken once daily in the morning
Drug: SCH 527123
30 mg capsule to be taken once daily in the morning for 10 days during Treatment Period 1 and 10 days during Treatment Period 2.
Other Name: Placebo capsule to match SCH 527123 to be taken once daily in the morning.

Detailed Description:

To evaluate the effect of SCH 527123 treatment on allergen-induced late asthmatic response (LAR) in subjects with mild asthma.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Subjects must be men and women 18 to 65 years of age of any race.
  • Subjects must have mild, stable, allergic asthma as defined by ATS criteria.
  • Subjects must have history of episodic wheezing and shortness of breath.
  • Subjects must have FEV1 of at least 70% of predicted at Screening and within 10% of preallergen screening value at both baselines.
  • Subjects must have positive methacholine challenge at Screening. Methacholine challenges are considered positive if decreases of at least 20% in the FEV1 occur at a concentration of less than or equal to 16 mg/mL.
  • Subjects' Baseline methacholine PC20 must be within 1 doubling concentration of the preallergen screening PC20 to enter treatment.
  • Subjects must have positive skin-prick test to common allergens (cat, dust mite, grass, pollen).
  • Subjects must have a positive EAR of >=20% fall in FEV1 measured from the FEV1 immediately prior to challenge, and LAR of >=15% fall in FEV1 from the FEV1 measured immediately prior to challenge during Screening period.
  • Subjects must be free from asthma exacerbation for at least 4 weeks before Screening. An exacerbation is defined as an occurrence of any clinical deterioration of asthma that requires emergency treatment, hospitalization due to asthma, or treatment with additional medication, as judged by the clinical investigator.
  • Subjects must be free from relevant seasonal allergen exposure for at least 4 weeks before the study and be able to remain so for the duration of the study.
  • Subjects must have current nonsmoking status. If previous smokers, cumulative smoking history must be fewer than 10 pack-years (pack-year=20 cigarettes smoked daily for 1 year). Previous smokers must not have smoked within 1 year before Screening.
  • Subjects must be willing to give written informed consent to participate in the study.
  • Subjects must have the ability to comply with the dosing regimen, to adhere to the visit schedule, and to participate in all treatment procedures, including sputum induction.
  • Female subjects of childbearing potential must have a negative serum pregnancy tests (human chorionic gonadotropin; hCG) at Screening and must use 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 include hormonal implants, oral contraceptives, hormonal patches,

intravaginal ring, medically acceptable prescribed intrauterine devices (IUDs), and a monogamous relationship with a male partner who has had a vasectomy. A 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.

  • Subjects, if male and sexually active with women of childbearing potential, must agree to use an adequate form of contraception for the duration of the study and to have sexual relations with only those women who use a highly effective birth control method.
  • Subjects' clinical laboratory tests (complete blood count [CBC], blood chemistries, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor.

Exclusion Criteria:

  • Subject has had a diagnosis of chronic obstructive pulmonary disease (COPD) or any other clinically relevant lung disease (eg, cystic fibrosis, pulmonary fibrosis, bronchiectasis) other than mild allergic asthma, or has a history of having been intubated.
  • Subject has had a worsening of a respiratory tract infection within 4 weeks before Screening.
  • Subject has had any clinically significant abnormality; history of clinically significant hypotensive episodes of fainting, dizziness, or lightheadedness; history or symptoms of cardiovascular disease; significant neurologic disease; or hematologic abnormality, including coagulopathy; or has a medication regimen or clinically relevant medical condition other than asthma that may interfere with the effect of study medication.
  • Subject had a peripheral blood neutrophil (PBN) count of <3 × 10^9/L at the Screening Visit.
  • Subject had an allergy/sensitivity to the study drug or its excipients.
  • Subject is pregnant, breast-feeding, or intends to become pregnant during the study.
  • Subject has used any investigational drug within 30 days or 5 half-lives of Screening.
  • Subject is presently participating in any other clinical study.
  • Subject is part of the staff personnel directly involved with this study
  • Subject is a family member of the investigational study staff.
  • Subject has received any treatment listed in Table 3 of the protocol or any medication that may interfere with the effect of the study medication more recently than the indicated washout period prior to Screening or must continue to receive treatment that is listed in Table 3 in the protocol.
  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

No publications provided

Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00688467     History of Changes
Other Study ID Numbers: P05363
Study First Received: May 29, 2008
Last Updated: March 5, 2014
Health Authority: Canada: Health Canada

Keywords provided by Merck Sharp & Dohme Corp.:
Neutrophilic Asthma

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 August 21, 2014