Lakeland Health Care

Events & Classes


Friday
14
February
2014
Category
Clinical Trial Opportunities
Location
5515 Cleveland Avenue, Stevensville MI, 49127, Phone: 269.932.1026
Start Date
02/14/2014
Description

Ages Eligible for Study: 12 Years and older
Genders Eligible for Study: Both
Accepts Healthy Volunteers: No

Inclusion Criteria:
  • History of AR/ARC to house dust of 1 year duration or more (with or without asthma)
  • If female of childbearing potential, has a negative urine pregnancy test at Screening and agrees to remain abstinent or use (or have their partner use) an acceptable method of birth control within the projected duration of the study
  • Able to read, understand and complete questionnaires and diaries

Exclusion Criteria:
  • Sensitized and regularly exposed to animal dander, molds and/or cockroach (e.g. present in the home, job, daycare, etc.) or other perennial allergen
  • History of symptomatic seasonal ARC and/or asthma due to an allergen to which the participant is sensitized and regularly exposed
  • Nasal condition that could confound the efficacy or safety assessments (e.g., nasal polyposis)
  • Received an immunosuppressive treatment within 3 months prior to screening (except steroids for allergic and asthma symptoms)
  • Unstable or severe asthma, or has experienced a life-threatening asthma attack or an occurrence of any clinical deterioration of asthma that resulted in emergency treatment, hospitalization due to asthma, or treatment with systemic corticosteroids (but allowing short-acting beta agonists [SABAs]) at any time within 3 months prior to screening
  • Asthma requiring high-dose inhaled corticosteroids (ICS) within 6 months prior to screening
  • History of anaphylaxis with cardiorespiratory symptoms with prior immunotherapy, unknown cause or inhalant allergen
  • History of chronic urticaria and/or angioedema within 2 years prior to screening
  • History of chronic sinusitis during 2 years prior to screening
  • Pregnant, breastfeeding, or expecting to conceive within the projected duration of the study
  • Previous immunotherapy treatment with any HDM allergen for more than 1 month within 5 years prior to screening
  • Receiving ongoing treatment with any specific immunotherapy at screening
  • Known history of allergy, hypersensitivity or intolerance to investigational medicinal products (except for D. pteronyssinus and/or D. farinae), rescue medications or self-injectable epinephrine
  • Unable to meet medication washout requirements prior to screening
  • Unable or unwilling to comply with the use of self-injectable epinephrine
  • Business or personal relationship with investigational site personnel or Sponsor who is directly involved with the conduct of the study
  • Likely to travel for extended periods of time during the efficacy assessment period


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Maximum Attendees
Unlimited
Cost/Fee
Free
Contact Information
For further information participants can contact our Research Department at (269) 429-6604 ext. 1881 or (269) 932-1026

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