CLINICAL TRIALS

  • Clinical Trials

     

  • Sarasota Clinical Research

    Sarasota Clinical Research is the research arm of Windom Allergy.

    Clinical trials keep us on the cutting edge of new medical discoveries and provide our patients a unique opportunity to be exposed to investigational agents on the verge of FDA approval.

We have been conducting these national and international pharmaceutical trials in our Sarasota, Florida office since 1994. While the majority of our clinical trials involve medications for the treatment of asthma and COPD/emphysema, we are also active in research studies related to food allergy, allergic rhinitis, and urticaria (hives).   We currently have patients in studies of the first products being developed for peanut allergy: an oral capsule of peanut flour used in an Oral Immunotherapy (OIT) protocol and the peanut patch applied to the patient’s back.

 

Why Participate In Clinical Trials?

  • Participation in clinical trials provides access to new treatments long before they are approved for the overall population
  • Help defray the high cost of daily prescription therapy
  • Receive expert medical care from the medical staff at Windom Allergy
  • All medical visits and procedures are provided at no expense to the participant
  • Most studies include patient compensation for time and travel
  • Helps for the advancement of medical science

Participating in research is a process of performing a series of clinical trials to test each investigational drug for the potential to become a new medicine. The effect of the potential drug will often be compared to that of an inactive substance, a placebo, which is prepared to look like the drug so as to prevent bias during the trial. The investigational drug may also be compared against marketed medicines.

 

Phase I trials typically involve healthy volunteers. These trials study the safety of the drug and its interaction with the body, for example, its concentration and duration in the blood following various doses.

Phase II studies enroll patients with the illness an investigational drug is designed to treat. These trials evaluate whether the drug shows favorable effects in treating an illness and seek to determine the proper dose. The evaluation of safety continues. If Phase II results have been encouraging, Phase III trials, the largest part of a clinical-development program, go forward.

Phase III trials are designed to provide the substantial evidence of efficacy and safety required, in addition to data from earlier-phase trials before regulatory agencies will approve the investigational drug as a medicine and allow it to be marketed. Trials of a medicine may continue even after it has been approved for marketing. Known as Phase IV trials, they may further evaluate the effect of the medicine for the approved use. Although pharmaceutical companies design and take responsibility for the trials they sponsor, any clinical-development program ultimately depends on the commitment of the physician and the patients they enroll in the settings of clinics and hospitals. A new medicine, or new use of a medicine, is the result of a collaborative, often international effort.

Patient Demographics

Patient recruitment is facilitated primarily through Windom Allergy in Sarasota, Florida, previous study participants, and through radio, newspaper and television advertising.

Current Studies

Typical enrolling studies include ASTHMA (PEDIATRIC AND ADULT), COPD, ALLERGIC RHINITIS. For information on our currently enrolling studies please contact Sally at: Research@WindomAllergy.com or 941-927-4888

Past Studies

Windom Allergy has been conducting research studies in the Sarasota office since 1994. While the majority of trials involve medications for the treatment of asthma, there have been numerous studies for patients with COPD/emphysema, hay fever and hypertension. A partial list of medications studied and subsequently approved by the FDA include: Nasonex®, Advair®, Symbicort®, Xolair®, Spiriva®, Foradil®, Asmanex®, Omnaris®, Tekturna®, Dulera®, Tudorza®, Pressair®, Onbrez®, and Perforomist®.

Sally A. Kastes

Clinical Research Coordinator

Sally Kastes, RN, CCRC, is the Chief Operating Officer and full-time Certified Clinical Research Coordinator. She has extensive experience in respiratory research having conducted over 100 chronic obstructive pulmonary disease (COPD) and asthma trials in Florida since 2001.

Sally maintains the Academy of Clinical Research Professionals (ACRP) certification which is the formal recognition of professionals who have demonstrated the knowledge, skills and abilities to perform ethical and responsible clinical research based on international standards.

Sally also maintains certification with the American Association for Respiratory Care (AARC), IATA Dangerous Goods Transportation, Cambridge Cognitive Development, phlebotomy, EKG, Holter monitoring, IV infusion, allergy skin testing, patient education, CPR and Hazmat.