Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Sublingual Cockroach Safety Study (SCSS)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT00434421
First received: February 12, 2007
Last updated: April 3, 2014
Last verified: April 2014
  Purpose

Immunotherapy may help reduce symptoms of allergy and asthma. Problems concerning compliance and adverse events with subcutaneous allergen immunotherapy have generated interest in delivering immunotherapy sublingually (under the tongue). The purpose of this study is to evaluate the safety of a cockroach extract given sublingually to people with perennial (year-round) allergic rhinitis, with or without asthma.


Condition Intervention Phase
Allergy
Asthma
Drug: Glycerinated German cockroach allergenic extract
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Safety and Pilot Dosing Study for Sublingual-Oral Administration of Glycerinated German Cockroach Allergenic Extract in Pediatric and Adult Subjects With Cockroach Allergy and Perennial Allergic Rhinitis With or Without Asthma

Resource links provided by NLM:


Further study details as provided by National Institute of Allergy and Infectious Diseases (NIAID):

Primary Outcome Measures:
  • Proportion of participants who discontinue study drug for any reason following initiation of treatment (any participant who receives the initial placebo dose will be considered initiated onto treatment) [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of participants who discontinue the study for treatment-related reasons [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Proportion of participants who undergo anaphylactic shock following treatment [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Proportion of participants requiring treatment for a systemic reaction to treatment [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Maximum tolerated dose for those unable to reach and maintain maximum study dose [ Time Frame: Throughout study ] [ Designated as safety issue: No ]
  • Adverse events, including measures of their severity, seriousness, and treatment relatedness [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Serious AEs, including measures of their severity and treatment relatedness [ Time Frame: Throughout study ] [ Designated as safety issue: Yes ]
  • Overall compliance with self-administered doses [ Time Frame: Throughout study ] [ Designated as safety issue: No ]

Enrollment: 28
Study Start Date: February 2007
Study Completion Date: August 2009
Primary Completion Date: August 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: Glycerinated German cockroach allergenic extract
    Concentrated (1:10 w/v) daily does placed under the tongue to dissolve, totaling 1,313,718 BAU per year. The extract is also administered during the Preliminary Dosing Visits in up to 8 escalating doses or until the maximum study dose (420 microliters, 1:10 w/v) is achieved.
Detailed Description:

The prevalence of asthma has dramatically increased in many parts of the world. Currently, there is no effective way to prevent development of allergic rhinitis and asthma and no cure. Sublingual immunotherapy (SLIT), a type of therapy in which allergens are placed under the tongue, may be a way to control and possibly prevent allergic rhinitis and asthma. However, detailed research of this approach is limited. The purpose of this study is to evaluate the safety and tolerability of a sublingual cockroach extract given to people with perennial allergic rhinitis. Participants in this study will include people both with and without asthma.

Participation in this study will last a little more than 2 weeks. Participants will be stratified by age (oldest to youngest age group) and degree of cockroach sensitivity. Each age group will be enrolled after the previous group's safety data have been reviewed. At study entry (Day 0), participants will receive a dose of placebo and then up to seven incremental doses of cockroach extract at 15-minute intervals while observed by the clinic nurse. Doses will continue to be given until a sign or symptom occurs that indicates the participant is having difficulty tolerating the drug, or until the maximum study dose is reached.

At the Principal Investigator's discretion, participants who were able to achieve the maximum study dose will be invited to continue onto the 2-week treatment course of the study. These participants will return on Days 1 and 2 to the clinic to self-administer the maximum study dose of cockroach extract. After self-administering the maximum study dose, participants will be observed by the clinic nurse for 30 minutes. On Days 3 through 14, participants will take the maximum study dose of cockroach extract daily at home. Participants will be asked to keep a diary and record signs or symptoms experienced after taking each dose.

Skin tests, breathing tests, and blood collection will occur at study screening. At study entry, participants will be taught to use an EpiPen in the event of a severe allergic reaction at any time during the study. A physical exam/fitness assessment will be done at study screening, study entry, and the final visit. Unused extract will be collected at the final visit from participants who entered the 2-week treatment course of the study.

  Eligibility

Ages Eligible for Study:   5 Years to 39 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria for All Participants:

  • History of perennial allergic rhinitis with or without asthma for a minimum of 1 year prior to study entry
  • Positive skin prick test to German cockroach performed along with negative (saline) and positive (histamine) controls
  • Willing to sign EpiPen training form
  • Parent or guardian willing to provide informed consent, if applicable

Inclusion Criteria for Participants with Asthma:

  • Diagnosis of well-controlled, mild to moderate persistent asthma, defined as having symptoms at least 3 times a week with no controller medication OR less than 3 times a week on controller medication. More information about this criterion can be found in the protocol.
  • Diagnosis of asthma made over 1 year prior to study entry

Exclusion Criteria:

  • Have severe, persistent asthma (according to National Asthma Education and Prevention Program [NAEPP] classification) as evidenced by those who require a dose of greater than 500 mcg of fluticasone/day or equivalent of another inhaled corticosteroid OR who have been hospitalized for asthma within 6 months prior to study entry
  • Life-threatening asthma exacerbation requiring intubation or mechanical ventilation or resulting in a hypoxic seizure in the 2 years prior to study entry
  • History of anaphylaxis of Grade 2 or higher as defined in the protocol
  • Unstable angina, significant arrhythmia, uncontrolled hypertension, or other chronic or immunologic diseases that, in the opinion of the investigator, may interfere with the study or pose additional risk to the patient. More information about this criterion can be found in the protocol.
  • Taking medications that could induce gastrointestinal reactions during the study. Participants taking such medications must prove to be stable with no side effects for at least 3 months prior to study screening to be considered eligible.
  • Received an investigational drug in the 30 days prior to study entry OR plan to receive an investigational drug during the study
  • Received allergen immunotherapy in the 180 days prior to screening or plan to initiate or resume allergen immunotherapy during the study
  • Taking tricyclic antidepressants or beta-adrenergic blocker drugs
  • Received omalizumab in the 3 months prior to study screening
  • Known contraindication to therapy with cockroach extract used in this study
  • Mental illness that would interfere with the participant's ability to comply to study requirements
  • History of drug or alcohol abuse that, in the opinion of the investigator, would interfere with the study
  • Plan to leave study area during the study
  • Does not primarily speak English, including caretakers of participants when the participant is a child
  • Cannot perform spirometry
  • Pregnant or breastfeeding
  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.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00434421

Locations
United States, Maryland
Johns Hopkins University School of Medicine, 600 North Wolfe St, CMSC 1102
Baltimore, Maryland, United States, 21287
Sponsors and Collaborators
Investigators
Principal Investigator: Robert Wood, MD Johns Hopkins University
  More Information

Additional Information:
Publications:
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT00434421     History of Changes
Other Study ID Numbers: DAIT ICAC-10, SCSS
Study First Received: February 12, 2007
Last Updated: April 3, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
Perennial Allergic Rhinitis
Hay Fever
Immunotherapy
Asthma

Additional relevant MeSH terms:
Asthma
Rhinitis, Allergic, Perennial
Bronchial Diseases
Hypersensitivity
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Nose Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Respiratory Tract Diseases
Rhinitis

ClinicalTrials.gov processed this record on November 27, 2014