Sublingual Cockroach Safety Study (SCSS)
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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 |
- 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 ]
- 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) |
-
Drug: Glycerinated German cockroach allergenic extract
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 |
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| United States, Maryland | |
| Johns Hopkins University School of Medicine, 600 North Wolfe St, CMSC 1102 | |
| Baltimore, Maryland, United States, 21287 | |
| 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: | February 6, 2013 |
| 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:
|
Hypersensitivity Asthma Rhinitis, Allergic, Perennial Immune System Diseases Bronchial Diseases Respiratory Tract Diseases Lung Diseases, Obstructive |
Lung Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Rhinitis Nose Diseases Otorhinolaryngologic Diseases |
ClinicalTrials.gov processed this record on May 16, 2013