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AsthmaPhase 1NCT01221285

Development of Cockroach Immunotherapy by the Inner-City Asthma Consortium

A Phase 1 study testing German cockroach (Blattella germanica) allergenic extract in people with Asthma and Perennial Allergic Rhinitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This trial is a biomarker-based pilot study of the safety of Cockroach Subcutaneous Immunotherapy in Cockroach-sensitive Adults (SCITCO) who have a history of perennial allergic rhinitis, asthma, or both. Read more about this study

Who is it for?
Ages 18 to 55 years
Conditions the study is for
Asthma, Perennial Allergic Rhinitis
What is being tested?
German cockroach (Blattella germanica) allergenic extract
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
11 participants
Where
1 siteUnited States
Study dates
Sep 2010to Oct 2011
Phase
Phase 1
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 55 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Have a history of perennial allergic rhinitis, asthma, or both, for a minimum of 1 year before study entry. For those with asthma:
  • a diagnosis of asthma will be defined as a report by the participant that they have had a clinical diagnosis of asthma made by a physician over a year ago
  • the participant's asthma must be well controlled as defined by:
  • a forced expiratory volume at one second (FEV1) greater than or equal to 80% predicted value with or without controller medication
  • albuterol use for no more than 3 days per week in each of the previous 2 weeks for asthma symptoms (not including exercise prophylaxis)
  • Are sensitive to German cockroach (Blattella germanica) as documented by a positive (>= 3 mm greater than negative control) skin prick test result and detectable German cockroach specific IgE (>=0.35 kUA/L)
  • Have no known contraindications to therapy with glycerinated German (Blattella germanica) cockroach allergenic extract
  • Are willing to sign the written Informed Consent prior to initiation of any study procedure

Who cannot join

  • Are pregnant or lactating. Females must be abstinent or use a medically acceptable birth control method throughout the study (e.g. oral, subcutaneous, mechanical, or surgical contraception)
  • Are unable to perform spirometry at screening
  • Have an asthma severity classification at recruitment of severe persistent, using the National Asthma Education and Prevention Program (NAEPP) classification, as evidenced by at least one of the following:
  • requires a dose of greater than 500 mcg of fluticasone per day or the equivalent of another inhaled corticosteroid
  • have received more than 2 courses of oral or parenteral corticosteroids within the last 12 months
  • have been treated with depot steroids within the last 12 months
Show all 18Show fewer
  • have been hospitalized for asthma within the 6 months prior to recruitment
  • have had a life-threatening asthma exacerbation that required intubation, mechanical ventilation, or that resulted in a hypoxic seizure within 2 years prior to recruitment
  • Do not have access to a phone (needed for scheduling appointments)
  • Have received allergen immunotherapy (SLIT or SCIT) in the last 12 months prior to recruitment or who plan to initiate or resume allergen immunotherapy during the study. Subjects who only received placebo therapy in the BioCSI protocol (A Biomarker-based Pilot Study of Cockroach Sublingual Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis, ICAC-12, NCT00829985) are eligible to participate in this study
  • Have previously been treated with anti-IgE therapy within 1 year of recruitment
  • Have received an investigational drug in the 30 days prior to recruitment or who plan to use an investigational drug during the study
  • Refuse to sign the Epinephrine Auto-injector Training Form
  • Do not primarily speak English
  • Plan to move from the area during the study period
  • Have a history of idiopathic anaphylaxis or anaphylaxis grade 2 or higher as defined in the protocol
  • Have unstable angina, significant arrhythmia, uncontrolled hypertension, history of autoimmune disease, or other chronic or immunological diseases that in the opinion of the investigator might interfere with the evaluation of the investigational agent or pose additional risk to the participant
  • Are using tricyclic antidepressants or beta-adrenergic blocker drugs (either oral or topical route[s] of administration)

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Johns Hopkins University School of Medicine

    Baltimore, Maryland, 21287

Other trials in United States

About this study

Official title: A Biomarker-Based Pilot Study of Cockroach Subcutaneous Immunotherapy in Cockroach Sensitive Adults With Asthma and/or Perennial Allergic Rhinitis (ICAC-18)

This trial is a biomarker-based pilot study of the safety of Cockroach Subcutaneous Immunotherapy in Cockroach-sensitive Adults (SCITCO) who have a history of perennial allergic rhinitis, asthma, or both.

Read the detailed description

Scientific evidence has shown that, over the past two decades, the combination of cockroach allergy and cockroach exposure is one of the most important factors contributing to the dramatic increase in asthma morbidity seen in inner city children with asthma. Therefore, a major goal of the Inner City Asthma Consortium (ICAC) is to evaluate the efficacy of cockroach immunotherapy in inner city asthma.

Being tested
German cockroach (Blattella germanica) allergenic extract
Keywords
Cockroach, Immunotherapy, Subcutaneous immunotherapy, Inner city asthma
Medical subject headings
Asthma, Rhinitis, Allergic, Perennial

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • German cockroach (Blattella germanica) allergenic extractBiological

    Participants received weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.

Study groups in NCT01221285
Study groupRoleWhat they receive
German cockroach allergenic extractExperimentalParticipants will receive weekly escalating doses of glycerinated German cockroach allergenic extract administered via the subcutaneous route up to a Maximum Study Dose of 0.6 mL of extract at a concentration of 1:20 wt/vol.
Receives: Biological: German cockroach (Blattella germanica) allergenic extract

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Reported Treatment-related Adverse Events (AEs)

    Number of non-serious adverse events reported as possibly related, probably related, or definitely related to study participation.

    Measured: Baseline through 6-months of treatment

  2. Number of Reported Treatment-related Serious Adverse Events (SAEs)

    Number of SAEs reported as possibly related, probably related, or definitely related to study participation.

    Measured: Baseline through 6-months of treatment

Secondary outcomes (4)

  1. Change in German Cockroach-Specific Serum IgE Over Time

    Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin E (IgE) vs. post-baseline German cockroach-specific serum IgE. Numerator is geometric mean post-baseline IgE; denominator is baseline IgE. This result is an indicator of immune modulation over time, however its clinical significance is unclear.

    Measured: Baseline through 6-months of treatment

  2. Change in German Cockroach-Specific Serum IgG Over Time

    Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin G (IgG) vs. post-baseline German cockroach-specific serum IgG. Numerator is geometric mean post-baseline IgG; denominator is baseline IgG.This result is an indicator of immune modulation over time, however its clinical significance is unclear.

    Measured: Baseline through 6-months of treatment

  3. Change in German Cockroach-Specific Serum IgG4 Over Time

    Outcome is the ratio of geometric means for baseline German cockroach-specific serum Immunoglobulin subclass 4 (IgG4) vs. post-baseline German cockroach-specific serum IgG4. Numerator is geometric mean post-baseline IgG4; denominator is baseline IgG4. This result is an indicator of immune modulation over time, however its clinical significance is unclear.

    Measured: Baseline through 6-months of treatment

  4. Change in IgE Fragment Antibody Binding (FAB) Activity (10 Micrograms/mL Cockroach Allergen Extract)

    Outcome is the change in mean IgE fragment antibody binding (FAB) activity, baseline to post-baseline. Serum from cockroach subcutaneous immunotherapy (SCIT)-treated participants were analyzed to determine if treatment inhibits the in-vitro cockroach antigen binding to B-cells after 6-months of treatment with cockroach SCIT, using the per protocol allergenic extract doses. This result is an indicator of immune modulation over time, however its clinical significance is unclear.

    Measured: Baseline through 6-months of treatment

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2010 (estimated)
  2. Study startSep 2010
  3. Primary completionOct 2011
  4. Study completionOct 2011

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
11 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01221285
Sponsor's protocol ID
DAIT ICAC-18
Other IDs
SCITCO
Status last verified
Jun 2014
First submitted
13 Oct 2010
Last updated
11 Jun 2014
Data monitoring committee
Yes

Publications

  • Wood RA, Togias A, Wildfire J, Visness CM, Matsui EC, Gruchalla R, Hershey G, Liu AH, O'Connor GT, Pongracic JA, Zoratti E, Little F, Granada M, Kennedy S, Durham SR, Shamji MH, Busse WW. Development of cockroach immunotherapy by the Inner-City Asthma Consortium. J Allergy Clin Immunol. 2014 Mar;133(3):846-52.e6. doi: 10.1016/j.jaci.2013.08.047. Epub 2013 Nov 1.

    PubMed 24184147

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing German cockroach (Blattella germanica) allergenic extract in people with Asthma and Perennial Allergic Rhinitis, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Jun 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 May 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Reported Treatment-related Adverse Events (AEs) (time frame: Baseline through 6-months of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01221285, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2014.

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