Long-Term Effects of Sublingual Grass Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborators:
Immune Tolerance Network (ITN)
Imperial College London
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier:
NCT01335139
First received: April 8, 2011
Last updated: August 2, 2013
Last verified: August 2013
  Purpose

The purpose of this research study is to investigate whether sublingual immunotherapy (SLIT, grass pollen tablets under the tongue) has long term effects in severe hay fever.


Condition Intervention Phase
Rhinitis, Allergic, Seasonal
Biological: Grazax
Biological: Alutard SQ
Other: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Single-center, Placebo Controlled Study of Sublingual Immunotherapy and Subcutaneous Immunotherapy in Adults With Seasonal Allergic Rhinitis (ITN043AD)

Resource links provided by NLM:


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

Primary Outcome Measures:
  • Nasal response to allergen challenge [ Time Frame: 3 years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Skin late phase response [ Time Frame: 1,2, and 3 years ] [ Designated as safety issue: No ]
  • Skin early phase response [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Nasal late phase response [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Nasal early phase response [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Peak nasal inspiratory flow late phase response [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Peak nasal inspiratory flow early phase response [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Skin prick test endpoint titration [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Use of rescue medications during the pollen season [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Quality-of-life questionnaire score measured pre-, peak-, and post- pollen season [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Hay fever severity score measured at the end of each pollen season [ Time Frame: 1, 2 and 3 years ] [ Designated as safety issue: No ]
  • Weekly visual analog symptom scores measured pre-, peak-, and post-pollen season [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Mechanistic assessments of local immune responses in the nasal mucosa before and after nasal allergen challenge. [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]
  • Mechanistic assessments of peripheral blood subsets before and after therapy. [ Time Frame: 1, 2, and 3 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: March 2011
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Subcutaneous immunotherapy (SCIT)
Subcutaneous immunotherapy (SCIT) + sublingual immunotherapy (SLIT) placebo
Biological: Alutard SQ
Experimental: Sublingual immunotherapy (SLIT)
Sublingual immunotherapy (SLIT) + subcutaneous immunotherapy (SCIT) placebo
Biological: Grazax
Placebo Comparator: Placebo
Sublingual immunotherapy (SLIT) placebo + subcutaneous immunotherapy (SCIT) placebo
Other: Placebo

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May, June, or July.
  • A clinical history of moderate - severe rhinoconjunctivitis symptoms interfering with usual daily activities or with sleep as defined according to the ARIA classification of rhinitis.
  • A clinical history of rhinoconjunctivitis for at least 2 years requiring treatment with either antihistamines or nasal corticosteroids during the grass pollen season.
  • Positive skin prick test response, defined as wheal diameter greater than or equal to 3 mm, to Phleum pratense.
  • Positive specific IgE, defined as greater than or equal to IgE class 2 (0.7 kU/L), against Phleum pratense.
  • A positive response to nasal allergen challenge with Phleum pretense, defined as an increase in TNSS greater than or equal to 7 points above baseline.
  • For women of childbearing age, a willingness to use an effective form of contraception for the duration of the trial.
  • The ability to give informed consent and comply with study procedures.

Exclusion Criteria:

  • Prebronchodilator FEV1 less than 70% of predicted value at either screening or baseline visit.
  • A clinical history of moderate - severe allergic rhinitis, according to the ARIA classification, due to tree pollen near or overlapping the grass pollen season.1
  • A clinical history of persistent asthma and/or requiring regular inhaled corticosteroids for > 4 weeks per year outside of the grass pollen season.
  • A clinical history of moderate- severe allergic rhinitis, according to the ARIA classification, caused by an allergen to which the participant is regularly exposed.1
  • History of emergency visit or hospital admission for asthma in the previous 12 months.
  • History of chronic obstructive pulmonary disease.
  • History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.
  • History of chronic sinusitis, defined as a sinus symptoms lasting greater than 12 weeks that includes 2 or more major factors or 1 major factor and 2 minor factors. Major factors are defined as facial pain or pressure, nasal obstruction or blockage, nasal discharge or purulence or discolored postnasal discharge, purulence in nasal cavity, or impaired or loss of smell. Minor factors are defined as headache, fever, halitosis, fatigue, dental pain, cough, and ear pain, pressure, or fullness.
  • At randomization, current symptoms of, or treatment for, upper respiratory tract infection, acute sinusitis, acute otitis media, or other relevant infectious process; serous otitis media is not an exclusion criterion. Participants may be re-evaluated for eligibility after symptoms resolve.
  • Any tobacco smoking within the last 6 months or a history of greater than or equal to 10 pack years.
  • Previous treatment by immunotherapy with grass pollen allergen within the previous 5 years.
  • Any history of grade 4 anaphylaxis due to any cause as defined by the WAO grading criteria for immunotherapy (see appendix 7).
  • History of bleeding disorders or treatment with anticoagulation therapy
  • History of anti-IgE monoclonal antibody treatment.
  • Ongoing systemic immunosuppressive treatment.
  • History of intolerance to the study therapy, rescue medications, or their excipients.
  • For women of childbearing age a positive serum or urine pregnancy test with sensitivity of less than 50 mIU/mL within 72 hours before the start of study therapy.
  • The use of any investigational drug within 30 days of the screening visit.
  • The presence of any medical condition that the investigator deems incompatible with participation in the trial.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01335139

Locations
United Kingdom
Royal Brompton Hospital
London, United Kingdom, SW3 6LY
Sponsors and Collaborators
Immune Tolerance Network (ITN)
Imperial College London
Investigators
Study Chair: Stephen Durham, MD Imperial College London
  More Information

Additional Information:
No publications provided

Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01335139     History of Changes
Other Study ID Numbers: DAIT ITN043AD, 2010-023536-16
Study First Received: April 8, 2011
Last Updated: August 2, 2013
Health Authority: United Kingdom: Research Ethics Committee
United Kingdom: Medicines and Healthcare Products Regulatory Agency
United States: Federal Government

Keywords provided by National Institute of Allergy and Infectious Diseases (NIAID):
sublingual immunotherapy
subcutaneous immunotherapy

Additional relevant MeSH terms:
Rhinitis, Allergic, Seasonal
Rhinitis
Nose Diseases
Respiratory Tract Diseases
Respiratory Hypersensitivity
Otorhinolaryngologic Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Respiratory Tract Infections

ClinicalTrials.gov processed this record on April 15, 2014