Intradermal allergen immunotherapy in adults with seasonal allergic rhinitis

Completed

• Conditions: Respiratory disease; Respiratory

• Registration Number: ISRCTN78413121
• Lead Sponsor: King's College London (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-19
• Last Update Posted: 15 January 2018

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

1. Adults aged 18 to 65 years
2. A clinical history of grass pollen-induced allergic rhinoconjunctivitis for at least 2 years with peak symptoms in May, June, or July.
3. A clinical history of moderate-severe persistent rhinoconjunctivitis symptoms interfering with usual daily activities or with sleep.
4. A clinical history of rhinoconjunctivitis that remains troublesome despite treatment with either antihistamines or nasal corticosteroids during the grass pollen season.
5. Positive skin prick test response, defined as wheal diameter greater than or equal to 3 mm, to Phleum pratense.
6. Positive specific IgE, defined as greater than or equal to IgE class 2, against Phleum pratense.
7. For women of childbearing age, a willingness to use an effective form of contraception for the duration of intradermal injections.
8. The ability to give informed consent and comply with study procedures
9. Male or female

Exclusion Criteria

1. Pre-bronchodilator FEV1 less than 70% of predicted value at screening visit
2. A history of seasonal grass pollen-induced asthma requiring regular treatment with salbutamol or inhaled corticosteroids. Patients with mild seasonal grass pollen-induced asthma may be included, provided symptoms are satisfactorily controlled with occasional salbutamol only.
3. A clinical history of symptomatic seasonal allergic rhinitis and/or asthma due to tree pollen or weed pollen near or overlapping the grass pollen season.
4. A clinical history of symptomatic allergic rhinitis and/or asthma caused by a perennial allergen to which the participant is regularly exposed.
5. Emergency department visit or hospital admission for asthma in the previous 12 months.
6. History of chronic obstructive pulmonary disease.
7. History of significant recurrent acute sinusitis, defined as 2 episodes per year for the last 2 years, all of which required antibiotic treatment.
8. 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 discoloured 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.
9. At randomisation, 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
10. Current smokers or a history of greater than or equal to 5 pack years
11. Previous treatment by immunotherapy with grass pollen allergen within the previous 5 years
12. History of life-threatening anaphylaxis or angioedema
13. Ongoing systemic immunosuppressive treatment
14. History of intolerance of grass pollen immunotherapy, rescue medications or their excipients
15. For females of childbearing age a positive serum or urine pregnancy test with sensitivity of less than 50 mIU/mL within 72 hours of first administration of study therapy
16. Lactating females
17. The use of any investigational drug within 30 days of the screening visit
18. Ongoing treatment with beta-blockers, calcium channel blockers, tricyclic antidepressants, monoamine oxidase inhibitors or anti-IgE monoclonal antibody
19. The presence of any medical condition that the investigator deems incompatible with participation in the trial
20. Individuals with insufficient understanding of the trial

Study & Design

• Study Type: Interventional
• Study Design: Not specified