Pollen Low Dose Intradermal Therapy Evaluation in Allergic Rhinitis

Phase 1

• Conditions: Allergic Rhinitis; MedDRA version: 14.1Level: LLTClassification code 10039776Term: Seasonal allergic rhinitisSystem Organ Class: 100000004855; Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]

• Registration Number: EUCTR2012-002193-31-GB
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-07-02
• Last Update Posted: 10 December 2018

Recruitment & Eligibility

• Status: ot Recruiting
• 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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 90
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

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, although patients with mild intermittent symptoms requiring only occasional antihistamines may be included.
4)A clinical history of symptomatic allergic rhinitis and/or asthma caused by a perennial allergen to which the participant is regularly exposed, although patients with mild intermittent symptoms requiring only occasional antihistamines may be included.
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 outside the grass pollen season, 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 leukotriene receptor antagonists, 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 clinical trial of medicinal product
• Study Design: Not specified