Validation of an Environmental Exposure Chamber for Inhalation Studies With House Dust Mite Allergen in Patients With Allergic Rhinitis

NCT01275456 | Completed DMC

• 1 other identifier: 09/01 Valex1
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief Summary

This clinical validation study is aimed at testing the efficacy of a new environmental challenge chamber (ECC) to induce symptoms of allergic rhinitis in patients allergic to house dust mite. The symptoms will be recorded on a validated symptom score as Total Nasal Symptom Score (TNSS), allowing for determine whether the challenge is dose dependent and reproducible.

Conditions

Allergy to House Dust Mite

Keywords

allergen provocation; environmental challenge; allergen chamber; house dust mite; immunotherapy

Outcome Measures

Primary Outcomes (1)

• Total nasal symptom score (TNSS)

  To assess the effect of a 4 hour-environmental allergen challenge with house dust mite extract in an ECC on the total nasal symptom score (TNSS), defined as the sum of obstruction, rhinorrhea, itch, and sneeze, each of which has been scored on a scale from 0 to 3.

  During 4 hours of challenge

Secondary Outcomes (5)

• Rhinomanometry

  During 4 hours of challenge

• visual analogue scale (VAS) for total nasal symptoms

  During 4 hours of challenge

• Nasal secretion

  during 4 hours of challenge

• Exhaled Nitric Oxide (NO)

  during and up to 24 hours after challenge

• FEV1

  during and up to 24 hours after challenge

Interventions

Exposure to house dust mite PROCEDURE

0 SQE/qm for 4 hours 250 SQE/qm for 4 hours 500 SQE/qm for 4 hours 1000 SQE/qm for 4 hours

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female subjects aged 18-55 years.
• Non smokers or ex-smokers with a history of less than 10 pack years, having been nonsmokers for at least the last 12 months.
• History of allergic rhinitis to house dust mite. Subjects with mild intermittent asthma that is controlled with occasional use of as-needed short-acting beta-agonists may be included.
• Normal lung function (FEV1 ≥ 80 % pred)
• Positive skin prick test for dermatophagoides pteronyssinus.
• Able and willing to give written informed consent to take part in the study.
• Available to complete all study measurements.
• Not pregnant, as confirmed by pregnancy test (see flow chart) and not nursing.
• Of non-child bearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is pre-menarchial or post-menopausal, with documented proof of hysterectomy or tubal ligation, or meet clinical criteria for menopause and has been amenorrhoeic for more than 1 year prior to the screening visit).
• Of childbearing potential and using a highly effective method of contraception during the entire study (vasectomised partner, sexual abstinence - the lifestyle of the female should be such that there is complete abstinence from intercourse from two weeks prior to the first dose of study medication until at least 72 hours after treatment -, implants, injectables, combined oral contraceptives, hormonal IUDs or double-barrier methods, i.e. any double combination of IUD, condom with spermicidal gel, diaphragm, sponge, and cervical cap).

You may not qualify if:

• History of a respiratory tract infection and/or exacerbation of asthma within 4 weeks before the screening.
• Any history of life-threatening asthma, defined as an asthma episode that required intubation and/or was associated with hypercapnea, respiratory arrest or hypoxic seizures.
• Administration of oral, injectable or dermal corticosteroids within 8 weeks or intranasal and/or inhaled corticosteroids 4 weeks prior to enrollment.
• Past or present disease, which as judged by the investigator, may affect the outcome of this study. These diseases include, but are not limited to, cardiovascular disease, malignancy, hepatic disease, renal disease, hematological disease, neurological disease, endocrine disease or pulmonary disease (including but not confined to chronic bronchitis, emphysema, tuberculosis, bronchiectasis or cystic fibrosis).
• Any structural nasal abnormalities or nasal polyps on examination, history of frequent nose bleeding or recent nasal surgery.
• Conditions or factors, which would make the subject unlikely to be able to stay in the Fraunhofer ECC for four to six hours.
• Specific Immunotherapy (SIT) within the last two years prior to screening.
• Risk of non-compliance with study procedures.
• Participation in another clinical trial 30 days prior to enrolment.
• Any contraindication for adrenalin use (e.g. use of local and systemic beta-blockers)
• Intolerance to any excipients especially lactose and/or milk products
• History of drug or alcohol abuse

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead

Study Sites (1)

Fraunhofer-Institute for Toxicology and Experimental Medicine

Hanover, 30625, Germany

Location

Related Links

• Sponsor's homepage

MeSH Terms

Conditions

Dust Mite Allergy

Condition Hierarchy (Ancestors)

Rhinitis, Allergic, Perennial; Rhinitis, Allergic; Rhinitis; Nose Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Otorhinolaryngologic Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 10, 2011
• First Posted: January 12, 2011
• Study Start: January 1, 2011
• Primary Completion: May 1, 2011
• Study Completion: May 1, 2011
• Last Updated: July 6, 2011

Record last verified: 2011-07

Locations

DE (1)