Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity - Full Text View

Sponsored by:	Novartis
Information provided by:	Novartis
ClinicalTrials.gov Identifier:	NCT00513487

Purpose

This study will evaluate whether multiple nasal antigen challenges with dust mite allergen produces increases in nasal symptoms and local allergic inflammatory cells in the nose and the blood.

Condition	Intervention
Allergic Rhinitis	Drug: Dust mite extract, Fluticasone, Methacholine

Drug Information available for: Fluticasone Fluticasone propionate Methacholine Methacholine chloride

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Open Label, Placebo Control, Parallel Assignment, Pharmacodynamics Study
Official Title:	Assessment of the Effects of Multiple Nasal Antigen Challenges With Dust Mite Allergen on Local and Systemic Allergic Inflammation and Bronchoreactivity in Subjects With Allergic Rhinitis Sensitive to House Dust Mite - a Feasibility and Site Evaluation Study

Further study details as provided by Novartis:

Primary Outcome Measures:

Total nasal symptom score recorded at baseline, and at pre-challenge,15 mins, 30 mins,and at 1,2,3,4,8 hours [ Time Frame: throughout the study ]

Secondary Outcome Measures:

Peak nasal inspiratory flow at time points of total nasal symptom score. Mechanistic markers during challenge days. Exhaled nitric oxide,forced expiratory vol in 1 second & airway resistance at baseline, first & last day [ Time Frame: throughout the study ]

Estimated Enrollment:	18
Study Start Date:	July 2007
Study Completion Date:	November 2007

Intervention Details:

Dust mite extract, Fluticasone, Methacholine

Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy non-smoking subjects with a history of allergic rhinitis consistent with dust mite allergy showing
A positive skin prick test to dust mite at or within the 12 months before study start
Demonstrate symptomatic worsening after graded nasal allergen challenge

Exclusion Criteria:

Subjects found to be very sensitive to house dust mites (if the skin prick test produces a wheal of mean with a diameter greater than 11 mm).
Presence of any respiratory disease other than a history of mild stable asthma not requiring regular treatment.
Any known contraindications for methacholine challenge testing

Other protocol-defined inclusion/exclusion criteria may apply.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00513487

Locations

Australia
Novartis Investigative site
Sydney, Australia

Sponsors and Collaborators

Novartis

Investigators

Principal Investigator:

Novartis

Investigative site

More Information

Responsible Party:	Novartis ( External Affairs )
Study ID Numbers:	CPJMR0052107
Study First Received:	August 6, 2007
Last Updated:	July 14, 2008
ClinicalTrials.gov Identifier:	NCT00513487
Health Authority:	Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Novartis:

Allergic Rhinitis
dust mites
IgE

IL-13
nasal
inflammation

Study placed in the following topic categories:

Otorhinolaryngologic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Methacholine Chloride

Fluticasone
Rhinitis
Inflammation

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Parasympathomimetics
Respiratory System Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Cholinergic Agonists
Bronchoconstrictor Agents
Miotics
Physiological Effects of Drugs
Anti-Asthmatic Agents
Anti-Allergic Agents

Cholinergic Agents
Nose Diseases
Pharmacologic Actions
Pathologic Processes
Autonomic Agents
Therapeutic Uses
Muscarinic Agonists
Peripheral Nervous System Agents
Dermatologic Agents
Bronchodilator Agents

ClinicalTrials.gov processed this record on January 15, 2009