Effects of Multiple Nasal Exposures to House Dust Mite Allergen on Nasal and Body Inflammation and Airway Sensitivity
This study has been completed.
Sponsor:
Novartis
Information provided by:
Novartis
ClinicalTrials.gov Identifier:
NCT00513487
First received: August 6, 2007
Last updated: July 14, 2008
Last verified: July 2008
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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 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Pharmacodynamics Study Intervention Model: Parallel Assignment Masking: Open Label |
| 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 |
Resource links provided by NLM:
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:
-
Drug: Dust mite extract, Fluticasone, Methacholine
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 More Information
No publications provided
| Responsible Party: | External Affairs, Novartis |
| ClinicalTrials.gov Identifier: | NCT00513487 History of Changes |
| Other Study ID Numbers: | CPJMR0052107 |
| Study First Received: | August 6, 2007 |
| Last Updated: | July 14, 2008 |
| Health Authority: | Australia: Department of Health and Ageing Therapeutic Goods Administration |
Keywords provided by Novartis:
|
Allergic Rhinitis dust mites IgE |
IL-13 nasal inflammation |
Additional relevant MeSH terms:
|
Inflammation Rhinitis Pathologic Processes Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Methacholine Chloride Fluticasone Miotics Autonomic Agents Peripheral Nervous System Agents Physiological Effects of Drugs Pharmacologic Actions |
Parasympathomimetics Bronchoconstrictor Agents Respiratory System Agents Therapeutic Uses Muscarinic Agonists Cholinergic Agonists Cholinergic Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Bronchodilator Agents Anti-Asthmatic Agents Dermatologic Agents Anti-Allergic Agents Anti-Inflammatory Agents |
ClinicalTrials.gov processed this record on June 18, 2013