Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges* (Roche)
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ClinicalTrials.gov Identifier: NCT01240889 |
Recruitment Status :
Completed
First Posted : November 15, 2010
Last Update Posted : October 10, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Allergy | Drug: Fluticasone Drug: Fluticason | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 60 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | Effects of Intranasal Corticosteroid and Montelukast On Nasal Allergen Challenges* |
Study Start Date : | November 2010 |
Actual Primary Completion Date : | July 2011 |
Actual Study Completion Date : | July 2011 |

Arm | Intervention/treatment |
---|---|
Active Comparator: montelukast
luekotriene inhibitor
|
Drug: Fluticasone
nasal spray |
Active Comparator: Fluticasone
Nasal steroid
|
Drug: Fluticason
2 sprays per day in each nostril |
- Effect of nasal allergen challenges on biomarkers [ Time Frame: December 2011 ]

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Ages Eligible for Study: | 19 Years to 60 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female subjects aged 19-60 years.
- Females of child bearing potential must use appropriate birth control throughout the study and urine pregnancy tests must be negative prior to dosing at each study visit.
- Subjects with a documented history of ragweed-induced seasonal allergic rhinitis requiring pharmacotherapy during the preceding 2 allergen seasons.
- Subjects with a positive skin prick test to short ragweed (Amb a 1) extract, defined as >3mm wheal larger than saline control
- Subjects spirometry FEV1 must be > 80% predicted prior to each allergen challenge
- Subjects average post diluents nasal congestion score must be < 1 at admission for each study visit
Exclusion Criteria:
- Subjects with evidence or history of clinically significant medical illnesses other than changes related to allergic rhinitis. Subjects with some stable chronic medical conditions not expected to interfere with the conduct or safety of the study may be eligible to participate based on the investigator's discretion.
- Subjects with a history of asthma or urticaria, or a screening FEV1 prior to allergen challenge of <80% of predicted. in FEV1 compared to pre-diluent FEV1 baseline at either screening visit.
- Subjects with significant nasal deformity, recent nasal surgery nasal polyps or chronic rhinosinusitis.
- Subjects who have smoked in the last 6 months or have a history of >10 pack years.
- Subjects who are taking or have taken restricted concomitant medications that could confound the safety or efficacy assessments including those shown below.
- Subjects who have history or evidence of alcohol or drug abuse.
- Subjects exposed to cat and have a positive skin test to cat.
- Subjects that have a positive skin test to dust mite (D pteronyssinus/ D farinae) requiring pharmacotherapy

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01240889
United States, Nebraska | |
Creighton University Medical Center | |
Omaha, Nebraska, United States, 68131 |
Principal Investigator: | Thomas B Casale, MD | Creighton University |
Responsible Party: | Thomas B. Casasle, MD, Creighton University |
ClinicalTrials.gov Identifier: | NCT01240889 |
Other Study ID Numbers: |
10-15912 |
First Posted: | November 15, 2010 Key Record Dates |
Last Update Posted: | October 10, 2012 |
Last Verified: | October 2012 |
Ragweed allergies acoustic rhinometry nasal allergen challenge |
Hypersensitivity Immune System Diseases Fluticasone Anti-Inflammatory Agents Bronchodilator Agents Autonomic Agents |
Peripheral Nervous System Agents Physiological Effects of Drugs Anti-Asthmatic Agents Respiratory System Agents Dermatologic Agents Anti-Allergic Agents |