A Study of Onset of Action of Loratadine and Fexofenadine in Participants With Seasonal Allergic Rhinitis (P08712)
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| ClinicalTrials.gov Identifier: NCT01469234 |
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Recruitment Status
:
Completed
First Posted
: November 10, 2011
Results First Posted
: March 22, 2013
Last Update Posted
: March 11, 2015
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The purpose of this study is to determine the onset of action of two commercially available over-the-counter antihistamines (Loratadine and
Fexofenadine) in a model of seasonal allergic rhinitis (SAR). Participants undergo sensitization exposures to Mountain Cedar (juniperus ashei) pollen in a Biogenics Research Chamber; those who demonstrate an adequate allergic response determined by the Major Symptom Complex (MSC) score will then receive drug.
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Rhinitis | Drug: loratadine Drug: fexofenadine Drug: placebo to loratadine Drug: placebo to fexofenadine | Phase 4 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 255 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Double (Participant, Investigator) |
| Primary Purpose: | Treatment |
| Official Title: | A Double-Blind, Parallel, Randomized, Placebo Controlled Trial to Evaluate Onset of Action of Loratadine and Fexofenadine in Subjects With Seasonal Allergic Rhinitis in a Pollen Challenge Chamber |
| Study Start Date : | October 2011 |
| Actual Primary Completion Date : | November 2011 |
| Actual Study Completion Date : | November 2011 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: loratadine
Participants will receive one dose of loratadine following randomization at 120 minutes of exposure during visit 4.
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Drug: loratadine
loratadine, one 10 mg tablet, orally
Other Name: SCH 029851
Drug: placebo to fexofenadine
one tablet, orally
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Experimental: fexofenadine
Participants will receive one dose of fexofenadine following randomization at 120 minutes of exposure during visit 4.
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Drug: fexofenadine
fexofenadine, one 180 mg tablet, orally
Drug: placebo to loratadine
one tablet, orally
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Placebo Comparator: placebo
Participants will receive one dose of placebo following randomization at 120 minutes of exposure during visit 4.
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Drug: placebo to loratadine
one tablet, orally
Drug: placebo to fexofenadine
one tablet, orally
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- Mean Major Symptom Complex (MSC) Score by Post-Treatment Evaluation Time Point (From 180 Minutes to 300 Minutes) [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]The MSC Score is calculated as the sum of 5 individual symptom scores for Runny Nose, Itchy Nose, Sneezing, Watery Eyes, and Itchy Eyes. Each individual symptom is rated on a 5-point scale of severity: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The total MSC score ranges from 0 - 25. Increasing scores are associated with increasing severity.
- Mean Individual Symptom Score for Runny Nose by Post-Treatment Evaluation Time Point [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]
The individual symptom score for Runny Nose was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Runny Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
- Mean Individual Symptom Score for Itchy Nose by Post-Treatment Evaluation Time Point [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]
The individual symptom score for Itchy Nose was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Nose symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
- Mean Individual Symptom Scores for Sneezing by Post-Treatment Evaluation Time Point [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]
The individual symptom score for Sneezing was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Sneezing symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
- Mean Individual Symptom Scores for Watery Eyes by Post-Treatment Evaluation Time Point [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]
The individual symptom score for Water Eyes was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Watery Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
- Mean Individual Symptom Scores for Itchy Eyes by Post-Treatment Evaluation Time Point [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]
The individual symptom score for Itchy Eyes was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Eyes symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
- Mean Individual Symptom Scores for Nasal Congestion by Post-Treatment Evaluation Time Point [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]
The individual symptom score for Nasal Congestion was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Nasal Congestion symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
- Mean Individual Symptom Scores for Itchy Mouth/Throat/Ears by Post-Treatment Evaluation Time Point [ Time Frame: From time of sensitization (time 0) to end of visit (~8 hours) ]
The individual symptom score for Itchy Mouth/Throat/Ears was rated on a 5-point
scale of severity using the following scale: 0 = None (No symptoms), 1 = MILD (Symptom is present, but easily tolerated), 2 = MODERATE (Awareness of symptoms, bothersome, but tolerable), 3 = SEVERE (Definite awareness of symptoms, difficult to tolerate but does not interfere with activities), 4 = VERY SEVERE (Difficult to tolerate and interferes with the activities of daily living). The Itchy Mouth/Throat/Ears symptom score ranges from 0 - 5. Increasing scores are associated with increasing severity.
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| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Female participants of child bearing potential must demonstrate a negative
urine pregnancy test at Screening (Visit 1) and Visit 4 (prior to randomization) and agree to use (and/or have their partner use) 2 acceptable methods of birth control beginning at the Screening visit and throughout the study.
- Willing to stop use of current decongestant and allergy medications at the start of the washout period (Visit 1) and during the trial.
- Documented history or participant-reported history of seasonal allergic rhinitis caused by mountain cedar pollen within the last 2 years and documented or participant-reported symptoms over at least the last 2 mountain cedar allergy seasons.
- Documented skin testing (prick with wheal ≥ 4 mm larger than the diluent) within the last 1 year to mountain cedar pollen present.
- Capable of reading English.
- Body mass index (BMI) <35.
Exclusion Criteria:
- Any significant medical condition which, in the judgment of the investigator, is a contraindication to the use of loratadine, fexofenadine or might interfere with the trial. These may include thyroid disease (e.g., hyperthyroidism, hypothyroidism), uncontrolled diabetes mellitus, coronary heart disease, ischemic heart disease, elevated intraocular pressure, prostatic hypertrophy.
- Have started allergen immunotherapy within 1 month preceding enrollment or participants starting allergen immunotherapy or anticipating immunotherapy dose change during the trial. Xolair (omalizumab) may not be used within 4 years prior to trial participation.
- Known allergy or intolerance to loratadine, desloratadine, or fexofenadine.
- History of rhinitis medicamentosa.
- Use of systemic (oral, rectal, injectable), topical (up to 1% topical hydrocortisone is permitted), or nasal corticosteroids in the last 30 days or current or expected use of disallowed medications as listed in the protocol.
- Asthma, with the exception of mild intermittent asthma.
| Responsible Party: | Bayer |
| ClinicalTrials.gov Identifier: | NCT01469234 History of Changes |
| Other Study ID Numbers: |
18126 PT11-37 ( Other Identifier: Consumer Health Care ) P08712 ( Other Identifier: Merck ) |
| First Posted: | November 10, 2011 Key Record Dates |
| Results First Posted: | March 22, 2013 |
| Last Update Posted: | March 11, 2015 |
| Last Verified: | February 2015 |
Additional relevant MeSH terms:
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Rhinitis Rhinitis, Allergic Rhinitis, Allergic, Seasonal Nose Diseases Respiratory Tract Diseases Respiratory Tract Infections Otorhinolaryngologic Diseases Respiratory Hypersensitivity Hypersensitivity, Immediate Hypersensitivity Immune System Diseases Fexofenadine |
Loratadine Terfenadine Anti-Allergic Agents Histamine H1 Antagonists, Non-Sedating Histamine H1 Antagonists Histamine Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs Antipruritics Dermatologic Agents |