Study of Nasonex in the Relief of Nasal Congestion in Patients With Seasonal Allergic Rhinitis
- Conditions
- SEASONAL ALLERGIC RHINITIS (SAR)Therapeutic area: Diseases [C] - Respiratory Tract Diseases [C08]
- Registration Number
- EUCTR2014-004919-36-Outside-EU/EEA
- Lead Sponsor
- Schering-Plough Research Institute, a Division of Schering Corporation
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- A
- Sex
- All
- Target Recruitment
- 351
1. A subject must have been 12 years of age or older, of either sex, and of any race.
2. A subject must have had at least a 2-year history of SAR which exacerbated during the study season.
3. A subject must have had a positive skin prick test response to an appropriate seasonal allergen at Visit 1.
4. A subject must have been clinically symptomatic at the Screening Visit. The following reflective (PRIOR) scores, as assessed by the subject, must have been attained: nasal congestion score =2 and TNSS =6. In addition, the overall evaluation of SAR, as assessed by the subject, must have been =2.
5. A subject must have been clinically symptomatic at the Baseline Visit. The total of the seven run-in diary reflective (PRIOR) scores for the 3 days prior to Baseline and the AM of the Baseline Visit must have been: nasal congestion score =14 and TNSS =42.
6. A subject must have been in general good health as confirmed by routine clinical and laboratory testing and electrocardiogram (ECG) results. All laboratory tests must have been within normal limits or clinically acceptable to the investigator and sponsor.
7. A subject must have been free of any clinically significant disease, other than seasonal allergic rhinitis, which could have interfered with the study evaluations.
8. A subject and/or parent/guardian must have been willing to give written informed consent and must have been able to adhere to dosing and visit schedules and meet study requirements.
9. In a female subject of childbearing potential, the serum pregnancy test (human chorionic gonadotropin [hCG]) must have been negative at Screening. Nonsterile and premenopausal female subjects must have been using a medically acceptable method of birth control, ie, double-barrier method, or systemic contraceptive prior to Screening and during the study.
10. A female subject of child-bearing potential who was not sexually active must have agreed to use a medically accepted method of contraception if she became sexually active while participating in the study.
Are the trial subjects under 18? yes
Number of subjects for this age range: 25
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 318
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 8
1. A subject whose ability to provide informed consent was compromised.
2. A subject with a history of noncompliance with medications or treatment protocols.
3. A subject with a history of severe local reaction(s) or anaphylaxis to skin testing.
4. A subject who received any prohibited medication more recently than the indicated washout period prior
to Screening, or who continued to receive prohibited medication as defined in the protocol.
5. A subject with significant medical condition(s) that, in the judgment of the investigator, might interfere with the study or require treatment.
6. A subject who had an upper respiratory tract or sinus infection that required antibiotic therapy without at least a 14-day washout prior to the Screening Visit, or who had a viral upper respiratory infection within 7 days prior to the Screening Visit.
7. A subject who used any drug in an investigational protocol in the 30 days prior to the Screening Visit.
8. A subject who was participating in any other clinical study.
9. A subject who was part of the staff personnel directly involved with this study.
10. A subject who was a family member (parent, spouse, or sibling) of the investigational study staff.
11. A female subject who was breast-feeding, pregnant, or intended to become pregnant.
12. A subject previously randomized into this study.
13. A subject who had a family member (parent, spouse, or sibling) currently enrolled in this study.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study was to assess the efficacy in relieving the symptom of nasal<br>congestion with MFNS 200 mcg given once daily compared to placebo in subjects with symptomatic SAR.<br>;Secondary Objective: The key secondary objective of this study was to assess the efficacy of MFNS in improving total nasal symptom score (TNSS). An additional secondary objective was the assessment of the overall condition of SAR.;Primary end point(s): The primary efficacy endpoint was the change from Baseline in average AM/PM PRIOR nasal congestion score averaged over Days 1 to 15.;Timepoint(s) of evaluation of this end point: From the Baseline Visit afterwards, and throughout the remainder of the study, the subjects were to complete a diary twice daily and evaluate these symptoms both as NOW and as PRIOR assessments.
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Change from Baseline in average AM/PM PRIOR TNSS averaged over Days 1 to 15.;Timepoint(s) of evaluation of this end point: From the Baseline Visit afterwards, and throughout the remainder of the study, the subjects were to complete a diary twice daily and evaluate these symptoms both as NOW and as PRIOR assessments.