A Phase 3 interventional study of Placebo and azelastine Hcl in Seasonal Allergic Rhinitis, sponsored by Meda Pharmaceuticals. Completed at 43 sites in United States. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2012-09-26.
Sponsored by Meda Pharmaceuticals · Phase 3, Interventional, and Treatment
The purpose of this study is to determine if two allergy medications (azelastine and fluticasone) are more effective than placebo or either medication alone (azelastine or fluticasone)
This will be a Phase III, randomized, double-blind, placebo-controlled, parallel-group study in subjects with moderate-to-severe seasonal allergic rhinitis (SAR). The study will begin with a 7-day, single-blind, placebo lead-in period (Day -7 to Day 1). Subjects will be instructed to take placebo lead-in medication twice daily (1 spray per nostril), approximately every 12 hours. On Day 1, subjects who satisfy the symptom severity requirements and continue to meet all of the study inclusion/exclusion criteria will be randomized in a 1:1:1:1 ratio to receive 1 spray per nostril twice daily of MP29-02, azelastine hydrochloride, fluticasone propionate, or placebo nasal spray.
Efficacy will be assessed by the change from baseline in the subject-reported 12-hour reflective Total Nasal Symptom Score (TNSS). On Days 1 through 14, subjects will rate the instantaneous and reflective TNSS symptoms of sneezing, nasal congestion, runny nose, and nasal itching; the instantaneous and reflective total ocular symptom score (TOSS) symptoms of itchy eyes, watery eyes and eye redness; and the symptom of postnasal drip, twice daily (AM and PM) in a diary prior to the dose of study medication. Symptoms will be scored on a 0 to 3 scale (0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms, 3 = severe symptoms), such that the maximum daily symptom severity score will be 24 for the TNSS and 18 for the TOSS. Additional secondary efficacy variables will include reflective individual nasal and ocular symptom scores, as well as change from Baseline to Day 14 in the Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ).
Subjects ≥ 18 years of age will complete the RQLQ on Day 1 (prior to dosing) and Day 14. Subjects will return to the clinic on Day 7 for an interim evaluation. After completing the 2-week double-blind treatment period, subjects will return to the clinic on Day 14 (or at time of early termination) for an end-of-study evaluation. Safety and tolerability assessments will be made on Days 7 and 14. Tolerability will be evaluated by subject-reported adverse events (AEs), nasal examinations, and vital signs assessments.
1,105 studies on the registry are indexed under Rhinitis; 65 are open to participants now.
This study's enrollment of 832 is above the median of 89 across 906 interventional studies indexed under Rhinitis.
Browse Rhinitis studies →Meda Pharmaceuticals is the lead sponsor of 19 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion criteria:
Drug: fluticasone propionate
Drug: azelastineHcl / fluticasone propionate
Drug: Placebo
Drug: azelastine Hcl
placebo
azelastine Hcl 548 mcg
Also known as: azelastine
azelastine Hcl 548 mcg / fluticasone propionate 200 mcg
Also known as: MP29-02
fluticasone propionate 200 mcg
Also known as: fluticasone
Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS)
change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.
Time frame: days 1 to 14
Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS)
change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result.
Time frame: day 1 to day 14
Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days
adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14. The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result.
Time frame: day 1 to day 14
| Milestone | MP29-02 | Fluticasone Propionate | Azelastine HCl | Placebo |
|---|---|---|---|---|
| Started | 207 | 207 | 208 | 210 |
| Completed | 198 | 200 | 197 | 203 |
| Not completed | 9 | 7 | 11 | 7 |
| Withdrew: Adverse event | 4 | 0 | 1 | 1 |
| Withdrew: Protocol violation | 2 | 2 | 6 | 2 |
| Withdrew: Lost to follow-up | 2 | 0 | 1 | 2 |
| Withdrew: Administrative | 1 | 4 | 2 | 1 |
| Withdrew: Withdrawal by subject | 0 | 1 | 1 | 1 |
change from baseline in 12-hour reflective(how did you feel in the last 12 hours) total nasal symptom score (rTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative value the better the result.
| units on a scale | MP29-02 | Fluticasone Propionate | Azelastine HCl | Placebo |
|---|---|---|---|---|
| Change From Baseline in 12-hour Reflective Total Nasal Symptom Score (rTNSS) | -5.6 ± 5.2 | -4.7 ± 4.7 | -4.2 ± 4.6 | -2.9 ± 3.9 |
change from baseline in 12-hour instantaneous ( how do you feel now) total nasal symptom score (iTNSS)consisting of nasal congestion,runny nose, itchy nose and sneezing scored twice daily (AM and PM) in diary cards for the entire 14 day study period. The measurement scale is 0 to 24.A reduction in symptom severity score is indicated by a negative value.The more negative the value the better the result.
| units on a scale | MP29-02 | Fluticasone Propionate | Azelastine HCl | Placebo |
|---|---|---|---|---|
| Change From Baseline in 12 Hour Instantaneous Total Nasal Symptom Score (iTNSS) | -5.2 ± 5.3 | -4.5 ± 4.7 | -4.0 ± 4.7 | -2.6 ± 4.1 |
adult Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ) scored at day 1(baseline) and at day 14. The scale is measured from a value of 0 to 24. A negative number corresponds to a change from baseline measurement.The more negative the value the better the result.
| units on a scale | MP29-02 | Fluticasone Propionate | Azelastine HCl | Placebo |
|---|---|---|---|---|
| Change From Baseline in Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ)at the End of 14 Days | -1.6 ± 1.4 | -1.6 ± 1.2 | -1.4 ± 1.1 | -0.9 ± 1.1 |
Non-serious events are listed at a 1.0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| MP29-02 | — | 0/207 (0%) | 12/207 (5.8%) |
| Fluticasone Propionate | — | 0/207 (0%) | 16/207 (7.7%) |
| Azelastine HCl | — | 0/208 (0%) | 19/208 (9.1%) |
| Placebo | — | 0/210 (0%) | 7/210 (3.3%) |
| Event | MP29-02 | Fluticasone Propionate | Azelastine HCl | Placebo |
|---|---|---|---|---|
| dysgusiaGastrointestinal disorders | 5/207 | 2/207 | 7/208 | 1/210 |
| epistaxisRespiratory, thoracic and mediastinal disorders | 2/207 | 5/207 | 4/208 | 2/210 |
| headacheNervous system disorders | 1/207 | 5/207 | 1/208 | 3/210 |
| nasal discomfortRespiratory, thoracic and mediastinal disorders | 2/207 | 2/207 | 4/208 | 0/210 |
| nauseaGastrointestinal disorders | 1/207 | 2/207 | 1/208 | 0/210 |
| sneezingRespiratory, thoracic and mediastinal disorders | 1/207 | 0/207 | 2/208 | 1/210 |
| Age, Categorical(Participants) | MP29-02 | Fluticasone Propionate | Azelastine HCl | Placebo | Total |
|---|---|---|---|---|---|
| <=18 years | 19 | 15 | 28 | 36 | 98 |
| Between 18 and 65 years | 183 | 185 | 172 | 166 | 706 |
| >=65 years | 5 | 7 | 8 | 8 | 28 |
| Age Continuous(years) | MP29-02 | Fluticasone Propionate | Azelastine HCl | Placebo | Total |
|---|---|---|---|---|---|
| Mean | 37.3 ± 14.1 | 38.6 ± 14.1 | 36.2 ± 14.6 | 37.3 ± 16.0 | 37.3 ± 14.7 |
| Sex: Female, Male(Participants) | MP29-02 | Fluticasone Propionate | Azelastine HCl | Placebo | Total |
|---|---|---|---|---|---|
| Female | 142 | 127 | 130 | 133 | 532 |
| Male | 65 | 80 | 78 | 77 | 300 |
| Region of Enrollment(participants) | MP29-02 | Fluticasone Propionate | Azelastine HCl | Placebo | Total |
|---|---|---|---|---|---|
| United States | 207 | 207 | 208 | 210 | 832 |
This study is completed, as verified in Aug 2012. You cannot join it, but the record below documents what was studied.
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Meda Pharmaceuticals