Phase 4
Completed N=418
Compare the Efficacy of Levocetirizine and Montelukast to Placebo in Reducing Seasonal Allergic Rhinitis (SAR) Symptoms in Ragweed Sensitive Subjects
Rhinitis, Allergic, Seasonal
Source: ClinicalTrials.gov NCT00295022 ↗
Enrolled (actual)
418
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I — -3.46; -6.58; -5.65 units on a scale — p=<0.001
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
To compare the clinical efficacy of levocetirizine 5 mg and montelukast 10 mg on symptoms of seasonal allergic rhinitis occurring in subjects exposed to ragweed pollen in an environmental exposure unit.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in the Major Symptom Complex (MSC) Score Over Period I |
-3.46; -6.58; -5.65 | <0.001 sig |
| SECONDARY Change From Baseline in the MSC Score Over Period II |
-1.22; -6.35; -3.24 | — |
| SECONDARY Change From Baseline in the MSC Score Over Period III |
-3.50; -8.62; -6.19 | — |
| SECONDARY Change From Baseline in the MSC Score Over the Total Treatment Period (Period I + Period II + Period III) |
-3.16; -7.37; -5.48 | — |
| SECONDARY Change From Baseline in the Total Symptom Complex (TSC) Score Over Period I |
-6.16; -10.53; -9.01 | — |
| SECONDARY Change From Baseline in the Total Symptom Complex (TSC) Score Over Period II |
-2.45; -9.54; -5.12 | — |
| SECONDARY Change From Baseline in the Total Symptom Complex (TSC) Score Over Period III |
-5.91; -13.39; -9.73 | — |
| SECONDARY Change From Baseline in the Total Symptom Complex (TSC) Score Over the Total Treatment Period (Period I + Period II + Period III) |
-5.53; -11.54; -8.68 | — |
| SECONDARY Change From Baseline in the TSC Score + Nasal Congestion Score Over Period I |
-6.57; -11.15; -9.65 | — |
| SECONDARY Change From Baseline in the TSC Score + Nasal Congestion Score Over Period II |
-2.65; -9.97; -5.47 | — |
| SECONDARY Change From Baseline in the TSC Score + Nasal Congestion Score Over Period III |
-6.35; -14.18; -10.39 | — |
| SECONDARY Change From Baseline in the TSC Score + Nasal Congestion Score Over the Total Treatment Period (Period I + Period II + Period III) |
-5.92; -12.21; -9.28 | — |
| SECONDARY Change From Baseline in the Individual Symptom Scores Over Period I |
-0.55; -0.89; -0.86; -0.52; -0.93; -0.85 | — |
| SECONDARY Change From Baseline in the Individual Symptom Scores Over Period II |
-0.18; -0.85; -0.53; -0.22; -0.84; -0.40 | — |
| SECONDARY Change From Baseline in the Individual Symptom Scores Over Period III |
-0.52; -1.23; -0.93; -0.47; -1.25; -0.89 | — |
| SECONDARY Change From Baseline in the Individual Symptom Scores Over the Total Treatment Period (Period I + Period II + Period III) |
-0.48; -1.02; -0.84; -0.46; -1.05; -0.79 | — |
| SECONDARY Time to First Feeling of Improvement During Period I |
101.02; 70.02; 63.02 | — |
| SECONDARY Onset of Action During Period I |
NA; 1.5; 1.5 | — |
| SECONDARY Intensity of Action From Baseline in the MSC Score Over Period I |
54.3; 21.0; 32.7; 45.7; 79.0; 67.3 | — |
| SECONDARY Intensity of Action From Baseline in the MSC Score Over Period II |
67.3; 32.1; 53.6; 32.7; 67.9; 46.4 | — |
| SECONDARY Intensity of Action From Baseline in the MSC Score Over Period III |
48.1; 16.7; 31.8; 51.9; 83.3; 68.2 | — |
| SECONDARY Variability of Action From Baseline in the MSC Score Over Period I |
54.3; 21.0; 32.7; 15.2; 22.9; 19.2 | — |
| SECONDARY Variability of Action From Baseline in the MSC Score Over Period II |
67.3; 32.1; 53.6; 17.3; 19.2; 16.6 | — |
| SECONDARY Variability of Action From Baseline in the MSC Score Over Period III |
48.1; 16.7; 31.8; 21.2; 17.9; 14.6 | — |
| SECONDARY Global Satisfaction of the Subjects at the End of Period III |
32.42; 53.94; 41.80 | — |
| SECONDARY Percentage of Subjects, at the End of Period III Who Are Willing to Take the Same Medication During the Next Pollen Season |
23.1; 49.4; 32.9 | — |
Eligibility Criteria
Inclusion Criteria
- Have had seasonal allergic rhinitis due to Ragweed for the last 2 consecutive years
- Subjects who obtain a minimum sum score, considering Seasonal Allergic Rhinitis (SAR) related symptoms (mean value), as defined by the protocol
Exclusion Criteria
- Any clinically significant condition that might interfere with the treatment evaluation, both for efficacy and safety
- Have used forbidden concomitant medications as defined by the protocol
Data sourced from ClinicalTrials.gov (NCT00295022). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.