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This study aims to evaluate the effectiveness and safety of ALDP001 Nasal Spray in treating seasonal allergic rhinitis, and to identify the optimal dosage and administration frequency for this formulation.
The study will be conducted in two Parts. In Part A, participants will receive a once-daily (OD) dose of the nasal spray for eight days. An interim analysis will then be performed to identify the optimal dose for the next part. In Part B, participants will be administered a twice-daily (BD) dose of the selected formulation from Part A to evaluate the appropriate dosing frequency for the regimen.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALDP001 0.125% w/v | Experimental | Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days |
|
| ALDP001 (0.25% w/v) | Experimental | Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days |
|
| ALDP001 (0.5% w/v) Nasal Spray | Experimental | Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days |
|
| Placebo Nasal Spray | Placebo Comparator | Participants will self-administer one spray in each nostril, either once or twice daily, using the assigned nasal spray kit for a duration of eight days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALDP001 Nasal Spray | Drug | Experimental Arm |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline in Total Nasal Symptom Score | Total Nasal Symptom Score (TNSS) is calculated by summing scores from four nasal symptoms: itchy nose, nasal congestion, runny nose, and sneezing. Each symptom is rated on a scale from 0 to 3, where: 0 - None (no symptoms)
The total score ranges from 0 to 12. Participants will record TNSS at multiple timepoints: 0, 30, 60, 90, 120, 180, and 240 minutes, both at baseline and after 8 days of treatment. The change from baseline (CFB) at each timepoint will be calculated and compared between study arms to evaluate the treatment effect of ALDP001 Nasal Spray. | Day 9 |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in the Area Under the Curve of the Total Nasal Symptom Score at Day 9 | The Area Under the Curve (AUC) for the Total Nasal Symptom Score (TNSS) will be calculated based on measurements taken at multiple timepoints: 0, 30, 60, 90, 120, 180, and 240 minutes, both at baseline and after 8 days of treatment. The TNSS is a composite score assessing nasal symptoms including congestion, rhinorrhea, itching, and sneezing. Each symptom is rated on a scale from 0 (no symptoms) to 3 (severe symptoms), resulting in a total score range of 0 to 12, where higher scores indicate worse nasal symptoms. The change from baseline in the AUC for TNSS after the treatment period will be analyzed and compared across study arms to assess the efficacy of the intervention. A lower AUC value indicates better symptom control, and the AUC is expected to be lowest for the optimum dose group, reflecting improved treatment efficacy. The change from baseline in AUC of the TNSS for each dose group will be analyzed to identify the optimum dose. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with Adverse events (AEs), with abnormal Clinical Laboratory Parameters, abnormal ECG readings | The number of participants who experience adverse events (AEs), as well as those presenting with abnormal clinical laboratory parameters (including hematology, biochemistry, and urinalysis) and abnormal ECG findings (such as QT interval prolongation), will be recorded and analyzed to evaluate the safety profile of the investigational product. |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Akhilesh Sharma | Contact | +912239829999 | akhilesh.sharma@alkem.com | |
| Yogesh Rane | Contact | +919820587254 | yogesh.rane@alkem.com |
| Name | Affiliation | Role |
|---|---|---|
| Patricia Couroux, MD | Cliantha Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cliantha Research | Recruiting | Mississauga | Ontario | Canada |
masked Lab reports, masked Total Nasal symptom Score etc
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Double blind pharmacy controlled randomization
| Placebo Nasal spray | Drug | Controlled arm |
|
| Day 9 |
| From enrollment to End of Study i.e. 10 days |
| ID | Term |
|---|---|
| D006255 | Rhinitis, Allergic, Seasonal |
| ID | Term |
|---|---|
| D065631 | Rhinitis, Allergic |
| D012220 | Rhinitis |
| D009668 | Nose Diseases |
| D012140 | Respiratory Tract Diseases |
| D012130 | Respiratory Hypersensitivity |
| D010038 | Otorhinolaryngologic Diseases |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |
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