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The objective of the investigation is to assess the clinical safety and effectiveness of WET® gel in the treatment of nasal dryness, following maximum two weeks of treatment.
The objective of the project is to perform a post marketing clinical study to confirm safety and clinical effectiveness of WET® gel in the treatment of nasal dryness.
This investigation will be carried out following the CE marking of the WET® gel device and is mainly intended to answer questions relating to clinical safety or performance (i.e. residual risks) of the device when used in accordance whit its approved labelling.
The study is also aimed at defining the optimal dose regimen of WET® gel.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| WET® gel | Experimental | At the screening/baseline visit (Visit 1, Day 1), eligible patients will be assigned to treatment with WET® gel, at the dose of 3-4 nasal applications/day (according to necessity), 1or 2 puff/nostril, for maximum 14 days. Treatment will be administered according to patient's need without any relation with the time of the day (i.e. day time or night time administration), however within a maximum of 4 applications/day, which must include one administration in the morning upon awakening and one administration in the evening before retiring to bed. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| WET® gel | Device | In each application, a puff should be administered in each nostril every two seconds, with minimal inspirations, up to a sensation of lubrication in the external conduct is perceived. Then the patient should proceed with short inspirations and light touching of ala of the nose, to favour the distribution of the gel. A maximum of 4 erogations (2/nostril) is allowed in each application session. |
| Measure | Description | Time Frame |
|---|---|---|
| General safety and tolerability of WET® gel | The primary objective of the investigation is to evaluate the general safety and local tolerability of WET® gel in the primary endpoint incidence of treatment-related treatment-emergent adverse events (TEAEs). Endpoint: Incidence of local and general treatment-related TEAEs during the entire investigation duration. | 15 days (the entire study duration) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in nasal dryness | Changes from baseline in score (0-10 NRS) of nasal dryness (morning, evening and daily mean) at any post-baseline time points | 15 days (the entire study duration) |
| Percentage of patients with resolution of nasal dryness |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Giordan | Fidia Farmaceutici s.p.a. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| ATS Insubria | Como | Via Varese 11 | 22100 | Italy | ||
| ATS Insubria |
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Percentage of patients with resolution of nasal dryness (defined as a score of 0 in the NRS for ≥ 3 consecutive days)
| 15 days (the entire study duration) |
| Time to resolution of nasal dryness | Time to resolution of nasal dryness (defined as a score of 0 in the NRS for ≥ 3 consecutive days) | 15 days (the entire study duration) |
| Changes from baseline of nasal crusting | Changes from baseline in score (0-10 NRS) of nasal crusting (morning, evening and daily mean) at any post-baseline time point | 15 days (the entire study duration) |
| Changes from baseline of nasal itching | Changes from baseline in score (0-10 NRS) of nasal itching (morning, evening and daily mean) at any post-baseline time point | 15 days (the entire study duration) |
| Changes from baseline of nasal burning | Changes from baseline in score (0-10 NRS) of nasal burning (morning, evening and daily mean) at any post-baseline time point | 15 days (the entire study duration) |
| Changes from baseline of nasal obstruction | Changes from baseline in score (0-10 NRS) of nasal obstruction (morning, evening and daily mean) at any post-baseline time point | 15 days (the entire study duration) |
| Compliance to treatment with WET® gel | Compliance to treatment according to patient diary | 15 days (the entire study duration) |
| Alzate Brianza |
| 22040 |
| Italy |
| ATS Insubria | Erba | 22036 | Italy |
| ATS Insubria | Porlezza | 22018 | Italy |