Efficacy and Safety of AM-301 on Allergic Symptoms of Perennial Allergic Rhinitis Sufferers

Altamira Medica

Status: Completed

Conditions: Perennial Allergic Rhinitis; Rhinitis, Allergic

Treatments: Device: Treatment A; Other: Treatment C; Device: Treatment B

Study type: Interventional

Funder types: Industry

Identifiers

NCT05122143

AM-301-CL-21-02

Details and patient eligibility

About

Alleviation of allergic symptoms induced by house dust mites when using the medical device AM-301.

This clinical investigation explored the efficacy and safety of AM-301 when used to reduce symptoms of house dust mite sufferers. The primary objective was to compare the efficacy of AM-301 Device between treated and non-treated subjects in the treatment of perennial allergic rhinitis (PAR).

Full description

This was a randomized, open-label, 3-period crossover study. The total study duration was approximately 65 days and consisted of 2 screening visits and 3 treatment visits (total 5 visits) followed by a telephone call. Patients with HDM allergy as assessed by their medical history and a positive skin prick test for Dermatophagoides pteronyssinus (der p) allergen were enrolled into the screening phase.

At least 7 days after the second screening visit, the treatment visits started. Eligible subjects were randomized to one of the six treatment sequences (ABC, BCA, CAB, ACB, BAC, CBA) at an equal ratio. The treatments were applied 10 minutes before the challenge at Visit 3, 4 and 5:

• Treatment A: One spray AM-301 (0.14 mL) per nostril,
• Treatment B: Two sprays AM-301 (0.28 mL) per nostril (at two defined spray angles in order to obtain a broader coverage of the nasal mucosa),
• Treatment C: no treatment.

The cross-over design allowed treatment C to be used as internal control. Between the three treatment visits in the chamber there was a 7±2 days wash-out period.

Enrollment: 37 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Main Inclusion Criteria:

• Body mass index between 18.0 and 32.0 kg/m2 inclusive.
• History of perennial allergic rhinitis to house dust mite for more than 1 year.
• Positive Skin Prick Test (SPT) for Dermatophagoides pteronyssinus (der p) allergen at screening or within 12 months prior to the screening visit.

Main Exclusion Criteria:

• Any clinically relevant abnormal findings in physical examination, clinical chemistry, hematology, urinalysis, vital signs, lung function at screening visit, which, in the opinion of the investigator, may either put the subject at risk because of participation in the study or may influence the results of the study, or the subject's ability to participate in the study.
• Use of any medication considered to have an influence on the outcome of the study during the EEC session, at the discretion of the Investigator and/or designee.
• Recent nasal ulcers, mucosal erosion, nasal surgery, or nasal trauma, that might interfere with study results as determined by the Investigator and/or designee.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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37 participants in 6 patient groups

Sequence 1

Experimental group

Description:

Treatment sequence for the 3 treatment exposure visits is ABC.

Treatment:

Device: Treatment B

Other: Treatment C

Device: Treatment A

Sequence 2

Experimental group

Description:

Treatment sequence for the 3 treatment exposure visits is BCA.

Treatment:

Device: Treatment B

Other: Treatment C

Device: Treatment A

Sequence 3

Experimental group

Description:

Treatment sequence for the 3 treatment exposure visits is CAB.

Treatment:

Device: Treatment B

Other: Treatment C

Device: Treatment A

Sequence 4

Experimental group

Description:

Treatment sequence for the 3 treatment exposure visits is ACB.

Treatment:

Device: Treatment B

Other: Treatment C

Device: Treatment A

Sequence 5

Experimental group

Description:

Treatment sequence for the 3 treatment exposure visits is BAC.

Treatment:

Device: Treatment B

Other: Treatment C

Device: Treatment A

Sequence 6

Experimental group

Description:

Treatment sequence for the 3 treatment exposure visits is CBA.

Treatment:

Device: Treatment B

Other: Treatment C

Device: Treatment A