E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal allergic rhinitis |
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E.1.1.1 | Medical condition in easily understood language |
Allergy to pollen |
Pollenallergi |
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E.1.1.2 | Therapeutic area | Diseases [C] - Respiratory Tract Diseases [C08] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 19.0 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039776 |
E.1.2 | Term | Seasonal allergic rhinitis |
E.1.2 | System Organ Class | 100000004870 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
The primary objective is to assess the effect of a topical PPS formulation on post-challenge nasal symptoms using an allergen challenge model in subjects with seasonal allergic rhinitis. |
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E.2.2 | Secondary objectives of the trial |
• Assess the effect of a topical PPS formulation on morning and evening nasal symptoms in subjects with seasonal allergic rhinitis using the allergen challenge model
• Assess the effect of a topical PPS formulation on peak nasal inspiratory flow (PNIF) in subjects with seasonal allergic rhinitis using the allergen challenge model
• Assess the safety and tolerability of a topical PPS formulation in subjects with seasonal allergic rhinitis undergoing allergen challenge
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects have to meet all of the following criteria to be eligible to enter the study: 1) Willingness and ability to provide written informed consent and adhere to study procedures
2) Male or female, in good general health
3) Age 18 to 65 years
4) Seasonal allergic rhinitis for at least 2 years prior to screening
5) Positive skin prick test for birch and/or grass pollen allergen at screening or in the previous 12 months (as documented in the subject’s medical records)
6) Absence of symptoms outside the pollen season
7) Need for treatment upon seasonal allergen exposure
8) Positive response to allergen challenge during nasal titration (5 sneezes or a symptom score of 2 or more on a scale of 0 to 3 for either nasal secretion or nasal congestion)
9) Ability to speak, read and otherwise understand Swedish
10) Agreement to use adequate contraceptive measures:
Female subjects who (i) have been post-menopausal for more than 1 year, (ii) have been sterilised or
(iii) agree to use a highly effective method of contraception (i.e. a method with a failure rate of less than 1% [e.g. oral contraceptives, hormone implants, hormone injections, some intrauterine devices or vasectomised partner]) from screening until 28 days after the last dose of investigational medicinal product (IMP)
Male subjects who (i) agree to use condoms from screening until 28 days after the last dose of IMP or
(ii) have a partner who is using a highly effective method of contraception, as described above |
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E.4 | Principal exclusion criteria |
Subjects meeting any of the following criteria will not be permitted to enter the study:
1) Any disease that would compromise subject safety or data validity, as judged by the Investigator
2) Symptomatic perennial allergic rhinitis
3) Asthma (except for completely-resolved childhood asthma, with no symptoms for >5 years)
4) Clinically relevant structural nasal abnormalities, as judged by the Investigator
5) Clinical signs and symptoms of active infection, including any acute or chronic respiratory tract infection in the 2 weeks prior to the first day of treatment period 1 (treatment period 1 may be deferred in such circumstances at the discretion of the Investigator)
6) Use of inhaled or systemic corticosteroids in the 4 weeks prior to day 1 of treatment period 1
7) Use of anti-histamines in the week prior to day 1 of treatment period 1
8) Previous immunotherapy as a treatment intervention for allergic rhinitis, including monoclonal antibody therapy (lifetime history), as judged by the Investigator
9) Use of any other prescription, non-prescription (over-the-counter) or complementary medicines within 14 days prior to day 1 of treatment period 1 (except occasional use of paracetamol [up to 2 g per day] or hormonal contraceptives) that would compromise subject safety or data validity, as judged by the Investigator
10) Known hypersensitivity or allergy to PPS, chemically related products or any of the excipients
11) History of alcohol or substance abuse, as judged by the Investigator
12) Positive viral test result for hepatitis B or C or HIV 1 or 2
13) APTT outside the normal range at screening
14) Female subjects: current breast-feeding or intention to become pregnant within 28 days after the last IMP dose
15) Participation in another clinical trial in the previous month or less than 5 half-lives since an IMP was last administered in another clinical trial, or plans to enter another clinical trial during enrolment in this clinical trial
16) Being a family member of any employee of the Investigator and/or Sponsor with direct involvement in the study |
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary endpoint is mean post-challenge TNSS over the last 3 days of allergen challenge (treatment days 12 to 14). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
• Mean morning and evening TNSS over the last 3 days of allergen challenge (treatment days 12 to 14)
• Mean scores for individual nasal symptoms (nasal secretion, nasal congestion, sneezing and nasal itching) over the last 3 days of allergen challenge
• Mean PNIF over the last 3 days of allergen challenge
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Exploratory: To analyse the effect of a topical PPS formulation on the immune response in subjects with seasonal allergic rhinitis who are exposed to allergen challenge. |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 5 |
E.8.9.1 | In the Member State concerned days | 0 |