E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Seasonal birch pollen induced allergic rhinitis |
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E.1.1.1 | Medical condition in easily understood language |
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E.1.1.2 | Therapeutic area | Body processes [G] - Circulatory and Respiratory Physiological Phenomena [G09] |
MedDRA Classification |
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 |
To evaluate if intramuscular injected Depo-medrol 80 mg as a single dose will reduce birch pollen induced rhinitis symptoms compared to placebo (intramuscular injected NaCl). |
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E.2.2 | Secondary objectives of the trial |
To evaluate if Intramuscular injected Depo-medrol 80 mg as a single dose will reduce birch pollen induced rhinitis symptoms compared to traditional treatment with antihistamine, topical steroids and eye drops. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
- Age between 18-40.
- Severe seasonal birch pollen induced allergic rhinitis symptoms for birch verified by skin prick test.
- Signed informed consent according to IHC/GCP, and national/local regulations.
- Women of considered childbearing potential (WOCBP) will only be included after a negative highly sensitive pregnancy test according to CTFG recommendations.
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E.4 | Principal exclusion criteria |
- Pregnancy or nursing.
- Autoimmune or collagen disease.
- Cardiovascular disease.
- Hepatic disease.
- Renal disease.
- Cancer.
- Upper airway disease (non-allergic sinusitis, nasal polyposis, chronic obstructive and restrictive lung disease).
- Medication with a possible side-effect of interfering with the immune response.
- Previous immuno- or chemotherapy.
- Chronic disease.
- Major metabolic disease.
- Alcohol or drug abuse.
- Mental incapability of coping with the study.
- Known or suspected allergy to the study product.
- Suspicion of or confirmed bacterial infection.
- Known allergy to the study drugs, “rescue medication”.
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E.5 End points |
E.5.1 | Primary end point(s) |
Difference in daily symptoms score of birch pollen induced allergic rhinitis between subjects treated with a single dose Depo-medrol or NaCl, during the five week monitoring period. |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
Difference in daily symptoms during the five week monitoring period. |
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E.5.2 | Secondary end point(s) |
Number of days during when “rescue medication” was used during birch pollen season. Quality of life. Measured using the SNOT, RQLQ and ACQ5 protocols and bone turn over markers (CTX/C1NP).
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
Number of days during when “rescue medication” was used during birch pollen season. Quality of life. Measured using the SNOT, RQLQ and ACQ5 protocols pre-trial, 1 week, 3 weeks and 5 weeks after treatment is initiated. ACTH and cortisol levels pre- and post-trial.
Bone turn over markers (CTX/C1NP) pre- and post-trial
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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 | Yes |
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 | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
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) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
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 | Yes |
E.8.1.6 | Cross over | No |
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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The trial will end 5 weeks after initiated treatment or at latest 31st of May ±3 days). |
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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 | 2 |
E.8.9.1 | In the Member State concerned days | 0 |