E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
persistent allergic rhinitis and concomitant intermittent asthma |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10039085 |
E.1.2 | Term | Rhinitis allergic |
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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 of this study is to explore the efficacy of mometasone furoate nasal spray in comparison with placebo in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by the Rhinasthma Questionnaire (Global Summary Score). |
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E.2.2 | Secondary objectives of the trial |
There are 2 secondary objectives. The first secondary objective is to evaluate the efficacy of mometasone furoate nasal spray in improving the quality of life of subjects with moderate-severe PER and intermittent asthma as measured by: the Rhinasthma Upper Airways Score; the Rhinastma Lower Airways Score; the Rhinasthma Respiratory Allergy Impact Score. The second secondary objective is to evaluate the efficacy of mometasone furoate nasal spray in relieving the subjects symptoms of allergic rhinitis and asthma as measured by: the Total 5 Symptoms score (T5SS) and the Global Symptom Score (T5SS+asthma symptoms); the use of rescue medication on demand. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Subjects must be outpatients ( 18 and ≤ 75 years of age) of either sex. Subjects must demonstrate willingness to participate in the study and comply with its procedures by signing a written informed consent. Subjects must have moderate/severe persistent allergic rhinitis with a history of intermittent asthma from at least 2 years and actual asthma (symptoms in the last 4 weeks). The diagnosis of moderate-severe persistent rhinitis will be made on a clinical basis, according to the Allergic Rhinitis and its Impact on Asthma (ARIA) criteria. The diagnosis of intermittent asthma will be based on the criteria of the Global Initiative for Asthma (GINA) guideline). In order for a subject to qualify at the randomization visit (visit 2) the daily average of the T5SS [(Morning-time T5SS + Evening-time T5SS)/2] must be ≥ 6 in at least 4 days during the 1 week run-in period. A positive (weal diameter >3 mm) skin prick test (SPT) and/or CAP-RAST (class II or higher) performed in the 6 months prior to the start of the trial are required for at least house dust mite and 1 pollen allergen (grass or Parietaria, IgE level >3.5 U/mL). The SPTs should have been performed with a standard panel of allergens common in our region, including the following: dust mites, grasses, parietaria, birch, alder, olive, cypress, cat, dog, Alternaria and Aspergillus. Subjects must confirm that all prior medication washout times have been observed (see Section 6.2); Female volunteers of childbearing potential (including women who are less than 1 year postmenopausal and women who will be sexually active during the study) must agree to use a medically accepted method of contraception or be surgically sterilized prior to screening, while receiving protocol-specified medication, and for 30 days after stopping the medication. Women who are postmenopausal for >1 year (i.e. women who have experienced 12 consecutive months of amenorrhea) will be exempted from the use of contraception during the study. Acceptable methods of contraception include condoms (male and female) with a spermicidal agent, diaphragm or cervical cap with a spermicidal agent, medically prescribed intrauterine device (IUD), oral or injectable hormonal contraceptives, and surgical sterilization (e.g., hysterectomy or tubal ligation). If subject is a female volunteer of childbearing potential, she must have a negative urine pregnancy test at Screening/Visit 1. Subjects must be free of any clinically relevant disease (other than persistent allergic rhinitis and intermittent asthma) that would interfere with study evaluations. Subjects must be able to adhere to the dosing and visit schedules, and agree to record symptom severity scores, use of IMP and rescue medications in a daily diary. |
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E.4 | Principal exclusion criteria |
1)Subject is a female who is pregnant, or intends to become pregnant during the study or within 12 weeks after study completion; 2)Subject is nursing, or intends to be nursing during the study or within 12 months after study completion; 3)Subject is currently taking medications prohibited during the study or has not complied with the requirements for the designated washout periods for any of the prohibited medications outlined in Section 6.2; 4)Subject has anatomical abnormalities of the nose (turbinate hyperthrophy, septal deviation, polyps) that would interfere with nasal airflow; 5)Subject has acute or chronic sinusitis currently being treated with antibiotics and/or topical or oral decongestants; 6)Subject has rhinitis medicamentosa; 7)Subject has evidence of persistent asthma, or asthma with daytime and night-time symptoms not controlled by short-acting beta2-adrenoceptor agonists; 8)Subjects with asthma who require chronic use of inhaled or systemic corticosteroids; 9)Subjects who have had an upper respiratory tract or sinus infection that requires antibiotic therapy and have not had at least a 14-day wash-out period prior to the run-in period, or who have had a viral upper respiratory infection within 7 days prior to screening; 10)Subject has a dependence on nasal, oral or ocular decongestants, nasal topical antihistamines, or nasal steroids; 11)Subject is currently undergoing a progressive course of immunotherapy (hyposensitization). Subjects on a regular maintenance schedule prior to the screening visit (Visit 1) and wish to remain on this schedule during the study are eligible for study inclusion; however, subject may not receive hyposensitization treatment within 24 hours prior to any study visit; 12) Subject has been diagnosed of cancer within the past 5 years (except for successfully treated basal and squamous cell carcinomas); 13) Subject has a concomitant medical problem that may interfere with participation in the study, e.g., repeated migraine episodes, uncontrolled convulsive disorders; 14) Subject has any of the following clinical conditions: active or quiescent tuberculosis infection of the respiratory tract, untreated fungal, bacterial, systemic viral infections or ocular herpes simplex; 15) Subject smokes, or is an ex-smoker who has smoked within the previous 6 months; 16) Subject is a member of the staff, is affiliated with, or is a family member of the staff personnel directly involved with this study; 17) Subject has been previously randomized into this study; 18) Subject has any other clinically significant deviation from normal in the physical examination or medical history that, in the investigators judgment, may interfere with the study evaluation or affect subject safety; 19) Subject is in a situation or condition that, in the opinion of the investigator, may interfere with optimal participation in the study; 20) Subjects who have used any drug or device in an investigational protocol in the 30 days prior to visit 1; 21) Subject is participating in any other clinical studies; 22) Subject is allergic to or has sensitivity to the study drug or its excipients; 23) Subject has compromised ability to provide informed consent; 24) Subject has a history of non-compliance with medication or treatment protocols. |
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E.5 End points |
E.5.1 | Primary end point(s) |
To evaluate the efficacy of mometasone furoate nasal spray in reducing the Rhinasthma Global Summary Score in comparison with placebo at endpoint after 28 days of treatment. |
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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 | No |
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 | Information not present in EudraCT |
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) | Yes |
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 | 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.8.3 |
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.8.4.1 | Number of sites anticipated in Member State concerned | 1 |
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 | Information not present in EudraCT |
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 | 11 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 11 |