Allergic Rhinitis. Allergic rhinitis due to pollen
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: Inclusion Criteria:1-Men and women 18 – 60 years of age; 2-Out-patients, with a history and diagnosis of allergic rhinitis for at least two years prior to Visit 1; 3-Allergy verified by a positive skin-prick test or specific IgE determination within two years prior to visit 1, or at visit 1; 4-Patients have allergic rhinitis with no response to previous local or systemic antihistamines/corticosteroids, or patients do not want these therapeutic measures or can 't be treated with these drugs due to side effects or any other reasons; 5-Patients having severe disease, where the global severity score was more than 6 in the 10 point scale in the last 3 days before enrollment; 6-Signed Informed Consent obtained from the patient prior to conducting any study-related procedures; Exclusion Criteria:1-Known light-induced skin disease (photodermatosis); 2-Ongoing fungal, viral or bacterial respiratory infection; 3-Anatomic abnormalities in the nose (eg: severe septum deviation or polyps) that disturb photo therapeutically treatment, as judged by the Investigator; 4-Prohibited Medicines such as Digoxin, Doxepin, Amiodarone, Trimethoprim , Chlorpropamide, Piroxicam, Doxycycline, Promethazine all can cause photosensitivity and Wash-Out Periods for PHOTO-SENSITIZING MEDICATIONS (eg: Systemic corticosteroids: 4 weeks; Intranasal Cromolyn, Intranasal and topical corticosteroids: 2 weeks; Intranasal decongestants: 3 days; Intranasal or systemic antihistamines: 1 week; Immunotherapy: 5 years) before beginning the study; 5-Patients less than 18 years old; 6-Pregnant women; 7-Patients unable to give informed consent because of age, mental illness, dementia or communication difficulties and patients with nasopharyngeal tumors all are excluded.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Sneezing. Timepoint: Day 0, 1, 4, 7, 9, 11, 14, 6th week , third month. Method of measurement: 0: no symptoms,1: mild, 2: medium, 3: severe.;Nasal obstruction. Timepoint: Day 0, 1, 4, 7, 9, 11, 14, 6th week , third month. Method of measurement: 0: no symptoms,1: mild, 2: medium, 3: severe.;Nasal itching. Timepoint: Day 0, 1, 4, 7, 9, 11, 14, 6th week , third month. Method of measurement: 0: no symptoms,1: mild, 2: medium, 3: severe.;Rhinorrhea. Timepoint: Day 0, 1, 4, 7, 9, 11, 14, 6th week , third month. Method of measurement: 0: no symptoms, 1: mild, 2: medium, 3: severe.;Total nasal scores. Timepoint: Day 0, 1, 4, 7, 9, 11, 14, 6th week , third month. Method of measurement: 0: no symptoms, 1: mild, 2: medium, 3: severe.;Eye smyptoms. Timepoint: Day 0, 1, 4, 7, 9, 11, 14, 6th week , third month. Method of measurement: 0: no symptoms,1: mild, 2: medium, 3: severe.;Itching of the palate,. Timepoint: Day 0, 1, 4, 7, 9, 11, 14, 6th week , third month. Method of measurement: 0: no symptoms, 1: mild, 2: medium, 3: severe.;Global severity scores questionaries. Timepoint: Day 0, 1, 4, 7, 9, 11, 14, 6th week , third month. Method of measurement: 0: no symptoms,1: mild, 2: medium, 3: severe. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1- Limited activity. Timepoint: 1- Pretreatment, 2- First month, 3- Third month. Method of measurement: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Not impaired at all: 0, severely impaired: 6.;2- Sleep. Timepoint: 1- Pretreatment, 2- First month, 3- Third month. Method of measurement: Rhinoconjunctivitis quality of life questionnaire (RQLQ) scores, Not impaired at all: 0, severely impaired: 6.;3- Non-hay fever symptoms. Timepoint: 1- Pretreatment, 2- First month, 3- Third month. Method of measurement: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Not impaired at all: 0, severely impaired: 6.;4- Practical problems. Timepoint: 1- Pretreatment, 2- First month, 3- Third month. Method of measurement: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Not impaired at all: 0, severely impaired: 6.;5- Nasal symptoms. Timepoint: 1- Pretreatment 2- First month 3- Third month. Method of measurement: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Not impaired at all: 0, severely impaired: 6.;6- Eye symptoms. Timepoint: 1- Pretreatment, 2- First month, 3- Third month. Method of measurement: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Not impaired at all: 0, severely impaired: 6.;7 - Emotional functions. Timepoint: 1- Pretreatment, 2- First month, 3- Third month. Method of measurement: Rhinoconjunctivitis Quality of Life Questionnaire (RQLQ), Not impaired at all: 0, severely impaired: 6. | — |
Countries
Iran (Islamic Republic of)
Contacts
Pediatric allergy and clinical immunology ward