Inclusion: diagnosed intermittent AR, during a period of exacerbation of symptoms, admissible accompanying pharmacotherapy Exclusion: pregnant and nursing women, intolerance to one of the substances, usage of other antiallergy agents, nose surgery within 6 weeks before the study, signs of bacterial disease, flu, antibacterial treatment, stomatic disease
60-day treatment Ectoine: 1-2 sprays 3 times a day INS: 2 doses once a day 4 visits
Sneezing, itching, rhinorrhea, nasal congestion, dry mucosa, cough, fatigue, eosinophils, unpleasant smell in the rhinopharynx, rhinoscopy status, video endoscopic investigation status of the nasal cavity, cytological investigation status of the nasal secretion
No AE reported for the ectoine treatment, 4 patients from the INS-alone group reported increased dryness of the nasal mucosa
Children & adolescents Age range: 5-17 Mean age: not assessed
Inclusion: diagnosed seasonal allergic rhinitis, Exclusion: AR flare-ups associated with an acute respiratory disease with increased body temperature, as well as children with an AR flare-up, atopic dermatitis, and bronchial asthma
28-day treatment (4 weeks) Ectoine: as prescribed Anti-inflammatory: as prescribed 4 visits
Rhinorrhea, paroxysmal sneezing, nasal congestion clinical manifestations of the flare-ups and the severity of AR in the course
Children & adolescents Age range: 7-17 Mean age: 12.4
Inclusion: diagnosis of all year-round AR (mild and moderate severity) with clinically significant sensitization to house allergens. The patients were enrolled while experiencing exacerbation of persistent AR, with a total score for nasal symptoms (TNSS) of 2 points or more Exclusion: seasonal exacerbations caused by associated pollinosis
21-day treatment Ectoine: 2 doses per nostril, 3 times per day INS: as prescribed 2 visits
Children & adolescents Age range: not assessed Mean age: not assessed
Inclusion: children with diagnosis of AR
10-day treatment Ectoine: as prescribed Standard of care: as prescribed
Itchiness, periodic sneezing, coughing, voice changes, night snoring, emotional profiles
No information given
0
Salapatek et al., 2011, Canada [43] (manuscript accepted for publication)
Allergic rhinoconjunctivitis
Placebo
R, C
Total: 46 Ectoine: 46 Placebo: 46
Adults Age range: 18-65 Mean age:
Inclusion: history of seasonal AR, positive skin prick test, , Exclusion: usage of antiallergic medication before study start and throughout the study
14-day treatment per treatment type crossover after 7 days washout Ectoine: 1 spray/nostril 3 times per day Placebo: 1 spray/nostril 3 times per day 5 visits
Primary: TNSS (including sneezing, itchy nose, runny nose and nasal congestion) and TOSS (including watery eye, itchy eye, red eye) Secondary: TNNSS (including watery eye, itchy eye, red eye, and itchy ear/palate), and acoustic rhinometry measurements
6 AEs reported during ectoine treatment. During placebo treatment, 5 AEs were reported. No SAEs occurred
Inclusion: patients aged 18-70, proven allergy in prick test, acute symptoms in nose and eyes Exclusion: pregnant and nursing women, drug addicts, patients with intolerance against ingredients of treatments, previous eye or nose surgery
7-day treatment Ectoine: one eye drop per eye and one puff of the nasal spray per nostril four times per day Azelastine: One eye drop, one puff nasal spray, both twice per day 2 visits
8 AEs: 2 cases of burning of eyes and itching of the throat in the ectoine group, and 6 (4 cases of burning of eyes, 1 case of nausea, and 1 case of headache) in the azelastine group
Inclusion: patients aged 18-70, proven allergy in prick test, acute symptoms in the nose and eyes Exclusion: pregnant and nursing women, drug addicts, patients with intolerance against ingredients of treatments, previous eye or nose surgery
14-day treatment crossover after 7 days Ectoine: 5 times per day, cromoglicic acid (20 mg/ml): nasal spray 4 times per day 3 visits
Total: 45 Group persistent allergic rhinitis: 25 Group intermittent allergic rhinitis: 20
Pregnant women Age range: 18-40 Mean age:
Inclusion: pregnancy, proven case of AR at the time of examination, aged 18 to 40 years, presence of 2 or more typical signs of AR, bright-red mucosa in aggravated seasonal allergic rhinitis, cyanotic or gray mucosa in perennial allergic rhinitis, the mucosa spotting (“marbling”) (Voyachek’s symptom) Exclusion: present infectious diseases, history of alcohol or drug abuse, problems that may limit the patient’s ability to follow the protocol requirements, participation in another clinical trial during the three months preceding the screening visit, any other conditions that make it difficult to participate in the study
All patients received 1-2 doses of ectoine 3-4 times a day or for 10 days before contact with allergens
Children & adolescents Age range: not assessed Mean age: not assessed
Inclusion: diagnosis of persistent AR, domestic or epidermal sensitization, exacerbation of the disease at the first visit Exclusion criteria not described
4 weeks of treatment Treatments as prescribed 3 visits
Rhinocytogram status, eosinophil count (laboratory test), result of the anterior rhinoscopy, result of the TNSS
AEs reported during the study were resolved completely by days 8 to 15 of administration
Inclusion: confirmed mono allergy to tree pollen, mild-moderate IAR, two courses of ASIT Exclusion: severe IAR, noncompliance, nose surgery, use of antiallergic drugs
Max. 37-day treatment Ectoine: 1-2 sprays 3-4 times daily (or as necessary) 2 visits
Nasal obstruction, sneezing, nasal itching, skin test, laboratory test with specific serum IgE antibodies, cytological analysis of nasal secretions, otorhinolaryngological examination
Inclusion: tree pollen sensitization confirmed positive test for IgE antibodies Exclusion: severe IAR, noncompliance, nose surgery, use of antiallergic drug
7-day treatment Ectoine: 1-2 sprays 3-4 times daily (or as necessary) 2 visits
Nasal obstruction, sneezing, nasal itching, skin test, laboratory test with specific serum IgE antibodies, cytological analysis of nasal secretions, otorhinolaryngological examination
No AE reported
0
Study design: randomized (R); controlled (C); open-label (OL); noninterventional (NI).
