Futura study: evaluation of efficacy and safety of rupatadine fumarate in the treatment of persistent allergic rhinitis

Objective. To compare the efficacy and safety of pterygopalatine fossa puncture using one acupuncture needle inserted through the temporal fossa (intervention) and Chinese verum acupuncture (VA) in patients with moderate-to-severe persistent allergic rhinitis. Methods. The patients were randomized to an intervention group receiving pterygopalatine fossa puncture with one acupuncture needle for 4 weeks (once or twice weekly, 4–8 sessions in total, with a second course performed if required) or to a control group receiving individualized VA for 4 weeks (twice weekly, eight sessions in total). Patients were followed up 4 weeks later. Results. Ninety-six participants were assigned to intervention (n = 48) or VA (n = 48) groups. After treatment, differences in the total nasal symptom score (2004 Chinese version), total nonnasal symptom score, Rhinoconjunctivitis Quality of Life Questionnaire score, and symptomatic days were not significant between the groups (P>0.05 in all cases). Compared with the VA, the time to onset of effect in the intervention group was shorter and the duration of effectiveness was longer. The mean clinical waiting time was significantly shorter in the intervention group than in the control group (6.640 ± 3.035 min and 31.19 ± 10.216 min, respectively). The total number of sessions in the VA group was 384; 7 episodes of subcutaneous bleeding occurred but did not require treatment. The total number of sessions in the intervention group was 185. Two cases of subcutaneous bleeding (one of local hematoma during the intervention and the other one of bruising in the palpebra inferior on the day after intervention) resolved upon withdrawal from the study. Conclusions. Pterygopalatine fossa puncture using one acupuncture needle resulted in a shorter time to onset of effect, a longer duration of effectiveness, and less clinical waiting time when compared with VA. Though the significant differences for TNSS and TNNSS were shown within intervention and VA groups, there were no differences between the two groups. Although the rate of subcutaneous bleeding was low, these adverse events may influence patient compliance. This trial is registered with ISRCTN21980724.

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A Randomized, Open-label, Parallel-group Clinical Study to Evaluate the Efficacy and Safety of Omalizumab in the Treatment of Persistent Moderate and Severe Allergic Asthma and Persistent Allergic Rhinitis in Pediatric Patients 6 to 17 years of age

Journal of Allergy and Clinical Immunology ◽

10.1016/j.jaci.2018.12.288 ◽

2019 ◽

Vol 143 (2) ◽

pp. AB94

Author(s):

Socorro Orozco Martinez ◽

Alvaro Pedroza-Meléndez ◽

Vania Trejo-Uribe ◽

Sandra Bautista-García ◽

Alberto Contreras-Verduzco ◽

...

Keyword(s):

Allergic Rhinitis ◽

Clinical Study ◽

Allergic Asthma ◽

Pediatric Patients ◽

Efficacy And Safety ◽

Open Label ◽

Persistent Allergic Rhinitis ◽

Parallel Group ◽

Severe Allergic Asthma

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Efficacy and Safety of Sanfu Herbal Patch at Acupoints for Persistent Allergic Rhinitis: Study Protocol for a Randomized Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2015/214846 ◽

2015 ◽

Vol 2015 ◽

pp. 1-10 ◽

Cited By ~ 3

Author(s):

Xiankun Chen ◽

Chuanjian Lu ◽

Cecilia Stålsby-Lundborg ◽

Yunying Li ◽

Xiaoyan Li ◽

...

Keyword(s):

Allergic Rhinitis ◽

Controlled Trial ◽

Treatment Session ◽

Waiting List ◽

Life Questionnaire ◽

Efficacy And Safety ◽

Persistent Allergic Rhinitis ◽

One Year ◽

Group B

Background. The Sanfu herbal patch (SHP) has been widely used to treat allergic rhinitis (AR) in China. SHP has been reported to be effective for managing the symptoms of AR, but the evidence suffers from methodological limitations. Therefore, we designed a three-armed, randomized, and placebo-controlled trial to evaluate the efficacy and safety of SHP for persistent allergic rhinitis (PAR).Methods. The trial consists of 5 treatment sessions along with a one-year follow-up. This process is then repeated in the second and third years. Eligible participants diagnosed with PAR were randomized at a ratio of 2 : 2 : 1 into one of three groups: (a) SHP group; (b) placebo group; or (c) waiting-list group. The waiting-list group will receive no treatment in the first year but will receive SHP in the following two years. The primary outcome, total nasal symptoms score, is self-assessed at the beginning of each treatment session and during each annual follow-up. Secondary outcomes include the Rhinoconjunctivitis Quality-of-Life Questionnaire, allergic rhinitis attacks, and relief medications. The trial will be stopped if early termination criteria are met during the interim analysis.Ethics. This protocol has been approved by site ethics committee (number B2014-014-01) and is registered with ClinicalTrials.govNCT02192645.

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