Mometasone furoate nasal spray reduces symptoms and improves quality of life in Chinese patients with moderate to severe allergic rhinitis: a multicenter open-label study

2009 ◽  
pp. 1-6
Author(s):  
Luo Zhang ◽  
Geng Xu ◽  
Xiangdong Wang ◽  
Shixi Liu ◽  
Yuan Li ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Mometasone Furoate ◽  
Chinese Patients ◽  
Open Label ◽  
Open Label Study ◽  
Label Study

scholarly journals Functional impairment and disability among patients with migraine: evaluation of galcanezumab in a long-term, open-label study

2020 ◽  
Author(s):  
Janet H. Ford ◽  
Virginia L. Stauffer ◽  
Peter McAllister ◽  
Sreelatha Akkala ◽  
Matthew Sexson ◽  
...  
Keyword(s):  
Quality Of Life ◽  
Treatment Phase ◽  
Phase Iii ◽  
Life Questionnaire ◽  
Open Label ◽  
Open Label Study ◽  
Label Study ◽  
Patient Reported ◽  
Domain Scores

Abstract Purpose Migraine can negatively impact patient functioning and quality of life. Here, we report the effects of galcanezumab (GMB), a humanized monoclonal antibody that binds to calcitonin gene-related peptide, on patient-reported outcome (PRO) measures in migraine. Methods CGAJ was a Phase III, randomized, open-label study (12-month open-label and 4-month post-treatment follow-up) in patients with episodic or chronic migraine. Patients aged 18–65 years with diagnosis of migraine (≥ 4 migraine headache days per month) as defined by International Classification of Headache Disorders (ICHD)-3 beta guidelines were included in the study. Patients were randomized 1:1 with subcutaneous GMB 120 mg (with a loading dose of 240 mg) or GMB 240 mg given once monthly for 12 months. Changes from baseline in PRO measures such as Migraine-Specific Quality of Life Questionnaire v2.1 (MSQ) and Migraine Disability Assessment (MIDAS) were assessed. Results A total of 135 patients were randomized to each galcanezumab dose group. Mean (SD) baseline MSQ total scores were 53.85 (20.34) [GMB 120 mg] and 53.69 (18.79) [GMB 240 mg]. For MIDAS, mean (SD) total scores were 45.77 (42.06) [GMB 120 mg] and 53.96 (61.24) [GMB 240 mg]. Within-group mean improvement from baseline on MSQ and MIDAS total scores and all individual item/domain scores were statistically significant for both GMB dose groups, at all-time points during the treatment phase (p < 0.001). For MSQ domain scores, greatest improvement was observed in the Role function-restrictive (RF-R) domain (overall least squares (LS) mean change ± SE: 31.55 ± 1.20 [GMB 120 mg] and 33.40 ± 1.16 [GMB 240 mg]). For MIDAS, the overall LS mean change ± SE from baseline across the entire 12-month treatment phase in total scores were: −33.58 ± 2.11 (GMB 120 mg) and −32.67 ± 2.04 (GMB 240 mg). Conclusion Galcanezumab was associated with statistically significant changes from baseline in the PRO measures across the entire 12-month treatment period. These results indicate improved health-related quality of life and decreased disability among patients treated with galcanezumab.

scholarly journals Noninterventional Open-Label Trial Investigating the Efficacy and Safety of Ectoine Containing Nasal Spray in Comparison with Beclomethasone Nasal Spray in Patients with Allergic Rhinitis

2014 ◽  
Vol 2014 ◽  
pp. 1-12 ◽  
Author(s):  
Uwe Sonnemann ◽  
Marcus Möller ◽  
Andreas Bilstein
Keyword(s):  
Quality Of Life ◽  
Allergic Rhinitis ◽  
Nasal Spray ◽  
Efficacy And Safety ◽  
Open Label ◽  
Equivalence Test ◽  
Nasal Symptoms ◽  
Open Label Trial ◽  
Design And Methods

Objectives. The current study aimed to compare the efficacy and safety of a classical anti-inflammatory beclomethasone nasal spray in comparison to a physic-chemical stabilizing ectoine containing nasal spray in the treatment of allergic rhinitis. Design and Methods. This was a noninterventional, open-label, observational trial investigating the effects of beclomethasone or ectoine nasal spray on nasal symptoms and quality of life. Over a period of 14 days, patients were asked to daily document their symptoms. Efficacy and tolerability were assessed by both physicians and patients. Results. Both treatments resulted in a significant decrease of TNSS values. An equivalence test could not confirm the noninferiority of ectoine treatment in comparison with beclomethasone treatment. Although clear symptom reduction was achieved with the ectoine products, the efficacy judgment showed possible advantages for the beclomethasone group. Importantly, tolerability results were comparably good in both groups, and a very low number of adverse events supported this observation. Both treatments resulted in a clear improvement in the quality of life as assessed by a questionnaire answered at the beginning and at the end of the trial. Conclusion. Taken together, it was shown that allergic rhinitis can be safely and successfully treated with beclomethasone and also efficacy and safety were shown for ectoine nasal spray.

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