Effect of fexofenadine hydrochloride on allergic rhinitis aggravated by air pollutants

In recent decades, seasonal allergic rhinitis (SAR) prevalence has increased and recent studies have shown that air pollutants, such as diesel exhaust particles (DEP), can increase inflammatory and allergic biomarkers. The aim of this study was to investigate the effects of DEP on SAR symptoms induced by ragweed and to evaluate the efficacy and safety of fexofenadine HCl 180 mg versus placebo.This Phase 3, single-centre, sequential, parallel-group, double-blind, randomised study (NCT03664882) was conducted in an environmental exposure unit (EEU) during sequential exposures: Period 1 (ragweed pollen alone), Period 2 (ragweed pollen+DEP), and Period 3 (ragweed pollen+DEP+single-dose fexofenadine HCl 180 mg or placebo). Efficacy and safety were evaluated in Period 3. Primary endpoints were the area-under-the-curve of Total Nasal Symptom Score (TNSS) from baseline to hour 12 (AUC0–12) during Period 1 and Period 2; and the AUC of the TNSS from hour 2 to 12 (AUC2–12) during Period 3.251/257 evaluable subjects were included in the modified intent-to-treat population. Least squares (LS)-mean difference (95% confidence interval [CI]) for TNSS Log AUC0−12 in Period 2 versus Period 1 was 0.13 (0.081, 0.182; p<0.0001). LS-mean difference in TNSS Log AUC2−12 for fexofenadine HCl versus placebo during Period 3 was −0.24 (−0.425, −0.047, p=0.0148). One fexofenadine HCl-related AE was observed.SAR symptoms evoked by ragweed were aggravated by DEP. Fexofenadine HCl 180 mg was effective in relieving pollen-induced, air pollution-aggravated allergic rhinitis symptoms.

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485 Efficacy and Safety of Once- and Twice-Nightly Dosing of Lower-Sodium Oxybate in Adults With Idiopathic Hypersomnia

SLEEP ◽

10.1093/sleep/zsab072.484 ◽

2021 ◽

Vol 44 (Supplement_2) ◽

pp. A191-A192

Author(s):

Isabelle Arnulf ◽

Anne Marie Morse ◽

Patricia Chandler ◽

Rupa Parvataneni ◽

Dan Chen ◽

...

Keyword(s):

Sodium Oxybate ◽

Mean Difference ◽

Controlled Study ◽

Efficacy And Safety ◽

Open Label ◽

Double Blind ◽

Patient Global Impression ◽

Idiopathic Hypersomnia ◽

Secondary Endpoints ◽

Global Impression Of Change

Abstract Introduction Idiopathic hypersomnia (IH) is a rare central hypersomnolence disorder. In a randomized, controlled study of lower-sodium oxybate (LXB; Xywav™) in adults with IH (NCT03533114), significant differences for LXB compared with placebo were observed in Epworth Sleepiness Scale (ESS; primary efficacy endpoint), self-reported Patient Global Impression of Change (PGIc), and IH Severity Scale (IHSS; key secondary endpoints). In this clinical study, investigators were permitted to initiate LXB dosing on a once-nightly or twice-nightly regimen. Methods Eligible participants aged 18–75 years began LXB treatment, administered once or twice nightly during an open-label treatment/titration and optimization period (OLTTOP; 10–14 weeks); dose amount/regimen could be adjusted during this period. Participants next entered a 2-week, open-label, stable-dose period (SDP), then were randomized to placebo or to continue LXB treatment during a 2-week, double-blind, randomized withdrawal period (DBRWP). P values are nominal for this exploratory analysis. Results Of 154 enrolled participants, 40 (26%) initiated LXB treatment on a once-nightly regimen. In the efficacy population (n=115), 27 participants were on a once-nightly regimen during SDP (48.1% of whom initiated treatment once nightly during OLTTOP) and 88 participants were on a twice-nightly regimen during SDP (86.4% of whom initiated treatment twice nightly during OLTTOP). During SDP, median (min, max) LXB total dose was 4.5 (2.5, 6) g/night (once-nightly group) and 7.5 (4.5, 9) g/night (twice-nightly group). ESS scores worsened in participants randomized to placebo vs those continuing LXB in the once-nightly group (n=11 and n=15, respectively; LS mean difference [95% CI]: −4.93 [−7.41, −2.46]; P=0.0004) and twice-nightly group (n=47 and n=41, respectively; LS mean difference [95% CI]: −7.44 [−9.15, −5.72]; P<0.0001). Worsening was also observed in PGIc (once-nightly: 81.8% [placebo] vs 26.7% [LXB]; P=0.0077; twice-nightly: 89.4% [placebo] vs 19.5% [LXB]; P<0.0001) and IHSS score (estimated median difference [95% CI], once-nightly: −9.00 [−16.0, −3.0]; P=0.0028; twice-nightly: −12.00 [−15.0, −8.0]; P<0.0001). Common adverse events included nausea (21.4%), headache (16.2%), anxiety (14.9%), dizziness (11.7%), insomnia (11.7%), and vomiting (10.4%). Conclusion The efficacy and safety of LXB in IH were demonstrated for both once-nightly and twice-nightly regimens. The majority of participants initiated and remained on a twice-nightly regimen. Support (if any) Jazz Pharmaceuticals

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Evidence of the efficacy and safety of house dust mite subcutaneous immunotherapy in elderly allergic rhinitis patients: a randomized, double-blind placebo-controlled trial

Clinical and Translational Allergy ◽

10.1186/s13601-017-0180-9 ◽

2017 ◽

Vol 7 (1) ◽

Cited By ~ 11

Author(s):

Andrzej Bożek ◽

Krzysztof Kołodziejczyk ◽

Renata Kozłowska ◽

Giorgio Walter Canonica

Keyword(s):

Allergic Rhinitis ◽

House Dust ◽

House Dust Mite ◽

Controlled Trial ◽

Subcutaneous Immunotherapy ◽

Efficacy And Safety ◽

Double Blind ◽

Double Blind Placebo ◽

Dust Mite

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Efficacy and Safety of Naftopidil in Patients With Neurogenic Lower Urinary Tract Dysfunction: An 8-Week, Active-Controlled, Stratified-Randomized, Double-Blind, Double-Dummy, Parallel Group, Noninferiority, Multicenter Design

International Neurourology Journal ◽

10.5213/inj.1938198.099 ◽

2020 ◽

Vol 24 (2) ◽

pp. 163-171 ◽

Cited By ~ 1

Author(s):

Hyun Hwan Sung ◽

Myung-Soo Choo ◽

Joon Chul Kim ◽

Jang Hwan Kim ◽

Kyu-Sung Lee

Keyword(s):

Urinary Tract ◽

Lower Urinary Tract ◽

Mean Difference ◽

Lower Urinary Tract Dysfunction ◽

Therapeutic Drug ◽

Efficacy And Safety ◽

Double Blind ◽

Parallel Group ◽

Study Results ◽

Lower Urinary

Purpose: The aim of this study was to evaluate the efficacy and safety of naftopidil compared with tamsulosin in patients with neurogenic lower urinary tract dysfunction (LUTD).Methods: This study was conducted as an 8-week, active-controlled, stratified-randomized, double-blind, double-dummy, parallel group, noninferiority, and multicenter clinical trial. After 2 weeks of screening, eligible subjects were randomly assigned to receive naftopidil (25 mg for 1 week followed by 75 mg for 7 weeks) or tamsulosin (0.2 mg for 8 weeks). Primary endpoint was a change of International Prostatic Symptom Score (IPSS) total score after 8 weeks of treatment.Results: One hundred ninety-four subjects with neurogenic LUTD were included into this trial. There were no differences between the 2 groups in baseline characteristics, including urodynamic study results, subtype of LUTD, pretreatment and concomitant medication, and causes of neurogenic bladder. The medication compliance rate was 94.0% (naftopidil, 93.6%; tamsulosin, 94.4%). There was a statistically significant decrease of IPSS total score at 8 weeks versus baseline in both the naftopidil (-5.64±0.66) and tamsulosin (-6.53±0.65) groups (P<0.0001 each). The mean difference between both groups was 0.89 (upper limit of 95% confidential interval, 2.72), which was lower than the noninferiority limit of 3 points. A subgroup analysis of neurologic lesions and sex found no mean difference of IPSS total score in each group. There was also no difference in safety profiles, including treatment emergent adverse events.Conclusions: Naftopidil was not inferior to tamsulosin as a therapeutic drug for patients with neurogenic LUTD and had a similar safety profile.

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Phase 3, single-center, sequential and parallel-group, double-blind, randomized study evaluating the efficacy and safety of Fexofenadine Hydrochloride 180 mg (Allegra®/Telfast®) versus placebo in subjects suffering from Allergic Rhinitis with symptoms aggravated in presence of pollutants: analysis of individual symptom scores

World Allergy Organization Journal ◽

10.1016/j.waojou.2020.100266 ◽

2020 ◽

Vol 13 (8) ◽

pp. 100266

Author(s):

Anne K. Ellis ◽

Margarita Murrieta-Aguttes ◽

Sandy Furey ◽

Christopher Carlsten

Keyword(s):

Allergic Rhinitis ◽

Randomized Study ◽

Efficacy And Safety ◽

Single Center ◽

Phase 3 ◽

Double Blind ◽

Parallel Group ◽

Symptom Scores

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Clinical Efficacy and Safety of Thai Herbal Formulation-6 in the Treatment of Symptomatic Osteoarthritis of the Knee: A Randomized-Controlled Trial

Evidence-based Complementary and Alternative Medicine ◽

10.1155/2020/8817374 ◽

2020 ◽

Vol 2020 ◽

pp. 1-9

Author(s):

Nut Koonrungsesomboon ◽

Saowaros Nopnithipat ◽

Supanimit Teekachunhatean ◽

Natthakarn Chiranthanut ◽

Chaichan Sangdee ◽

...

Keyword(s):

Knee Pain ◽

Controlled Trial ◽

Common Adverse Event ◽

Mean Difference ◽

Secondary Outcome ◽

Osteoarthritis Of The Knee ◽

Efficacy And Safety ◽

Short Term Treatment ◽

Double Blind ◽

Herbal Formulation

Background. Osteoarthritis of the knee is the most common form of arthritis. Identifying effective and safe herbal formulations that are locally available is viewed as a priority for sustainable development in a region. This study aimed to evaluate the efficacy and safety of Thai herbal formulation-6 (THF-6) in comparison with oral diclofenac in patients with moderate-to-severe osteoarthritis of the knee. Methods. This randomized, double-blind, active-controlled, noninferiority trial randomly assigned patients with osteoarthritis of the knee to receive either THF-6 or diclofenac for four weeks. The primary outcome measure was the change from baseline in knee pain as measured by a 100 mm visual analog scale (VAS). Secondary outcome measures included knee stiffness, a stair climb test, the Knee Injury and Osteoarthritis Outcome Score, and safety parameters. Outcomes were assessed on a biweekly basis. Modified intention-to-treat (MITT) and perprotocol (PP) analyses were applied. Results. A total of 200 patients were enrolled of whom 175 (87.5%) were included in the MITT analysis and 153 (76.5%) in the PP analysis. The mean change in VAS pain did not differ between the two groups, and the upper limit of the two-sided 95% confidence interval (CI) for comparison between the two groups was within the prespecified margin of 10 mm for noninferiority (MITT analysis: mean difference = 0.86, 95% CI = -4.39 to 6.10, p = 0.748 ; PP analysis: mean difference = 1.98, 95% CI = -3.61 to 7.56, p = 0.486 ). Significant improvement was observed in all the efficacy parameters in both groups. Dyspepsia was the most common adverse event: 23 patients in the THF-6 group and 28 in the diclofenac group p = 0.417 . Conclusions. THF-6 offers an alternative to oral diclofenac for the short-term treatment of osteoarthritis of the knee. It was shown to be noninferior to oral diclofenac in relieving knee pain. This trial is registered with ChiCTR-IPR-15007213.

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