Effects of terfenadine and pseudoephedrine, alone and in combination in a nasal provocation test and in perennial rhinitis

The effects of terfenadine and pseudoephedrine, alone and in combination, have been assessed in a nasal provocation test and in perennial rhinitis. In a double-blind, placebo-controlled cross-over nasal provocation test, twelve men allergic to grass pollen were treated with two daily doses of placebo, terfenadine 60 mg, pseudoephedrine 120 mg, or the combination of the two, for 2 days preceding each test. The allergic reaction threshold, based on rhinorrhoea, sneezing and nasal inspiratory peak flow rate, was raised significantly both by terfenadine and pseudoephedrine, and their effects appeared additive (repeated measures analysis of variance). In a double-blind, randomized clinical study of perennial rhinitis two parallel groups, the efficacy and tolerability of terfenadine and terfenadine-pseudoephedrine were compared in 50 patients. Symptoms and signs in both groups were improved after 14 days of treatment. Differences between groups showed a trend in favour of terfenadine-pseudoephedrine, for swelling of the nasal mucosa (rhinoscopy) they were statistically significant. Both medications were well tolerated overall, although adverse events and reactions were more frequent in the terfenadine-pseudoephedrine group. In conclusion, terfenadine-pseudoephedrine and its constituents taken alone were effective. The combination performed better, but adverse events were somewhat more frequent with the combination than with terfenadine alone

Double-blind comparison of astemizole, terfenadine and placebo in hay fever with special regard to onset of action

In this double-blind study forty-seven patients with hay fever were treated for 8 days with either terfenadine 60 mg twice a day, astemizole 10 mg once a day or placebo. On the second day of treatment terfenadine was statistically significantly superior to astemizole and placebo according to the ratings of symptomatology, efficacy and individual symptoms. The median onset of symptom alleviation was 3 hours for terfenadine and 2 days for astemizole. On the eighth day both astemizole and terfenadine were statistically significantly more efficacious than placebo, but no significant differences were found between the two drugs. Both drugs were well tolerated

Multi-Centre Double-Blind Comparison of Terfenadine Once Daily versus Twice Daily in Patients with Hay Fever

This double-blind, randomized multi-centre study was designed to compare efficacy and tolerability of 120 mg terfenadine taken once daily (in the morning) with the established regimen of 60 mg terfenadine taken twice daily in the treatment of seasonal rhinitis. Two comparable groups, a total of 191 hay fever patients, were treated for 1 week. Symptom severity was assessed by the investigators before and at the end of the treatment (visual analogue scale), and daily by the patient (four-point rating scale). All symptoms improved to a similar degree in both groups. Differences between the two groups were not statistically significant, except for nasal symptoms in three cases as assessed by the visual analogue scale in one centre (better relief in the group given 120 mg terfenadine once daily). Tolerability was good and similar in both groups. The data presented show that in the treatment of hay fever 120 mg terfenadine given once daily is an effective, convenient and well tolerated alternative to the regimen of 60 mg terfenadine given twice daily. </jats:p

Randomized, double blind, placebo-controlled, safety and efficacy study of dutogliptin in combination with filgrastim in early recovery post-MI: rationale, design and first interim analysis

Abstract Background Regenerative therapies offer new approaches to improve cardiac function after acute ST-elevation myocardial infarction (STEMI). Mobilization of stem cells and homing within the infarcted area have been identified as the key mechanisms for successful treatment. Application of granulocyte-colony stimulating factor (G-CSF) is the least invasive way to mobilize stem cells while DDP4-inhibitor facilitates homing via stromal cell-derived factor 1 alpha (SDF-1α). Dutogliptin, a novel DPP4 inhibitor, combined with stem cell mobilization using G-CSF significantly improved survival and reduced infarct size in a murine model. Purpose We initiated a phase II, multicenter, randomized, placebo-controlled efficacy and safety study (N=140) analyzing the effect of combined application of G-CSF and dutogliptin, a small molecule DPP-IV-inhibitor for subcutaneous use after acute myocardial infarction. Methods The primary objective of the study is to evaluate the safety and tolerability of dutogliptin (14 days) in combination with filgrastim (5 days) in patients with STEMI (EF &amp;lt;45%) following percutaneous coronary intervention (PCI). Preliminary efficacy will be analyzed using cardiac magnetic resonance imaging (cMRI) to detect &amp;gt;3.8% improvement in left ventricular ejection fraction (LV-EF). 140 subjects will be randomized to filgrastim plus dutogliptin or matching placebos. Results Baseline characteristics of the first 26 patients randomized (24 treated) in this trial reveal a majority of male patients (70.8%) and a medium age of 58.4 years (37 to 84). During the 2-week active treatment period, 35 adverse events occurred in 13 patients, with 4 rated as serious (hospitalization due to pneumonia N=3, hospitalization due to acute myocardial infarction N=1), and 1 adverse event was rated as severe (fatal pneumonia), 9 moderate, and 25 as mild. 6 adverse events were considered possibly related to the study medication, including cases of increased hepatic enzymes (N=3), nausea (N=1), subcutaneous node/suffusion (N=1) and syncope (N=1). Conclusions Our data demonstrate that the combined application of dutogliptin and G-CSF appears to be safe on the short term and feasible after acute myocardial infarction and may represent a new therapeutic option in future. Funding Acknowledgement Type of funding source: Other. Main funding source(s): This research is funded by the sponsor RECARDIO, Inc., 1 Market Street San Francisco, CA 94150, USA. RECARDIO Inc. is funding the complete study. The Scientific Board of RECARDIO designed the study. Data Collection is at the participating sites. Interpretation of the data by the Scientific Board and Manuscript written by the authors and approved by the Sponsor </jats:sec

Photonic-Eletronic Arbitrary Waveform Generation up to 100 GHz Using Active Phase Stabilization

We demonstrate photonic-electronic ultra-broadband arbitrary waveform generation based on coherent reception of IQ signals and active phase stabilization. We show the viability of our concept by generating OOK and PAM4 data signals at symbol rates up to 200 GBd.</jats:p