Efficacy of a paracetamol–pseudoephedrine combination for treatment of nasal congestion and pain-related symptoms in upper respiratory tract infection
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Objective: This study compared the efficacy of 1000 mg of paracetamol combined with 60 mg of pseudoephedrine, with that of either paracetamol or pseudoephedrine alone and placebo for the treatment of symptomatic URTI.Research design and methods: A double‐blind, parallel group study was performed on 305 patients with URTI (nasal airflow resistance [NAR] of > 0.25 Pa cm3 s and a global pain score of at least moderate intensity). NAR and pain relief/intensity scores were measured over 4 h after initial dose. Patients then dosed up to three times daily for 3 days and recorded nasal congestion and pain intensity scores.Main outcome measures: Nasal airflow conductance (NAC) and pain relief after the initial dose were primary objectives. NAC was calculated from NAR. Pain relief was measured on a 5‐point verbal rating scale (VRS) and pain intensity and nasal congestion on a 4‐point VRS. Data were analysed using analysis of covariance. Safety was assessed by adverse events.Results: A single dose of the combination was superior to paracetamol and placebo for NAC ( p = 0.0001) and was superior to pseudoephedrine and placebo for pain relief ( p ≤ 0.048). Multiple doses of the combination were also superior to paracetamol and placebo for decongestion ( p ≤ 0.021) and were superior to pseudoephedrine and placebo for pain reduction ( p ≤ 0.0057). All treatments were well tolerated.Conclusions: The combination treatment provided a greater decongestant effect than either paracetamol or placebo and better pain relief than either pseudoephedrine or placebo. The additive effect of the combination was apparent for both single and multiple doses.Keywords:
Nasal congestion
Pseudoephedrine
Respiratory tract
A post-marketing, general practitioner surveillance programme involving 12,679 patients with upper respiratory congestion was carried out to assess how well tolerated was symptomatic treatment with a combination oral preparation containing azatadine maleate (1 mg) and pseudoephedrine sulphate (120 mg) given twice daily for up to 15 days. The improvement which patients experienced in the symptoms of sneezing, running nose, stuffy nose, watery eyes and itchy eyes was also evaluated. Analysis of the results showed that 97% of the patients experienced some relief. The incidence of drug-related side-effects was 4% but only 253 (2%) patients discontinued treatment for this reason. The side-effect most frequently reported was drowsiness and this was considered to be probably or possibly due to treatment in 332 (3%) of the patients.
Nasal congestion
Pseudoephedrine
Decongestant
Nasal decongestant
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The majority of patients with seasonal allergic rhinitis (SAR) suffer from nasal congestion. Desloratadine, a nonsedating H1-receptor antagonist, has given decongestant relief to patients with mild-to-moderate nasal congestion associated with SAR. The following study was undertaken to show that a once-daily formulation of desloratadine/pseudoephedrine would provide greater decongestant relief to patients experiencing moderate-to-severe nasal congestion compared with component monotherapy. A total of 1018 patients were assigned randomly to receive desloratadine/pseudoephedrine (5 mg/240 mg), desloratdine (5 mg), or pseudoephedrine (240 mg) daily for 15 days. Over the 15-day study period, patients receiving desloratadine/pseudoephedrine combination tablets had a significant reduction in mean A.M./P.M. reflective nasal congestion scores compared with patients receiving desloratadine or pseudoephedrine (p < 0.01); this reduction reached significance by day 2. Desloratadine/pseudoephedrine combination tablets also produced a greater reduction in A.M. instantaneous nasal congestion scores compared with component monotherapy (p < 0.01), indicating not only superior efficacy but also a full 24-hour effect. Desloratadine monotherapy reduced all mean nasal congestion scores to a similar degree as compared with pseudoephedrine monotherapy (p = NS). No unusual or unexpected adverse events were reported in any group. It was concluded that desloratadine/pseudoephedrine offers additional benefit to patients with moderate-to-severe SAR-associated nasal congestion compared with pseudoephedrine therapy alone.
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Pseudoephedrine
Decongestant
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Nonsedating antihistamines are a first-line therapy in the management of allergic rhinitis. They relieve the majority of the histamine-mediated symptoms of the condition, including rhinorrhea, sneezing, and pruritus. The nonsedating antihistamine desloratadine is effective in alleviating the symptoms of both seasonal and perennial allergic rhinitis. It may also have some decongestant properties, and thus help to alleviate nasal congestion. Administering desloratadine in combination with the decongestant pseudoephedrine may offer allergic rhinitis patients with moderate-to-severe nasal congestion the benefits of desloratadine's effectiveness for alleviating histamine-mediated symptoms plus pseudoephedrine's relief from nasal congestion. This drug profile reviews a combination therapy containing desloratadine and pseudoephedrine, approved in the USA for the relief of the symptoms of seasonal allergic rhinitis, including nasal congestion.
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Decongestant
Nasal congestion
Pseudoephedrine
Nasal decongestant
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Abstract This multicenter, double‐blind, placebo‐controlled, randomized study was designed to evaluate the efficacy and safety of pseudoephedrine hydrochloride 30‐mg tablets in children aged 6 to 11 years for the temporary relief of nasal congestion due to the common cold. The primary efficacy end point was the weighted sum of the change from baseline in instantaneous nasal congestion severity score over the period from 1 to 8 hours following the first dose of study drug on day 1. Safety assessments included adverse events, sleepiness ratings, and vital signs. Pseudoephedrine was superior to placebo in reducing instantaneous nasal congestion severity in pediatric children over the first 8 hours after dosing on day 1 (least squares mean difference between treatment groups was 1.2; P = .029). Overall, secondary end points associated with nasal congestion were supportive on day 1, whereas secondary end points on day 2 were only numerically favorable. Somnolence was reported in a greater percentage of children on pseudoephedrine compared to placebo (71.9% vs 63.9%), while similar percentages of children in the same respective groups reported insomnia (34.4% and 38.9%) and nervousness (20.0% and 23.6%).Pseudoephedrine provides temporary relief of nasal congestion associated with the common cold in children 6 to <12 years of age at the current over‐the‐counter monograph dose. Multiple dosing of pseudoephedrine for up to 7 days, when given as needed for symptom relief, was generally safe in this population of children with the common cold.
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Nasal congestion
Somnolence
Nasal decongestant
Common cold
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For most patients with allergic rhinitis, nasal congestion is the most bothersome symptom. Oral pseudoephedrine is effective for nasal congestion, but federal laws have limited its availability because of its use in methamphetamine production. Phenylephrine, another over-the-counter oral decongestant, is more readily available, but data on its efficacy are limited. In this open-label trial, U.S. investigators randomized 539 adults with allergic rhinitis to …
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Nasal congestion
Decongestant
Nasal decongestant
Phenylephrine
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To explore the relationship between DPP-4 inhibitors and upper respiratory tract infection.In order to provide reference for clinical treatment, the clinical research of DPP-4 inhibitors in recent years on the upper respiratory tract infections were retrieved and analyzed.Adverse drug reaction analysis of DPP-4 inhibitors prompted an increase in the risk of upper respiratory tract infections, but the subsequent clinical studies did not confirm this view.There were two studies demonstrated saxagliptin had seen a slight increase in the incidence of upper respiratory tract infection slightly when combined with metformin, but other DPP-4 inhibitors have not been proven to increase the infection of the upper respiratory tract.Saxagliptinwhen combined with metforminmay may increase the upper respiratory tract infection, but further confirmation is required.Other DPP-4 inhibitors are not found to increase respiratory tract infections.
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Type 2 diabetes; Antidiabetic drugs; DPP-4 inhibitors; Upper respiratory tract infection
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Respiratory infection
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A method has been developed to equalize as many of the variables as possible in a clinical trial to assess the response to medication in allergic rhinitis. This method was used to study the effectiveness of azatadine maleate and pseudoephedrine sulfate alone and in combination. Azatadine effectively relieved symptoms of hay fever but did not reduce nasal congestion to a significant degree. Pseudoephedrine relieved nasal congestion but did not reduce symptoms. The combination of azatadine and pseudoephedrine relieved both symptoms and congestion.
Decongestant
Pseudoephedrine
Nasal congestion
Nasal decongestant
Hay fever
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■ Abstract Background: Antihistamines are fi rst-line therapy for the treatment of seasonal allergic rhinitis (AR); however, an oral decongestant is often added to improve control of nasal congestion. Objective: To examine whether a tablet combining the nonsedating antihistamine desloratadine and the decongestant pseudoephedrine was more effective than either drug administered alone in reducing the symptoms of seasonal AR, including nasal congestion. Patients and Methods: In this multicenter, double-blind study, participants (N = 598) with symptomatic seasonal AR were administered either a combination tablet of desloratadine 2.5 mg/pseudoephedrine 120 mg (DL/PSE) bid, a desloratadine 5.0 mg qd and a placebo tablet, or pseudoephedrine 120 mg bid. Participants assessed their symptom severity twice daily over the 2-week treatment period. Results: The primary variable to assess the effects of the antihistamine component‐mean change from baseline in average AM/PM refl ective total symptom score (TSS), excluding nasal congestion‐was signifi cantly greater (‐6.54) for DL/PSE than for desloratadine (‐5.09) or pseudoephedrine (‐5.07) monotherapy (P < .001 for both). The primary variable to assess the effects of the decongestant component‐mean change from baseline in average AM/PM refl ective nasal congestion score‐was also signifi cantly greater (‐0.93) for DL/PSE than for desloratadine (‐0.66) or pseudoephedrine (‐0.75) (P<.001 vs desloratadine; P = .006 vs pseudoephedrine). Conclusion: This study demonstrated that DL/PSE therapy was more effective in reducing symptoms of seasonal AR, including nasal congestion, than the individual components when administered alone, thus supporting use of this combination in participants with symptomatic seasonal AR and prominent nasal congestion.
Desloratadine
Decongestant
Pseudoephedrine
Nasal congestion
Nasal decongestant
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Pseudoephedrine
Nasal congestion
Somnolence
Decongestant
Hay fever
Nasal spray
Nasal decongestant
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Pseudoephedrine (60 mg) is widely used as an oral decongestant taken in tablet or syrup formulations every 4-6 hours for the treatment of nasal congestion associated with common cold and allergy. However, there are relatively few studies in the literature that have used objective measures of nasal airway resistance (NAR) to assess the efficacy of pseudoephedrine, and most studies use only a single dose of medication. The present study has the aims of studying the safety and efficacy of a new pseudoephedrine formulation after single and multiple doses in patients with URTI.The study was a double-blind, randomized, parallel-group, placebo-controlled trial conducted over three study days at a single center. Patients suffering from nasal congestion associated with common cold were recruited and total NAR was measured by the technique of posterior rhinomanometry. NAR and subjective scores of nasal congestion were measured at baseline and after dosing with study medication, every hour over a four-hour period on day 1 after a single dose, and on day 3 after multiple doses of medication. Subjective scores of congestion/stuffiness were also made as a summary score at the end of each day of treatment.Two hundred and thirty-eight patients with nasal congestion associated with acute upper respiratory tract infection (URTI), mean age 20 years, were recruited to the study and received treatment. After a single dose on day 1 the pseudoephedrine group had a statistically significant lower area under the NAR curve than placebo (p = 0.006) for the primary efficacy variable area under the NAR curve from 0-3 hours (NAR AUC 0-3h), and similarly for the secondary efficacy variable NAR AUC 0-4h (p = 0.001). On day three after multiple doses, the pseudoephedrine group had a statistically significant lower NAR AUC 0-3h and AUC 0-4h than placebo (p < 0.001), On day 1, the pseudoephedrine group had significantly lower subjective scores for congestion than placebo visual analog scale (VAS) AUC 0-3h (p = 0.029) and similarly for VAS AUC 0-4h (p = 0.021). On day 3, the differences in subjective scores were not significantly different. The mean decrease from baseline of the summary score for congestion/stuffiness over the duration of the study was greater in the pseudoephedrine group compared to the placebo group (p = 0.016). On average, heart rate was between two and four beats per minute greater in the pseudoephedrine group compared to placebo. Five adverse events were reported in both treatment groups and these were deemed to be unrelated to treatment.The results demonstrate that pseudoephedrine is a safe and effective treatment for nasal congestion associated with URTI. The results from the laboratory study on day 1 demonstrate by both objective and subjective measures of nasal congestion that a single dose of 60 mg pseudoephedrine is superior to placebo treatment. Support for the decongestant efficacy of multiple doses of pseudoephedrine is provided by objective measures on day 3 and subjective measures made over three days, but not by the VAS scores on day 3.
Nasal congestion
Pseudoephedrine
Nasal decongestant
Decongestant
Common cold
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