Publications by authors named "Tim Shea"

Article Synopsis
  • A new electronic patient reported outcome diary was created to measure chest-related symptoms in kids and adolescents during upper respiratory infections, and this research aimed to validate its effectiveness across different age groups.
  • The study included 195 participants of varying ages (6-8, 9-11, 12-17, and 18+ years) who filled out the diary twice daily for 10 days while sick, analyzing the data for reliability and validity.
  • Results showed that the diary had high completion quality, consistent symptom scores across age groups, and strong reliability and validity, indicating it effectively captures the chest-related symptoms experienced by patients.
View Article and Find Full Text PDF
Article Synopsis
  • The article discusses qualitative interviews with children (6-11 years), adolescents (12-17 years), and adults with colds, as well as their parents, to enhance and validate patient-reported outcome (PRO) measures regarding chest congestion for pediatric clinical trials.
  • The study involved two rounds of interviews, including concept elicitation to gather experiences of chest congestion and cognitive debriefing to assess the understanding of draft PRO items, which participants tested twice daily on a handheld device.
  • Ultimately, the findings revealed eight symptoms reported by children, leading to improvements in the PRO items, with the most effective metrics selected for future use.
View Article and Find Full Text PDF

Objectives: To determine the efficacy of flurbiprofen 8.75 mg lozenges for patients with laboratory-confirmed streptococcal pharyngitis both before and concomitant with antibiotics.

Methods: This post hoc analysis comprised adult participants from 2 earlier randomized, double-blind, placebo-controlled studies evaluating the analgesic efficacy of flurbiprofen 8.

View Article and Find Full Text PDF

Triprolidine, a first-generation antihistamine for allergic rhinitis, has a shorter half-life and fewer persistent effects relative to other antihistamines and may be useful in the treatment of temporary sleep disturbance. Patients aged ≥18 years old were randomized 1:1:1 to receive either triprolidine 2.5 mg (n = 65), triprolidine 5 mg (n = 66), or placebo (n = 67) on 3 consecutive nights.

View Article and Find Full Text PDF
Article Synopsis
  • * Using a specialized lab model, researchers measured the flurbiprofen levels in different tissue layers over a 60-minute period and found both formulations were quickly detectable in the tissues.
  • * Results indicated that flurbiprofen spray penetrated slightly differently than the lozenge, with a significant portion reaching deeper layers of the tissue, suggesting effective localized action for treating sore throats.
View Article and Find Full Text PDF

Antihistamines have been in clinical use for more than 70 years to treat allergic and nonallergic symptoms including relief from cold and flu symptoms. Despite their widespread use, pharmacokinetic (PK) data are sparse for older, first-generation antihistamines. This phase 1 single-center open-label, randomized, single-dose, 3-way crossover trial evaluated the PK profiles of 2 doses of film-coated triprolidine caplets (2.

View Article and Find Full Text PDF
Article Synopsis
  • A study was conducted to assess the safety of an extended-release formulation of guaifenesin, used for treating productive cough with mucus in Indian patients, since safety data was previously limited.
  • 552 adults suffering from acute upper respiratory tract infections were monitored after taking 1200 mg of the medication every 12 hours for a week, with adverse events (AEs) documented.
  • Results showed 29 mild AEs in 28 patients, mostly gastrointestinal and nervous system-related, with no serious AEs or deaths, and many patients reported satisfaction with their treatment outcomes.
View Article and Find Full Text PDF

The aim of this investigation was to develop receiver and extraction fluids, and subsequently validate an analytical method to quantify the permeation and penetration of flurbiprofen into human pharynx tissue using a Franz diffusion cell. The solubility and stability of flurbiprofen in a suitable receiver fluid, and a suitable extraction method and fluid to recover and quantitate flurbiprofen from human pharynx tissue, were investigated using high-performance liquid chromatography (HPLC). The potential interference of human pharynx tissue in the receiver fluid was also investigated.

View Article and Find Full Text PDF

Background: The double stopwatch (DSW) method for determining the onset of analgesic activity has been implemented extensively by investigators studying orally administered drugs.

Objective: The aim of this randomised, placebo-controlled trial was to use the DSW method to determine the time to onset of analgesia of a single dose of a topically administered non-steroidal anti-inflammatory drug, flurbiprofen 8.75 mg lozenge.

View Article and Find Full Text PDF

Aim: Patients with pharyngitis often describe various sensory, affective and evaluative pain qualities. Using an 11-word/phrase index, the Qualities of Sore Throat Index (QuaSTI), we characterized throat symptoms and evaluated changes in a randomized controlled trial (NCT01986361).

Materials & Methods: Patients received a single flurbiprofen 8.

View Article and Find Full Text PDF

Background: Despite the well-known fact that antibiotics (AB) are not effective against viruses, many patients ask for - and all too often doctors provide - AB for treating URTIs. Over-prescribing of AB is one of the key causes for the development of bacterial resistance, which the U.S.

View Article and Find Full Text PDF