A single-dose, open-label, randomized, scintigraphic study to investigate the gastrointestinal behavior of 2 triple-combination cold products (acetaminophen, phenylephrine, and dextromethorphan) in healthy male volunteers.

BACKGROUND: Common cold symptoms may be mitigated by products in caplet, nasal spray, and oral solution formulations, although variations exist in the bioavailability of the active ingredients contained within these products. Rapid gastric emptying (GE) of these active ingredients is important for reducing the delay between drug absorption and onset of cold symptom relief. Hot drink cold remedies are associated with greater comfort and may enhance the bioavailability of active ingredients. The objective of this study was to characterize the gastrointestinal transit of powder (reconstituted in hot water) and caplet formulations of commercially available multisymptom cold medications. METHODS: This was an open-label, single-dose, parallel-group study. Healthy male adults under fasted conditions were randomized 1:1 to receive a single dose of radiolabeled Theraflu Daytime Severe Cold and Cough powder for oral solution or radiolabeled Theraflu ExpressMax Daytime Severe Cold and Cough caplet. External gamma scintigraphy was utilized to monitor GE and intestinal transit of two radiolabeled drug formulations. RESULTS: A total of 28 participants completed the study. The mean ± SE GE onset times were 1.1 ± 0.3 min and 8.5 ± 1.8 min for powder and caplet formulations, respectively. The mean ± SE GE completion times were 121 ± 13 min and 65 ± 13 min, respectively. Despite the similar mean times to GE25%, the powder had later mean GE50% (23 ± 3.0 vs 16 ± 3.2 min, respectively) and GE90% (85 ± 12 vs 36 ± 9 min, respectively) than caplets. Caplets had a shorter overall GE half-life, lower total gastric exposure, and faster transit time through the small intestine versus the powder formulation. No serious safety events were observed. CONCLUSION: The results of this study in healthy male adults suggest that the Theraflu powder formulation had a more rapid GE onset but longer time to GE completion than the caplet formulation. TRIAL REGISTRATION: ClinicalTrials.gov NCT03415243.

Orbital emphysema causing syncope.

Orbital emphysema is an abnormal condition in which air is present within the orbit. We report a rare case of a 19-year-old man who suffered syncopic attacks caused by sniffles following orbital emphysema as a result of trauma. Treating rhinitis is important in patients with orbital emphysema, and patients with cardiac disorders in addition to those with this condition must be warned about the risks of sniffles, sneezing, or nose blowing.

Influence of film digitization on radiological interpretation.

Our objective was to evaluate the influence of changing from analogue to digital imaging on interobserver and intraobserver image interpretation. Three radiologists interpreted 96 three image series of occipitomental radiographs of paranasal sinuses from the films and from the corresponding digitized images from the screen. Images were classified according to degree of abnormality as either normal, with mucosal thickening of less than 5 mm, with mucosal thickening of 5 mm or more, total opacity, air-fluid level or polyp or cyst of maxillary sinuses. In the present study we found that there were more differences between two radiologist's interpretations with a single method than in a single radiologist's interpretations between the methods, although radiologists interpreted fewer pathological findings from the digitized images than from the corresponding films. Our data show that the results of image interpretation are preferentially dependent on the reader rather than on the method of reading.

Paranasal sinus bony structures and sinus functioning during viral colds in subjects with and without a history of recurrent sinusitis.

OBJECTIVES/HYPOTHESIS: The objective was to assess the impact of ostial obstruction and anatomical variations on paranasal sinus functioning during viral colds with computed tomography (CT) in subjects with and without a history of sinusitis. STUDY DESIGN: Cross-sectional study. METHODS: Twenty-three volunteers with a history of recurrent sinusitis and 25 subjects without such history who had an early (symptoms for 2-4 d) natural cold were examined by taking viral specimens and CT scans and recording symptoms. The pathological sinus changes in the CT scans were scored, and several paranasal bony anatomical variations recorded. RESULTS: Viral origin of the cold was identified in 32 (67%) subjects, similarly in the two groups. Ostiomeatal obstruction and anatomical variations were equally frequent in the subjects with and without a sinusitis history (17 of 23 vs. 17 of 25 for ostial obstruction and 17 of 23 vs. 20 of 25 for at least one variation, respectively). However, in the case of ostiomeatal obstruction the combined CT score of ethmoidal and maxillary sinuses was significantly higher in the subjects with a sinusitis history than in those without (mean +/- SD, 3.0 +/- 0.9 vs. 2.3 +/- 1.2 [P =.05, t test]). In the sinusitis-prone subjects, several variations were associated significantly with various pathological sinus CT changes (septal deviation, horizontally situated processus uncinatus, large concha bullosa, and laterally concave concha media), whereas in the control subjects, only the presence of Haller cells was related to sphenoidal sinus disease. CONCLUSION: Ostiomeatal complex obstruction and bony anatomical variations seem to have a greater impact on the functioning of paranasal sinuses during viral colds in sinusitis-prone subjects than in subjects without a sinusitis history. These differences may be associated with the increased risk of bacterial sinusitis.

Pulmonary imaging and function in the common cold.

The common cold is generally considered to be an upper respiratory tract infection. We studied the lower respiratory tract in 76 otherwise healthy young adults with the common cold. Viral infection was diagnosed in 56 (74%) of the 76 subjects. Rhinovirus was detected in 42 (55%) subjects. Chest radiography (CR) and high-resolution computerized tomography (HRCT) were carried out in 40 subjects on day 7, and pulmonary function testing with bronchodilator challenge was carried out in 36 patients on days 7 and 21 of the study. Clinical examinations were carried out on days 1, 7 and 21. The subjects recorded their symptoms on a diary card for 20 d. The mean duration of cough was 8.4 (SD 6.5) d and that of sputum production 5.9 (SD 6.4) d. No abnormal findings were detected in the lungs on auscultation. CR and HRCT showed no pulmonary changes associated with the common cold. No clinically remarkable increases were seen in peak expiratory flow, forced expiration volume in 1 s or forced vital capacity after bronchodilator challenge on either days 7 or 21. All patients made a clinical recovery without antimicrobial therapy within 21 d. We conclude that the common cold in young otherwise healthy adults is an upper respiratory tract infection and that clinically important abnormalities in the lower respiratory tract are rare.

The common cold in patients with a history of recurrent sinusitis: increased symptoms and radiologic sinusitislike findings.

BACKGROUND: We evaluated whether the symptoms and signs and radiologic findings during a common cold are similar in patients who have and have not suffered from recurrent sinusitis. METHODS: We recruited 2 series of volunteer cases from February 1, 1996, to December 31, 1996. Twenty-three adults who claimed to have suffered from recurrent sinusitis and 25 who had never had sinusitis were examined during the period of a self-diagnosed cold of 48 to 96 hours' duration and again after 21 days. Symptom scores were recorded, nasoendoscopy and computed tomography scans were performed, and viral and bacterial specimens were taken. RESULTS: The patients with a history of sinusitis had significantly higher symptom scores than the control patients (P=.04) and had radiologic sinusitislike changes more often (65% [15] vs 36% [9]; difference 29% [95% confidence interval, 2%-56%]; P=.04). The viral etiology of the common cold (verified in 67% of the episodes) was similar in both groups. Pathogenic bacteria were isolated from the middle meatus in 24% (6) of the control patients and only 9% (2) of the sinusitis-prone patients (P=.15). On the basis of the symptomatology, radiologic findings, and bacterial cultures only 2 patients in the sinusitis-prone group should have been treated with antimicrobials. CONCLUSIONS: Some patients are susceptible to both sinusitislike symptoms and radiologic findings during viral common colds. This may cause them to consult their physicians earlier and more often during viral colds, which may result in unnecessary antibiotic treatments. Nasopharyngeal bacteriological cultures may prove to be useful in ruling out bacterial sinusitis.

Computed tomographic study of the common cold.

BACKGROUND: Colds are common, but the abnormalities they produce in the nasal passages and sinus cavities have not been well defined. METHODS: We studied healthy adult volunteers with self-diagnosed colds of 48 to 96 hours' duration and obtained the following data: information on symptoms, computed tomographic (CT) studies of the nasal passages and sinuses, mucosal-transport times, measures of nasal-airway resistance, and viral-culture studies. Thirty-one subjects (mean age, 24 years) had complete evaluations, including CT scans, which were read without knowledge of the clinical data. An additional 79 subjects underwent the same evaluations, except the CT scans. RESULTS: Of the 31 subjects with CT scans, 24 (77 percent) had occlusion of the ethmoid infundibulum; 27 (87 percent) had abnormalities of one or both maxillary-sinus cavities; 20 (65 percent) had abnormalities of the ethmoid sinuses; 10 (32 percent) had abnormalities of the frontal sinuses; and 12 (39 percent) had abnormalities of the sphenoid sinuses. Infraorbital air cells were present in 14 subjects (45 percent), and pneumatization of the middle turbinate (concha bullosa) was noted in 11 subjects (35 percent). Also common were engorged turbinates (in 7 subjects) and thickening of the walls of the nasal passages (in 13). After two weeks, the CT studies were repeated in 14 subjects, none of whom received antibiotics. In 11 of these subjects (79 percent) the abnormalities of the infundibula and sinuses had cleared or markedly improved. Nasal-airway resistance was abnormal in 29 (94 percent) and mucosal transport in 19 (61 percent) of the 31 subjects who had CT scans. Rhinovirus was detected in nasal secretions from 24 (27 percent) of 90 subjects. CONCLUSIONS: The common cold is associated with frequent and variable anatomical involvement of the upper airways, including occlusion and abnormalities in the sinus cavities.