Jorge Garcia

Publications (6)12.78 Total impact

• Article: Development of questionnaires to measure patient preferences for intranasal corticosteroids in patients with allergic rhinitis.

  Eli O Meltzer, James Hadley, Michael Blaiss, Michael Benninger, Miriam Kimel, Leah Kleinman, Leon Dupclay, Jorge Garcia, Michael Leahy, George Georges
  [show abstract] [hide abstract]
  ABSTRACT: To develop a questionnaire to evaluate preferences for attributes of intranasal corticosteroids (INSs) in clinical trials with allergic rhinitis (AR) patients. Established questionnaire development practices were used, including performance of a literature review and use of patient and physician focus groups, cognitive debriefing interviews, and pilot testing before validation. Findings from patient and physician focus groups suggest that sensory attributes are relevant to AR patients when choosing INSs. Physician focus groups identified the need for 2 distinct preference instruments, a clinical trial patient preference questionnaire (CTPPQ) and a clinical practice preference questionnaire (CPPPQ). A pilot study suggests that the CTPPQ is capable of discriminating between 2 INSs in the clinical trial setting. Initial findings suggest that items in the CTPPQ and CPPPQ are easy to understand and relevant to patients. Further validation studies with larger sample sizes are needed to assess the psychometric properties of both questionnaires. EBM rating: B-20.
  Otolaryngology Head and Neck Surgery 03/2005; 132(2):197-207. · 1.72 Impact Factor
• Article: Evaluation of patients' preferences for triamcinolone acetonide aqueous, fluticasone propionate, and mometasone furoate nasal sprays in patients with allergic rhinitis.

  Michael Stokes, Stacey L Amorosi, David Thompson, Leon Dupclay, Jorge Garcia, George Georges
  [show abstract] [hide abstract]
  ABSTRACT: To compare product attributes, preferences, and expected compliance associated with triamcinolone acetonide aqueous (TAA-AQ), fluticasone propionate (FP), and mometasone furoate (MF) nasal sprays in patients with allergic rhinitis. Data from 2 randomized, double-blind crossover studies with identical design were pooled (N = 215). Patients completed a 14-item sensory attributes questionnaire immediately after each product, and stated their preference and expected compliance with a prescription after receiving all products. Compared with FP and MF, TAA-AQ was associated with significantly less odor and greater liking of odor ( P < 0.001); and less taste, less dryness of nose/throat, less aftertaste, and greater overall liking ( P < 0.05). Significantly more patients preferred most a prescription of TAA-AQ (50.0%) versus FP (25.0%; P < 0.001) and MF (25.0%; P < 0.001), and would "definitely comply" with TAA-AQ (62.5%) versus FP (49.0%; P < 0.01) and MF (51.0%; P < 0.01). TAA-AQ was associated with significantly more positive sensory attributes, higher preference, and better expected compliance than FP and MF. Patients' preferences for the sensory attributes of an intranasal corticosteroid may affect adherence to treatment.
  Otolaryngology Head and Neck Surgery 09/2004; 131(3):225-31. · 1.72 Impact Factor
• Article: Triamcinolone acetonide aqueous nasal spray improves nocturnal rhinitis-related quality of life in patients treated in a primary care setting: the Quality of Sleep in Allergic Rhinitis study.

  Milton Mintz, Jorge Garcia, Phyllis Diener, Yuning Liao, Leon Dupclay, George Georges
  [show abstract] [hide abstract]
  ABSTRACT: Sleep disturbances due to allergic rhinitis can contribute to daytime fatigue, impair mood, and decrease daytime functioning. To measure allergic rhinitis patients' nocturnal rhinitis-related quality of life using a new, validated disease-specific instrument, the Nocturnal Rhinoconjunctivitis Quality of Life Questionnaire (NRQLQ). This open-label study was conducted in a primary care setting. Adult patients with seasonal or perennial allergic rhinitis rated nocturnal rhinitis-related quality of life using the NRQLQ and sleep disturbances using the Pittsburgh Sleep Quality Index (PSQI) at baseline and after 3 weeks of treatment with triamcinolone acetonide aqueous nasal spray (TAA AQ), 220 microg/d. Changes from baseline in overall and individual domain scores for both the NRQLQ and PSQI were evaluated using t tests for paired differences. The majority of the patients (N = 651) were female (58%), were white (85%), and shared a bed with a partner (63%). Mean +/- SD patient age was 45.7 +/- 15.5 years. TAA AQ treatment was associated with significant improvements in overall NRQLQ score (mean +/- SD change, -1.5 +/- 1.3; P < .001) and in individual domain scores (P < .001 for sleep problems, symptoms during sleep, symptoms upon waking in morning, and practical problems). Similarly, overall and individual PSQI domain scores were statistically significantly improved (P < .001). There were strong correlations between NRQLQ and PSQI scores (all comparisons P < .001). Treatment with TAA AQ for 3 weeks resulted in statistically significant improvements in nocturnal rhinitis-related quality of life and sleep quality in allergic rhinitis patients treated in a primary care setting.
  Annals of allergy, asthma & immunology: official publication of the American College of Allergy, Asthma, & Immunology 03/2004; 92(2):255-61. · 2.83 Impact Factor
• Article: Safety and clinical relief over 1 year with triamcinolone acetonide hydrofluoroalkane-134a nasal aerosol in patients with perennial allergic rhinitis.

  Richard Weber, Jorge Garcia, Rab Faruqi, Donald Banerji, George Georges
  [show abstract] [hide abstract]
  ABSTRACT: The intranasal corticosteroid triamcinolone acetonide (TAA) is an effective treatment for allergic rhinitis (AR). A new hydrofluoroalkane-134a (HFA)-propelled formulation (TAA-HFA) has been approved recently. This study assessed the safety and efficacy of TAA-HFA in patients with perennial AR over 1 year. A total of 396 patients aged 12-69 years with perennial AR (PAR) enrolled in this 1-year, open-label study. Patients received TAA-HFA, 220 microg, once daily for 2 weeks before adjusting their dose to 440 or 110 microg once daily as needed to control symptoms. Doses were standardized to 440 microg across all patients at approximately 4 months. Physical examinations, vital signs, and laboratory measurements were conducted at baseline, 6 months, and study end. Patient and physician global symptom evaluations were performed at visits 3-10. Patients recorded any adverse events (AEs) on daily diary cards. Of the 396 patients enrolled, 349 (88.1%) reported AEs. The most frequently reported AEs were pharyngitis, rhinitis, local reactions, headache, epistaxis, and sinusitis. Most AEs were mild to moderate in intensity; 34 patients discontinued because of AEs. There were no clinically relevant changes in physical examinations, vital signs, or laboratory measurements. A total of four serious AEs were reported; all were recorded as not related to study drug. Mean patient and physician scores of symptom relief showed significant relief from week 2 (visit 3) through the final visit. Long-term administration of TAA-HFA, 440 microg, exhibited a good safety and tolerability profile, while providing moderate-to-complete symptom relief as rated by patients and physicians.
  Allergy and Asthma Proceedings 27(3):243-7. · 2.17 Impact Factor
• Article: Triamcinolone acetonide and fluticasone propionate nasal sprays provide comparable relief of seasonal allergic rhinitis symptoms regardless of disease severity.

  Harold B Kaiser, Yuning Liao, Phyllis Diener, Michael J Leahy, Jorge Garcia, George Georges
  [show abstract] [hide abstract]
  ABSTRACT: The aim of this study was to examine the effects of aqueous triamcinolone acetonide (TAA AQ) and fluticasone propionate (FP) nasal sprays on seasonal allergic rhinitis (SAR) symptoms and health-related quality of life (HRQL) in patients stratified into cohorts based on symptom severity. In a multicenter, investigator-blinded, parallel-group study, 295 patients with a > or =2-year history of SAR received once-daily TAA AQ, 220 microg, or FP, 200 microg, for 3 weeks. Median baseline total nasal symptom score (TNSS; sum of nasal congestion, rhinorrhea, sneezing, and nasal itching scores) for all patients was 8.14 (range, 0-12). Patients were stratified by baseline TNSS into a moderate (<814) or severe (> or =8.14) cohort. Changes from baseline TNSS, individual symptom scores, and HRQL were assessed. Sixty-nine TAA AQ and 76 FP patients were included in the moderate stratum (baseline mean TNSS = 6.14 and 6.22, respectively), and 79 (TAA AQ) and 71 (FP) patients were included in the severe stratum (TNSS = 10.03 and 9.47, respectively). At the study end, patients showed significant (p < 0.0001 all comparisons) and comparable improvements in TNSS in both the moderate (TAA AQ, -2.40 [95% confidence interval [CI, -2.92, -1.87], 39% improvement; FP, -2.22 [95% CI, -2.72, -1.73], 36% improvement) and the severe (TAA AQ, -3.85 [95% CI, -4.36, -3.33], 38% improvement; FP, -3.84 [95% CI, -4.43, -3.24], 41% improvement) strata. TAA AQ and FP significantly and comparably improved HRQL in both strata versus baseline. Once-daily TAA AQ and FP nasal sprays in patients with moderate or severe SAR provided significant and comparable symptom relief and improvements in HRQL.
  Allergy and Asthma Proceedings 25(6):423-8. · 2.17 Impact Factor
• Article: Triamcinolone acetonide and fluticasone propionate aqueous nasal sprays significantly improve nasal airflow in patients with seasonal allergic rhinitis.

  Eli O Meltzer, Carol L Gallet, Alfredo A Jalowayski, Jorge Garcia, Phyllis Diener, Yuning Liao, George Georges
  [show abstract] [hide abstract]
  ABSTRACT: Domiciliary measurement of nasal peak inspiratory flow rate (nPIFR) provides a simple, noninvasive, objective assessment of nasal patency and may be useful for determining the effectiveness of therapeutic interventions. This randomized, parallel-group, investigator-blind study compared the effects of triamcinolone acetonide aqueous nasal spray (TAA AQ), 220 microg everyday (n = 19), and fluticasone propionate (FP AQ), 200 microg everyday (n = 20), for 21 days on nasal airflow in patients with seasonal allergic rhinitis (SAR), using domiciliary nPIFR. Patients had a > or = 2-year history of springtime SAR and positive epicutaneous or intradermal test to grass, tree pollen, or outdoor molds. nPIFR was measured three times each morning (before dosing) and at bedtime using an In-Check nPIF meter. All measurements were recorded on diary cards, and the best of the three measurements was used for data analysis. There were no significant demographic differences between treatment groups at baseline. Baseline nPIFR (+/- SE) was 106.5 L/minute (+/- 51.2) and 97.7 L/minute (+/- 45.0) in the TAA AQ and FP AQ groups, respectively (p = 0.5733). Model-based estimation of mean change from baseline with TAA AQ and FP AQ at the end of the study were 21.72 (+/- 6.04) and 16.48 (+/- 5.73), respectively. Both treatment groups showed an approximately 20% improvement in nPIFR versus baseline (p = 0.0002 and p = 0.0069 for TAA AQ and FP AQ, respectively), with no statistical difference between treatments. Weekly mean nPIFR scores indicated progressive improvement in nasal airflow with both treatments. Both TAA AQ and FP AQ were effective for improving nasal airflow as indicated by increases in nPIFR in patients with SAR.
  Allergy and Asthma Proceedings 25(1):53-8. · 2.17 Impact Factor