| 1. |
- Lundborg, M, et al.
(författare)
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Maintenance plus reliever budesonide/formoterol compared with a higher maintenance dose of budesonide/formoterol plus formoterol as reliever in asthma: an efficacy and cost-effectiveness study
- 2006
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Ingår i: Current Medical Research and Opinion. - 1473-4877. ; 22:5, s. 809-821
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Tidskriftsartikel (refereegranskat)abstract
- Objective: To evaluate efficacy and cost-effectiveness of budesonide/formoterol (Symbicort*) maintenance (one dose once or twice daily) plus additional doses as needed (Symbicort Maintenance And Reliever Therapy, SMART) compared with a higher fixed dose of budesonide/ formoterol with formoterol as needed in patients with persistent asthma. Study design and methods: 6-month, open, randomised study of 465 patients either not well controlled on an inhaled corticosteroid (ICS), or well controlled on a combination of ICS and a long-acting beta(2)-agonist (LABA). Treatments: budesonide/ formoterol 160/4.5 mu g, one inhalation, once or twice daily maintenance plus additional doses as- needed (1 x SMART or 2 x SMART), or budesonide/ formoterol 160/4.5 mu g two inhalations twice daily plus formoterol 4.5 mu g as needed (2 x 2 FIX + F). Children 6-11 years old used an 80/4.5 mu g dose strength. Primary variables of efficacy were the changes in the Asthma Control Questionnaire (ACQ(5)) and morning peak expiratory flow (PEF). Results: Mean age of patients 40 years (range 6-82 years); 53% female. No differences between the groups were found in ACQ(5) scores or asthma exacerbation rates. Morning PEF was higher in the 2 x 2 FIX + F group vs. the 1 x SMART and 2 x SMART groups ( differences 13L/min and 9 L/min, respectively; p < 0.002). The 1 x SMART group showed a significant decrease in asthma controlled days compared with the two other groups. No difference was seen between the 2 x SMART group and the 2 x 2 FIX + F group. Treatment costs were significantly lower in the SMART groups compared with the 2 x 2 FIX + F group. Conclusion: Compared with the 2 x 2 FIX + F treatment the use of budesonide/formoterol was 30-40% lower in the SMART groups while maintaining equal ACQ5 scores. Daily asthma control improved equally with 2 x SMART compared to 2 x 2 FIX + F with a reduction in asthma medication cost. The one dose once daily maintenance treatment (1 x SMART) resulted in a low level of treatment failure (exacerbations) but led to more days with symptoms. Therefore, a daily dose of two inhalations seems to be the lowest appropriate dose in patients with moderate persistent asthma.
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| 2. |
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| 3. |
- Wille-Jørgensen, P., et al.
(författare)
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An interim analysis of recruitment to the COLOFOL trial
- 2009
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Ingår i: Colorectal Disease. - : Wiley. - 1462-8910 .- 1463-1318. ; 10, s. 756-758
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Tidskriftsartikel (refereegranskat)abstract
- OBJECTIVE: To analyse the ongoing process of recruiting patients into a multicenter randomized trial on follow-up after curative surgery for colorectal cancer. The trial is registered in Clinical Trials Registration. METHOD: Prospective registration of all operated patients as well as inclusions (curative resection, stage II or III disease, RESULTS: Between January 2006 and September 2007, 1309 patients have been operated upon. Of these 502 (38.3 %) met the inclusion criteria, 148 (29.5%) had exclusion criteria. Of the final eligible patients 241 (68.1%) were randomized. No specific barriers to inclusion were identified. CONCLUSION: Of an overall population of patients operated for colorectal cancer about one in five were randomized. Bearing the rigorous inclusion and exclusion criteria in mind, this is considered satisfactory, and the investigated population may be representative of patients meeting the inclusion criteria.
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| 4. |
- Wille-Reece, U, et al.
(författare)
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Toll-like receptor agonists influence the magnitude and quality of memory T cell responses after prime-boost immunization in nonhuman primates
- 2006
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Ingår i: The Journal of experimental medicine. - : Rockefeller University Press. - 0022-1007 .- 1540-9538. ; 203:5, s. 1249-1258
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Tidskriftsartikel (refereegranskat)abstract
- There is a remarkable heterogeneity in the functional profile (quality) of T cell responses. Importantly, the magnitude and/or quality of a response required for protection may be different depending on the infection. Here, we assessed the capacity of different Toll like receptor (TLR)-binding compounds to influence T helper cell (Th)1 and CD8+ T cell responses when used as adjuvants in nonhuman primates (NHP) with HIV Gag as a model antigen. NHP were immunized with HIV Gag protein emulsified in Montanide ISA 51, an oil-based adjuvant, with or without a TLR7/8 agonist, a TLR8 agonist, or the TLR9 ligand cytosine phosphate guanosine oligodeoxynucleotides (CpG ODN), and boosted 12 wk later with a replication-defective adenovirus-expressing HIV-Gag (rAD-Gag). Animals vaccinated with HIV Gag protein/Montanide and CpG ODN or the TLR7/8 agonist had higher frequencies of Th1 responses after primary immunization compared to all other vaccine groups. Although the rAD-Gag boost did not elevate the frequency of Th1 memory cytokine responses, there was a striking increase in HIV Gag-specific CD8+ T cell responses after the boost in all animals that had received a primary immunization with any of the TLR adjuvants. Importantly, the presence and type of TLR adjuvant used during primary immunization conferred stability and dramatically influenced the magnitude and quality of the Th1 and CD8+ T cell responses after the rAD-Gag boost. These data provide insights for designing prime-boost immunization regimens to optimize Th1 and CD8+ T cell responses.
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