Efficacy and safety of birch pollen allergoid subcutaneous immunotherapy: A 2-year double-blind, placebo-controlled, randomized trial plus 1-year open-label extension.

BACKGROUND: Previous clinical trials with birch pollen subcutaneous immunotherapy have been conducted over a 1- to 2-year treatment period and involved mostly a single geographic location. OBJECTIVE: This study (EudraCT-Number: 2005-000025-35) intended to evaluate the effect of subcutaneous immunotherapy with high-dose hypoallergenic birch pollen allergoid in patients with confirmed moderate to severe seasonal allergic rhinitis/rhinoconjunctivitis over a 3-year course in 19 European centres. METHODS: Adults with confirmed birch pollen allergy (n = 253) were randomized to preseasonal placebo (n = 129) or active treatment (n = 124). Primary endpoint was change in Symptom Medication Score after 2 years treatment (2007). RESULTS: The change in Symptom Medication Score of active- vs placebo-treated patients for the Full Analysis Set (n = 227, 15.2% reduction, P = 0.0710) and Per-Protocol Set (n = 216, 16.7% reduction, P = 0.0523) showed a positive trend, although significance was not achieved. The primary endpoint, assessed in 2007, coincided with the lowest pollination during the study period. In a subgroup analysis of patients in the north-eastern region (n = 102), where birch is the major tree and consequently patients' exposure is higher, changes in Symptom Medication Score (32.7% reduction, P = 0.0034) and median number of well days (P = 0.0232) were highly significant in favour of the active group. During the open-label third year of treatment, the mean Symptom Medication Score of active-treated patients was further reduced despite an increased pollen count. Subcutaneous immunotherapy was well tolerated and consistent with the known safety profile. CONCLUSIONS AND CLINICAL RELEVANCE: Although the primary endpoint was not reached for the Full Analysis Set, a significant and clinically relevant effect on Symptom Medication Score was clearly demonstrated for the subgroup of patients in the north-eastern region of Europe, where birch is the predominant tree species. Proving efficacy of birch allergen subcutaneous immunotherapy is challenging due to the numerous factors influencing birch pollen allergen exposure in field studies.

Healing results of prolonged acute frontal sinusitis treated with endoscopic sinus surgery.

In a marked part of patients suffering from acute frontal sinusitis, the symptoms do not resolve after initial therapy (antibiotics and/or trephination). The prolongation of the healing or recurrences may be caused by persistent inflammation or by structural abnormalities at the nasofrontal connection. During the last decade endoscopic surgery (FES) has become a very useful method to restore the frontonasal drainage although long term results of this kind of population are rare. We evaluated the results of endoscopic surgery in two patient groups (total number of 50) both operated after prolongation (persistent symptoms after 4 weeks) of the initial acute phase of the frontal sinusitis. The first group (A, 15 patients, first trephined) was followed-up 4 years, the number of recurrences after the first FES was 60% and in the other group (B, no initial trephination) with over 6 months follow-up, 91% of patients had recurrences. In group A pre- and postoperative CT-scanning was used to determine the possible anatomical variations that could be causing the failures. All but 3 patients showed some kind of abnormal anatomical variation. In group B only preoperative CT was done. In most cases the reasons for recurrences of frontal sinusitis were polyps and/or chronic inflammation at the ethmoidal region.

LUPP relieves partial upper airway obstruction during sleep in patients with velopharyngeal narrowing.

CONCLUSION: Patients with upper airway narrowing at the soft palate level and partial upper airway obstruction during sleep seem to benefit from laser-assisted uvulopalatoplasty (LUPP) in terms of decreased velopharyngeal collapsibility and improved nocturnal breathing. OBJECTIVES: The current operative treatments for obstructive sleep apnea syndrome (OSAS) are not very effective compared with continuous positive airway pressure (CPAP). It has been suggested that active treatment should be performed earlier, when sleep apnea is present in a milder form. The main problem is identifying progressive sleep apnea. The present study assessed the efficacy of LUPP in patients with partial upper airway obstruction during sleep diagnosed by means of a static charge-sensitive bed (SCSB) combined with oxyhemoglobin desaturation recording and digital fluoroscopy-based collapsibility estimation. METHODS: LUPP was carried out in 27 patients under local anesthesia as day surgery. Digital fluoroscopy and SCSB were recorded preoperatively and 6 months after LUPP. RESULTS: Partial upper airway obstruction events and arterial oxyhemoglobin desaturations during sleep decreased significantly. Digital fluoroscopy revealed that the minimal anteroposterior dimension increased and collapsibility decreased at the level where velopharyngeal obstruction occurred, the soft palate.