Given the established role of mast cells in allergic respiratory responses within the lung, and their participation in altering airway physiology in asthma, we examined a subset of subjects in the ACRN Salmeterol or Corticosteroids (SOCS) trial to evaluate whether mast-cell numbers, or mast-cell mediator release, were also markers that could be associated with treatment in Canada Pharmacy  failure after cessation of ICS.  allergic respiratory

Materials and Methods

Subjects

Subjects with asthma, as defined by the American Thoracic Society, who met recommended criteria for treatment with ICS were recruited. Exclusion criteria included a > 5 pack-year cigarette smoking history or any cigarette use in the last year, use of any other medications except oral contraceptives and nasal beclomethasone, and/or an upper respiratory infection within 6 weeks of study.

Study Design

The SOCS trial was conducted by the ACRN between February 1997 and December 1998. This trial was a 28-week, randomized, double-blind, double-dummy, placebo-controlled, prospective, multicenter trial in subjects with persistent asthma comparing the efficacy of ICS (TAA, 400 pg bid), an inhaled long-acting P-adrenergic agonist (salmeterol xinafoate, 42 pg bid) and placebo, during 16 weeks of therapy ED with Cialis Online , and for 6 weeks following cessation of therapy. Subjects entered a 6-week run-in during which they received TAA, 400 pg or four puffs bid. At the end of the run-in, those subjects whose FEV1 was > 80% predicted, whose average peak expiratory flow (PEF) variability was < 20% and who demonstrated > 85% compliance with twice-daily PEF measurements were randomized.

Compliance was determined by evaluating diary cards and use of the Airwatch device (Enact; Palo Alto, CA). A subject was considered compliant if the TAA four puffs bid was logged correctly in the diary cards during the run-in and the Airwatch device was used prior to TAA administration. If TAA was recorded less than twice daily on > 12 days, the subjects were not randomized. Those subjects who met the above criteria were randomized to receive either TAA (400 pg bid or four puffs bid plus two puffs bid salmeterol placebo), salmeterol (42 pg bid or two puffs bid plus four puffs bid TAA placebo) or placebo (two puffs bid of salmeterol placebo and four puffs bid of TAA placebo) for the next 16 weeks, using a double-dummy, blinding technique (Fig 1).

Categories: Allergy