The safety and efficacy of long-acting muscarinic antagonists have been studied in chronic obstructive pulmonary disease (COPD) patients. The ASCENT-COPD is a multicentre, randomised, placebo-controlled, double-blind trial which evaluated the effect of aclidinium bromide on major adverse cardiovascular events (MACE) and exacerbations in high-risk COPD patients. The primary safety endpoint was time to first MACE during the course of 3 years. The primary efficacy endpoint was the annual COPD exacerbation rate during the first year of treatment. The results showed that, among patients with COPD and increased cardiovascular risk, aclidinium was not inferior to placebo for risk of MACE over 3 years and the rate of moderate-to-severe COPD exacerbations was reduced over the first year.
The effect of dexamethasone (4 mg orally, twice daily) on nocturnal oxygenation in COPD lowlanders travelling to 3,100 meters was evaluated in a randomised, placebo-controlled, double-blind trial (n=118). The primary outcome was the difference in altitude-induced nocturnal oxygen saturation at 3,100 meters between patients receiving dexamethasone and those receiving placebo. Other outcomes were apnoea/hypopnoea, subjective sleep quality and clinical evaluations. The results showed that in lowlanders of Central Asia with COPD travelling to high altitude, preventive dexamethasone treatment improved nocturnal oxygen saturation, sleep apnoea and subjective sleep quality.
The last study presented a randomised placebo-controlled trial to evaluate the effect of supplementation with high doses of vitamin D during pregnancy on the development of asthma in children at the age of 6 years. During week 24 of pregnancy, women were randomised to receive 2,400 IU/d of vitamin D or placebo in addition to the recommended intake of 400 IU/d of vitamin D. At the age of 6 years, 545 children were evaluated. No significant differences were observed for lung function outcomes, bronchial reactivity, fractional exhaled nitric oxygen concentration, allergic sensitisation or rhinitis.