The European respiratory journal : official journal of the European Society for Clinical Respiratory Physiology
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Randomized Controlled Trial Multicenter Study Comparative Study Clinical Trial
Incidence of acute decreases in peak expiratory flow following the use of metered-dose inhalers in asthmatic patients.
This study aimed to investigate and compare the incidence of metered-dose inhaler (MDI)-associated bronchoconstriction in an asthmatic population, following the use of three different MDIs. Two different placebo metered-dose inhaler preparations containing the same chlorofluorocarbons but differing in dispersant chemicals, one containing oleic acid (MDI-OA) and the other lecithin NF (MDI-L), were compared with a MDI containing salmeterol xinafoate (25 micrograms) and lecithin NF (MDI-S). The study population comprised 11,850 asthmatic patients, who were assigned to receive two puffs from one of the three inhalers: MDI-S (n = 3,948); MDI-L (n = 3,942); or MDI-OA (n = 3,960). ⋯ The risk of acute bronchoconstriction was also shown to increase with age and with decreasing pretreatment PEF. The study has shown that acute bronchoconstriction is an uncommon adverse reaction following the use of metered-dose inhalers. In addition, the study suggests that one of the inert constituents currently within metered-dose inhalers is the likely source of the irritant leading to bronchoconstriction.
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Randomized Controlled Trial Multicenter Study Clinical Trial
Sequential treatment with low dose almitrine bismesylate in hypoxaemic chronic obstructive airways disease.
Daily dose schedules of 100-200 mg of almitrine bismesylate improve arterial blood gases in patients with hypoxaemic chronic obstructive airways disease (COPD) but dose related side effects are evident. In the present study, daily doses approximately half of those previously used were employed in a randomised double blind manner in 85 patients (age 35-79 years) with hypoxaemic COPD. After a one month period to check stability of arterial blood gases, patients were allocated to almitrine (A) or placebo (P) using an unequal code (60% A, 40% P). ⋯ After withdrawal of therapy arterial blood gases and spirometry reverted to pre-treatment levels, suggesting no permanent reversal of pathophysiology. Dose related side effects of breathlessness, indigestion and peripheral neuropathy were not observed. Nerve conduction studies revealed no difference in peripheral nerve dysfunction in hypoxaemic COPD between active and placebo therapy.(ABSTRACT TRUNCATED AT 250 WORDS)
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Randomized Controlled Trial Multicenter Study Clinical Trial
Bronchodilator reversibility, exercise performance and breathlessness in stable chronic obstructive pulmonary disease.
Partial bronchodilator reversibility can be demonstrated in many patients with stable chronic obstructive pulmonary disease (COPD), but its relevance to exercise capacity and symptoms is uncertain. Previous data suggest that anticholinergic bronchodilators do not improve exercise tolerance in such patients. We studied 32 patients with stable COPD, mean age 65 yrs, in a double-blind, placebo-controlled, cross-over trial of the inhaled anticholinergic drug, oxitropium bromide. ⋯ Oxitropium bromide increased baseline FEV1 from 0.70 (0.28) l (mean (SD)) to 0.88 (0.36) l. The 6 min walking distance increased by 7% compared with placebo, whilst resting breathlessness scores fell from 2.0 to 1.23 at rest and 4.09 to 3.28 at the end of exercise after the active drug. Improvements in walking distances and symptoms were unrelated to changes in either FEV1 or FVC, indicating that routine reversibility testing is not a good predictor of symptomatic benefit in these patients.
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Multicenter Study Comparative Study Clinical Trial
Sleep-related oxygen desaturation and daytime pulmonary haemodynamics in COPD patients.
It has been hypothesized that in chronic obstructive pulmonary disease (COPD), sleep-related hypoxaemia could lead to pulmonary hypertension (PH) and cor pulmonale, even in patients with only mild daytime hypoxaemia. We investigated the relationships between sleep variables and daytime pulmonary haemodynamics in 40 COPD patients with daytime arterial oxygen tension (PaO2) between 60-70 mmHg (8-9.3 kPa). Patients were considered as desaturators if they spent at least 30% of the sleep recording time with a transcutaneous O2 saturation (StcO2) less than 90%. ⋯ The PH patients (n = 6), all desaturators, differed from the desaturators with no PH (n = 12), and from ND (n = 22) in having higher numbers of desaturation dips, longer durations of dips, and lower mean nocturnal arterial oxygen saturation (SaO2). We conclude that a causal relation between nocturnal desaturation and permanent PH is very likely. Further studies are needed to see whether oxygen therapy can prevent PH in these patients.
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Multicenter Study Clinical Trial Controlled Clinical Trial
Two years treatment with almitrine bismesylate in patients with hypoxic chronic obstructive airways disease.
Eighty nine patients with hypoxic chronic obstructive airways disease (COAD) were enrolled into the 1 year Vectarion International Multicentre Study-VIMS in 4 centres, Sheffield (UK), and Antwerp, Liege and Namur (Belgium). At the end of the year the remainder were invited to continue taking placebo or almitrine bismesylate (100-200 mg daily) in the same double blind manner for a further 12 months. In the almitrine treated patients mean arterial oxygen tension (Pao2) at the end of the treatment period improved from 7.5 (0.5) kPa to 8.2 (1.3) kPa (p less than 0.01) and arterial carbon dioxide tension (Paco2) fell from 6.1 (0.8) kPa to 5.8 (0.9) kPa (p less than 0.01). ⋯ In conclusion, 2 yrs of almitrine treatment (100-200 mg daily) leads to a persistent slight improvement in PaO2 and PaCO2 but no benefit in survival was demonstrated. Patients in this study had a high incidence of drug related side-effects. Lower dose schedules should be investigated.