Open AccessFormoterol and beclomethasone versus higher dose beclomethasone as maintenance therapy in adult asthma
Author(s) -
Bouros D.,
Bachlitzanakis N.,
Kottakis J,
Pfister P,
Polychronopoulos V,
Papadakis E,
Constantopoulos S,
Froudarakis M.,
Sichletidis L,
Siafakas N.
Publication year - 1999
Publication title -
european respiratory journal
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 4.021
H-Index - 241
eISSN - 1399-3003
pISSN - 0903-1936
DOI - 10.1034/j.1399-3003.1999.14c24.x
Subject(s) - medicine , tolerability , morning , formoterol , anesthesia , inhaler , beclometasone dipropionate , asthma , premedication , confidence interval , metered dose inhaler , corticosteroid , formoterol fumarate , inhalation , randomized controlled trial , adverse effect , budesonide , lung , respiratory disease
A total of 132 adult asthmatics who were symptomatic on 500 µg·day ‐1 inhaled beclomethasone dipropionate (BDP) were studied in an open‐label randomized, parallel group, 12 week, clinical trial. The addition of 12 µg formoterol fumarate solution aerosol (pressurized metered dose inhaler) b.i.d. to BDP at a dose of 500 µg·day ‐1 was compared with a higher dose of 1,000 µg·day ‐1 BDP. Mean morning premedication peak expiratory flow rate (PEF) during the final week of treatment (primary end‐point) increased in both groups compared to baseline. The estimated treatment difference of 20.4 L·min ‐1 (95% confidence interval 3.2–37.6) after 12 weeks of treatment was statistically significant (p<0.05) in favour of the formoterol/BDP group. The overall mean morning premedication PEF for the entire treatment period was higher in the formoterol/BDP group (p=0.002). The overall number of puffs of rescue medication and asthma symptom scores were less in the formoterol/BDP group (p<0.01). Safety and tolerability evaluations were satisfactory in both groups. In conclusion, the results suggest that the addition of formoterol fumarate to the existing dose of an inhaled corticosteroid should be considered as an alternative to increasing the dose of inhaled corticosteroid in the inadequately controlled asthmatic. Eur Respir J 1999; 14: 627–632.