Nebulized formoterol effect on bronchodilation and satisfaction in COPD patients compared to QID ipratropium/albuterol MDI.
OBJECTIVE
Bronchodilator maintenance treatment improves pulmonary function and health-related quality of life in COPD patients. Pulmonary function and patient preference/satisfaction were compared before and after treatment with a short-acting ipratropium/albuterol combination and long-acting nebulized formoterol.


METHODS
A randomized, open-label, crossover trial was conducted at 16 centers in the US. COPD subjects (n=109, 52.8% predicted FEV1) received nebulized formoterol fumarate inhalation solution (Perforomist**, FFIS 20g BID) or ipratropium and albuterol combined in a metered-dose inhaler (MDI) (Combiventy, IPR-ALB, QID) for 2 weeks. After a 1-week washout, subjects were crossed over to the other treatment. Efficacy was assessed with 6-h pulmonary function tests and the transition dyspnea index (TDI). Treatment satisfaction and preference were assessed after treatment. Post-hoc subgroup analyses were conducted by age, gender and COPD severity.


METHODS
Morning pre-dose FEV1 (trough) after 2 weeks of treatment.


RESULTS
FFIS significantly increased morning pre-dose FEV1 relative to IPR-ALB (p = 0.0015). FFIS also improved pre-dose FEV1 beyond that of IPR-ALB in subjects who were older (65 years), male, and with both moderate and severe/very severe COPD. Post-dose efficacy at 6 h was maintained in the FFIS group compared with IPR-ALB (p<or= 0.0001). Patient satisfaction and the perception of disease control were significantly greater with FFIS in the older, male, and severe subgroups. Severe subjects preferred FFIS to IPR-ALB. Both FFIS and IPR-ALB treatments resulted in clinically meaningful changes in dyspnea, but no significant differences were observed between treatments.


CONCLUSIONS
Following a 2-week treatment period, twice-daily nebulized FFIS was significantly more effective in improving lung function than the IPR-ALB combination MDI delivered four times daily. Although the open-label design may limit interpretation of pulmonary function, the crossover design enabled demonstration of greater treatment satisfaction and perception of disease control following nebulized FFIS treatment.


BACKGROUND
Clinicaltrials.gov NCT00462540.
Sutherland
E Rand
ER
National Jewish Health, Denver, CO80206, USA. sutherlande@njhealth.org
Brazinsky
Shari
S
Feldman
Gregory
G
McGinty
Joe
J
Tomlinson
Latanya
L
Denis-Mize
Kimberly
K
D000420:Albuterol / Q000008:administration & dosage / Q000627:therapeutic use*; D001993:Bronchodilator Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D018592:Cross-Over Studies; D004334:Drug Administration Schedule; D004983:Ethanolamines / Q000008:administration & dosage / Q000627:therapeutic use*; D005260:Female; D000068759:Formoterol Fumarate; D006801:Humans; D009241:Ipratropium / Q000008:administration & dosage / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009330:Nebulizers and Vaporizers; D017060:Patient Satisfaction; D029424:Pulmonary Disease, Chronic Obstructive / Q000188:drug therapy*
D001993:Bronchodilator Agents; D004983:Ethanolamines; D009241:Ipratropium; D000420:Albuterol; D000068759:Formoterol Fumarate