Table 2.

Inclusion criteria and definitions of studies using fluticasone propionate and salmeterol

	Treatment	Inclusion criteria	Exacerbation definition
Mahler et al 2002	Salmeterol/fluticasone versus fluticasone propionate, salmeterol or placebo	FEV1/FVC ≤ 70% FEV1<65% predicted normal and >0.70L	Exacerbation was defined by treatment and resulted in withdrawal from the study
Hanania et al 2003	Salmeterol/fluticasone versus fluticasone propionate, salmeterol or placebo	FEV1/FVC ≤ 70% FEV1<65% predicted normal and >0.70L	Moderate exacerbation: requiring treatment with. antibiotics and/or corticosteroids
			Severe exacerbation: requiring hospitalization
			Discontinuation after 1 exacerbation with inhaled or oral corticosteroids or hospitalization or 3 exacerbations treated with antibiotics
TRISTAN Calverley et al 2003a	Salmeterol/fluticasone versus fluticasone propionate, salmeterol or placebo	FEV1/FVC ≤ 70% FEV1 25%–70% predicted normal	Exacerbation: a worsening of COPD symptoms that required treatment with antibiotics, oral corticosteroids or both. Episodes that required corticosteroids treatment of hospital admission were noted separately.
		Reversibility after 400 μg salbutamol: <10% of predicted normal.
		At least one exacerbation per year in the last three years.
		At least one exacerbation in the year immediately before the trial entry requiring treatment with oral corticosteroids, antibiotics or both.
Dal Negro et al 2003	Salmeterol/fluticasone versus salmeterol or placebo	FEV1/FVC ≤ 70% FEV1 ≤ 80% predicted normal and >0,80L	Mild exacerbation: condition requiring salbutamol prn >2 occasions/24 h period on 2 or more consecutive days compared with the baseline mean of last 7 days of run-in;
		Reversibility after 400 μg salbutamol: ≤ 12% as a percent of predicted normal Regular treatment with 200 mg theophylline bid	Moderate exacerbations: condition requiring treatment with antibiotics and/or oral corticosteroids; Severe exacerbations: condition requiring emergency hospital treatment and/or hospitalization.

Abbreviations: COPD, chronic obstructive pulmonary disease; FEV₁, forced expiratory volume in one second; FVC, forced vital capacity