Cilomilast: Orally Active Selective Phosphodiesterase-4 Inhibitor for Treatment of Chronic Obstructive Pulmonary Disease

Shaunta' D Martina, PharmD; Maha S Ismail; Kimi S Vesta, PharmD BCPS

The Annals of Pharmacotherapy. 2006;40(10):1822-1828.

Abstract and Introduction

Abstract

Objective: To review available literature evaluating the pharmacology, pharmacokinetics, clinical efficacy, and adverse effects of cilomilast, a selective phosphodiesterase-4 (PDE4) inhibitor.
Data Sources: Literature was accessed through MEDLINE (1966-May 2006), Current Contents Clinical Medicine (1998-May 2006), and The Cochrane Library Database (1st quarter 2006) using the terms cilomilast, Ariflo, and SB 207 499. Reference lists from retrieved articles and information from the manufacturer were manually reviewed.
Study Selection And Data Extraction: All clinical trials evaluating cilomilast and published in English were included in this review. In addition, articles evaluating the pharmacology, pharmacokinetics, and safety of cilomilast in humans were reviewed.
Data Synthesis: Cilomilast is a second-generation PDE4 inhibitor with antiinflammatory effects that target bronchoconstriction, mucus hypersecretion, and airway remodeling associated with chronic obstructive pulmonary disease (COPD). Selective PDE4 inhibition is proposed to maximize the antiinflammatory effects of PDE inhibition while minimizing the adverse effects of nonselective agents. To date, 4 clinical trials have evaluated the efficacy of cilomilast and demonstrated improvement in lung function (forced expiratory volume in 1 second) and quality of life and reduction in the occurrence of COPD exacerbations compared with placebo. Cilomilast is generally well tolerated, with adverse effects being overall mild and self-limiting.
Conclusions: COPD is a progressive disease, and available treatment options provide limited efficacy. Given its unique mechanism of action and improved adverse effect profile compared with previous agents, cilomilast may have a promising role for the management of COPD.

Introduction

Phosphodiesterase (PDE) inhibitors, such as theophylline, have been used to treat chronic obstructive pulmonary disease (COPD) for decades; however, the clinical benefits of these agents have never been established to out-weigh the risks of their numerous adverse effects.^[1,2] The identification of several distinct PDE isoenzymes has led to the discovery of medications with safer risk-to-benefit profiles, including cilomilast.^[3] This article reviews available literature evaluating the pharmacology, pharmacokinetics, clinical efficacy, and adverse effects of cilomilast (Ariflo, GlaxoSmithKline), a selective PDE4 inhibitor. Currently, cilomilast is in Phase III clinical trials and is not approved in the US. The Food and Drug Administration (FDA) issued an approvable letter in October 2003 requesting additional safety and efficacy data from the manufacturer.

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Cite this: Cilomilast: Orally Active Selective Phosphodiesterase-4 Inhibitor for Treatment of Chronic Obstructive Pulmonary Disease - Medscape - Oct 01, 2006.

Table 1. Cilomilast Efficacy Trials
Reference	Objective	Results
Reference	Objective	Primary Outcomes	Secondary Outcomes
Rennard (2006)^[10]	to assess the efficacy, safety, and tolerability of cilomilast 15 mg po bid over 24 wk in COPD pts.	mean FEV₁ change from baseline at 24 wk: cilomilast +10 mL vs placebo -70 mL (p < 0.001)	trough FVC change from baseline at 24 wk: 110 mL difference in favor of cilomilast (p = 0.001)
		SGRQ total score averaged over 24 wk: cilomilast improved ~3.6 points vs placebo worsened ~0.5 points (p < 0.001)	pts. exacerbation-free at 24 wk: cilomilast 74% vs placebo 62% (p = 0.008)
			postexercise dyspnea score average over 24 wk: cilomilast -0.17 vs placebo +0.07 (p = 0.029)
			6 min walk distance: no difference
			summary symptom scores: no difference
Compton (2001)^[11]	to assess the safety, efficacy, and dose response of cilomilast 5, 10, and 15 mg bid over 6 wk in COPD pts.	prebronchodilator FEV₁ change from baseline at 6 wk: cilomilast 15 mg +160 mL (p < 0.0001 vs placebo); no improvement with 5 mg or 10 mg vs placebo	mean PEF change from baseline at 6 wk: cilomilast 15 mg +34.1 L/min (p < 0.0001 vs placebo); no improvement with 5 mg or 10 mg vs placebo
		postbronchodilator FEV₁ change from baseline at 6 wk: cilomilast 15 mg +100 mL (p < 0.0096 vs placebo); no improvement with 5 mg or 10 mg vs placebo	mean FVC change from baseline at 6 wk: cilomilast 15 mg +190 mL (p = 0.001 vs placebo); no improvement with 5 mg or 10 mg vs placebo
			SGRQ total score at 6 wk: cilomilast 15 mg improved by 3.9 points (p = NS vs placebo); no improvement with 5 mg or 10 mg vs placebo
			first dose FEV₁ change from baseline at 4 h: cilomilast 15 mg +80 mL (p = 0.0089 vs placebo); no results in 5 mg or 10 mg groups reported
Grootendorst (2003)^[12]	to estimate the difference in first-dose bronchodilation between single-dose cilomilast 15 mg and placebo 8 h after administration and between a single dose of cilomilast 15 mg and cilomilast 15 mg with inhaled bronchodilators (albuterol, ipratropium, albuterol with ipratropium) in COPD pts.	maximum FEV₁ change from baseline at 8 h: cilomilast 15 mg +140 mL vs placebo +152 mL (p = NS); vs cilomilast/albuterol +132.1 mL (p < 0.01); vs cilomilast/ipratropium +148.4 mL (p < 0.01); vs cilomilast/albuterol/ipratropium +231.1 mL (p < 0.01)	AUC for increase in FEV₁: cilomilast 15 mg -4.7 mL (p = NS vs placebo); cilomilast/albuterol +88.6 mL (p < 0.01 vs cilomilast); cilomilast/ipratropium +116.4 mL (p < 0.01 vs cilomilast); cilomilast/albuterol/ipratropium +169.5 mL (p < 0.01 vs cilomilast)
Gamble (2003)^[13]	to evaluate effects on airway inflammation of cilomilast 15 mg bid for 12 wk in COPD pts.	change from baseline neutrophil % in induced sputum after 12 wk: no difference	mean change from baseline biopsy numbers of CD8+ cells at 10 wk: cilomilast -185/mm² vs placebo +27.7/mm² (p = 0.001)
			mean change from baseline biopsy numbers of CD68+ cells at 10 wk: cilomilast -21.1/mm² vs placebo +25.3/mm² (p = 0.039)
			mean change from baseline biopsy numbers of epithelial neutrophils at 10 wk: cilomilast +0.9/0.1 mm² vs placebo -0.8/0.1 mm² (p = 0.597)
			mean change from baseline biopsy numbers of subepithelial neutrophils at 10 wk: cilomilast +3.2/mm² vs placebo +18.3/mm² (p = 0.496)
			mean change from baseline FEV₁ at 8 wk: cilomilast +40 mL vs placebo -90 mL (p = 0.02)
			mean change from baseline FEV₁ at 12 wk: cilomilast +10 mL vs placebo -60 mL (p = 0.16)

COPD = chronic obstructive pulmonary disease; FEV₁ = forced expiratory volume in 1 second; FVC = forced vital capacity; PEF = peak expiratory flow; SGRQ = St George's Respiratory Questionnaire

Table 1. Cilomilast Efficacy Trials
Reference	Objective	Results
Reference	Objective	Primary Outcomes	Secondary Outcomes
Rennard (2006)^[10]	to assess the efficacy, safety, and tolerability of cilomilast 15 mg po bid over 24 wk in COPD pts.	mean FEV₁ change from baseline at 24 wk: cilomilast +10 mL vs placebo -70 mL (p < 0.001)	trough FVC change from baseline at 24 wk: 110 mL difference in favor of cilomilast (p = 0.001)
		SGRQ total score averaged over 24 wk: cilomilast improved ~3.6 points vs placebo worsened ~0.5 points (p < 0.001)	pts. exacerbation-free at 24 wk: cilomilast 74% vs placebo 62% (p = 0.008)
			postexercise dyspnea score average over 24 wk: cilomilast -0.17 vs placebo +0.07 (p = 0.029)
			6 min walk distance: no difference
			summary symptom scores: no difference
Compton (2001)^[11]	to assess the safety, efficacy, and dose response of cilomilast 5, 10, and 15 mg bid over 6 wk in COPD pts.	prebronchodilator FEV₁ change from baseline at 6 wk: cilomilast 15 mg +160 mL (p < 0.0001 vs placebo); no improvement with 5 mg or 10 mg vs placebo	mean PEF change from baseline at 6 wk: cilomilast 15 mg +34.1 L/min (p < 0.0001 vs placebo); no improvement with 5 mg or 10 mg vs placebo
		postbronchodilator FEV₁ change from baseline at 6 wk: cilomilast 15 mg +100 mL (p < 0.0096 vs placebo); no improvement with 5 mg or 10 mg vs placebo	mean FVC change from baseline at 6 wk: cilomilast 15 mg +190 mL (p = 0.001 vs placebo); no improvement with 5 mg or 10 mg vs placebo
			SGRQ total score at 6 wk: cilomilast 15 mg improved by 3.9 points (p = NS vs placebo); no improvement with 5 mg or 10 mg vs placebo
			first dose FEV₁ change from baseline at 4 h: cilomilast 15 mg +80 mL (p = 0.0089 vs placebo); no results in 5 mg or 10 mg groups reported
Grootendorst (2003)^[12]	to estimate the difference in first-dose bronchodilation between single-dose cilomilast 15 mg and placebo 8 h after administration and between a single dose of cilomilast 15 mg and cilomilast 15 mg with inhaled bronchodilators (albuterol, ipratropium, albuterol with ipratropium) in COPD pts.	maximum FEV₁ change from baseline at 8 h: cilomilast 15 mg +140 mL vs placebo +152 mL (p = NS); vs cilomilast/albuterol +132.1 mL (p < 0.01); vs cilomilast/ipratropium +148.4 mL (p < 0.01); vs cilomilast/albuterol/ipratropium +231.1 mL (p < 0.01)	AUC for increase in FEV₁: cilomilast 15 mg -4.7 mL (p = NS vs placebo); cilomilast/albuterol +88.6 mL (p < 0.01 vs cilomilast); cilomilast/ipratropium +116.4 mL (p < 0.01 vs cilomilast); cilomilast/albuterol/ipratropium +169.5 mL (p < 0.01 vs cilomilast)
Gamble (2003)^[13]	to evaluate effects on airway inflammation of cilomilast 15 mg bid for 12 wk in COPD pts.	change from baseline neutrophil % in induced sputum after 12 wk: no difference	mean change from baseline biopsy numbers of CD8+ cells at 10 wk: cilomilast -185/mm² vs placebo +27.7/mm² (p = 0.001)
			mean change from baseline biopsy numbers of CD68+ cells at 10 wk: cilomilast -21.1/mm² vs placebo +25.3/mm² (p = 0.039)
			mean change from baseline biopsy numbers of epithelial neutrophils at 10 wk: cilomilast +0.9/0.1 mm² vs placebo -0.8/0.1 mm² (p = 0.597)
			mean change from baseline biopsy numbers of subepithelial neutrophils at 10 wk: cilomilast +3.2/mm² vs placebo +18.3/mm² (p = 0.496)
			mean change from baseline FEV₁ at 8 wk: cilomilast +40 mL vs placebo -90 mL (p = 0.02)
			mean change from baseline FEV₁ at 12 wk: cilomilast +10 mL vs placebo -60 mL (p = 0.16)

COPD = chronic obstructive pulmonary disease; FEV₁ = forced expiratory volume in 1 second; FVC = forced vital capacity; PEF = peak expiratory flow; SGRQ = St George's Respiratory Questionnaire

Table 1. Cilomilast Efficacy Trials
Reference	Objective	Results
Reference	Objective	Primary Outcomes	Secondary Outcomes
Rennard (2006)^[10]	to assess the efficacy, safety, and tolerability of cilomilast 15 mg po bid over 24 wk in COPD pts.	mean FEV₁ change from baseline at 24 wk: cilomilast +10 mL vs placebo -70 mL (p < 0.001)	trough FVC change from baseline at 24 wk: 110 mL difference in favor of cilomilast (p = 0.001)
		SGRQ total score averaged over 24 wk: cilomilast improved ~3.6 points vs placebo worsened ~0.5 points (p < 0.001)	pts. exacerbation-free at 24 wk: cilomilast 74% vs placebo 62% (p = 0.008)
			postexercise dyspnea score average over 24 wk: cilomilast -0.17 vs placebo +0.07 (p = 0.029)
			6 min walk distance: no difference
			summary symptom scores: no difference
Compton (2001)^[11]	to assess the safety, efficacy, and dose response of cilomilast 5, 10, and 15 mg bid over 6 wk in COPD pts.	prebronchodilator FEV₁ change from baseline at 6 wk: cilomilast 15 mg +160 mL (p < 0.0001 vs placebo); no improvement with 5 mg or 10 mg vs placebo	mean PEF change from baseline at 6 wk: cilomilast 15 mg +34.1 L/min (p < 0.0001 vs placebo); no improvement with 5 mg or 10 mg vs placebo
		postbronchodilator FEV₁ change from baseline at 6 wk: cilomilast 15 mg +100 mL (p < 0.0096 vs placebo); no improvement with 5 mg or 10 mg vs placebo	mean FVC change from baseline at 6 wk: cilomilast 15 mg +190 mL (p = 0.001 vs placebo); no improvement with 5 mg or 10 mg vs placebo
			SGRQ total score at 6 wk: cilomilast 15 mg improved by 3.9 points (p = NS vs placebo); no improvement with 5 mg or 10 mg vs placebo
			first dose FEV₁ change from baseline at 4 h: cilomilast 15 mg +80 mL (p = 0.0089 vs placebo); no results in 5 mg or 10 mg groups reported
Grootendorst (2003)^[12]	to estimate the difference in first-dose bronchodilation between single-dose cilomilast 15 mg and placebo 8 h after administration and between a single dose of cilomilast 15 mg and cilomilast 15 mg with inhaled bronchodilators (albuterol, ipratropium, albuterol with ipratropium) in COPD pts.	maximum FEV₁ change from baseline at 8 h: cilomilast 15 mg +140 mL vs placebo +152 mL (p = NS); vs cilomilast/albuterol +132.1 mL (p < 0.01); vs cilomilast/ipratropium +148.4 mL (p < 0.01); vs cilomilast/albuterol/ipratropium +231.1 mL (p < 0.01)	AUC for increase in FEV₁: cilomilast 15 mg -4.7 mL (p = NS vs placebo); cilomilast/albuterol +88.6 mL (p < 0.01 vs cilomilast); cilomilast/ipratropium +116.4 mL (p < 0.01 vs cilomilast); cilomilast/albuterol/ipratropium +169.5 mL (p < 0.01 vs cilomilast)
Gamble (2003)^[13]	to evaluate effects on airway inflammation of cilomilast 15 mg bid for 12 wk in COPD pts.	change from baseline neutrophil % in induced sputum after 12 wk: no difference	mean change from baseline biopsy numbers of CD8+ cells at 10 wk: cilomilast -185/mm² vs placebo +27.7/mm² (p = 0.001)
			mean change from baseline biopsy numbers of CD68+ cells at 10 wk: cilomilast -21.1/mm² vs placebo +25.3/mm² (p = 0.039)
			mean change from baseline biopsy numbers of epithelial neutrophils at 10 wk: cilomilast +0.9/0.1 mm² vs placebo -0.8/0.1 mm² (p = 0.597)
			mean change from baseline biopsy numbers of subepithelial neutrophils at 10 wk: cilomilast +3.2/mm² vs placebo +18.3/mm² (p = 0.496)
			mean change from baseline FEV₁ at 8 wk: cilomilast +40 mL vs placebo -90 mL (p = 0.02)
			mean change from baseline FEV₁ at 12 wk: cilomilast +10 mL vs placebo -60 mL (p = 0.16)

COPD = chronic obstructive pulmonary disease; FEV₁ = forced expiratory volume in 1 second; FVC = forced vital capacity; PEF = peak expiratory flow; SGRQ = St George's Respiratory Questionnaire

Table 1. Cilomilast Efficacy Trials
Reference	Objective	Results
Reference	Objective	Primary Outcomes	Secondary Outcomes
Rennard (2006)^[10]	to assess the efficacy, safety, and tolerability of cilomilast 15 mg po bid over 24 wk in COPD pts.	mean FEV₁ change from baseline at 24 wk: cilomilast +10 mL vs placebo -70 mL (p < 0.001)	trough FVC change from baseline at 24 wk: 110 mL difference in favor of cilomilast (p = 0.001)
		SGRQ total score averaged over 24 wk: cilomilast improved ~3.6 points vs placebo worsened ~0.5 points (p < 0.001)	pts. exacerbation-free at 24 wk: cilomilast 74% vs placebo 62% (p = 0.008)
			postexercise dyspnea score average over 24 wk: cilomilast -0.17 vs placebo +0.07 (p = 0.029)
			6 min walk distance: no difference
			summary symptom scores: no difference
Compton (2001)^[11]	to assess the safety, efficacy, and dose response of cilomilast 5, 10, and 15 mg bid over 6 wk in COPD pts.	prebronchodilator FEV₁ change from baseline at 6 wk: cilomilast 15 mg +160 mL (p < 0.0001 vs placebo); no improvement with 5 mg or 10 mg vs placebo	mean PEF change from baseline at 6 wk: cilomilast 15 mg +34.1 L/min (p < 0.0001 vs placebo); no improvement with 5 mg or 10 mg vs placebo
		postbronchodilator FEV₁ change from baseline at 6 wk: cilomilast 15 mg +100 mL (p < 0.0096 vs placebo); no improvement with 5 mg or 10 mg vs placebo	mean FVC change from baseline at 6 wk: cilomilast 15 mg +190 mL (p = 0.001 vs placebo); no improvement with 5 mg or 10 mg vs placebo
			SGRQ total score at 6 wk: cilomilast 15 mg improved by 3.9 points (p = NS vs placebo); no improvement with 5 mg or 10 mg vs placebo
			first dose FEV₁ change from baseline at 4 h: cilomilast 15 mg +80 mL (p = 0.0089 vs placebo); no results in 5 mg or 10 mg groups reported
Grootendorst (2003)^[12]	to estimate the difference in first-dose bronchodilation between single-dose cilomilast 15 mg and placebo 8 h after administration and between a single dose of cilomilast 15 mg and cilomilast 15 mg with inhaled bronchodilators (albuterol, ipratropium, albuterol with ipratropium) in COPD pts.	maximum FEV₁ change from baseline at 8 h: cilomilast 15 mg +140 mL vs placebo +152 mL (p = NS); vs cilomilast/albuterol +132.1 mL (p < 0.01); vs cilomilast/ipratropium +148.4 mL (p < 0.01); vs cilomilast/albuterol/ipratropium +231.1 mL (p < 0.01)	AUC for increase in FEV₁: cilomilast 15 mg -4.7 mL (p = NS vs placebo); cilomilast/albuterol +88.6 mL (p < 0.01 vs cilomilast); cilomilast/ipratropium +116.4 mL (p < 0.01 vs cilomilast); cilomilast/albuterol/ipratropium +169.5 mL (p < 0.01 vs cilomilast)
Gamble (2003)^[13]	to evaluate effects on airway inflammation of cilomilast 15 mg bid for 12 wk in COPD pts.	change from baseline neutrophil % in induced sputum after 12 wk: no difference	mean change from baseline biopsy numbers of CD8+ cells at 10 wk: cilomilast -185/mm² vs placebo +27.7/mm² (p = 0.001)
			mean change from baseline biopsy numbers of CD68+ cells at 10 wk: cilomilast -21.1/mm² vs placebo +25.3/mm² (p = 0.039)
			mean change from baseline biopsy numbers of epithelial neutrophils at 10 wk: cilomilast +0.9/0.1 mm² vs placebo -0.8/0.1 mm² (p = 0.597)
			mean change from baseline biopsy numbers of subepithelial neutrophils at 10 wk: cilomilast +3.2/mm² vs placebo +18.3/mm² (p = 0.496)
			mean change from baseline FEV₁ at 8 wk: cilomilast +40 mL vs placebo -90 mL (p = 0.02)
			mean change from baseline FEV₁ at 12 wk: cilomilast +10 mL vs placebo -60 mL (p = 0.16)

COPD = chronic obstructive pulmonary disease; FEV₁ = forced expiratory volume in 1 second; FVC = forced vital capacity; PEF = peak expiratory flow; SGRQ = St George's Respiratory Questionnaire

Table 1. Cilomilast Efficacy Trials
Reference	Objective	Results
Reference	Objective	Primary Outcomes	Secondary Outcomes
Rennard (2006)^[10]	to assess the efficacy, safety, and tolerability of cilomilast 15 mg po bid over 24 wk in COPD pts.	mean FEV₁ change from baseline at 24 wk: cilomilast +10 mL vs placebo -70 mL (p < 0.001)	trough FVC change from baseline at 24 wk: 110 mL difference in favor of cilomilast (p = 0.001)
		SGRQ total score averaged over 24 wk: cilomilast improved ~3.6 points vs placebo worsened ~0.5 points (p < 0.001)	pts. exacerbation-free at 24 wk: cilomilast 74% vs placebo 62% (p = 0.008)
			postexercise dyspnea score average over 24 wk: cilomilast -0.17 vs placebo +0.07 (p = 0.029)
			6 min walk distance: no difference
			summary symptom scores: no difference
Compton (2001)^[11]	to assess the safety, efficacy, and dose response of cilomilast 5, 10, and 15 mg bid over 6 wk in COPD pts.	prebronchodilator FEV₁ change from baseline at 6 wk: cilomilast 15 mg +160 mL (p < 0.0001 vs placebo); no improvement with 5 mg or 10 mg vs placebo	mean PEF change from baseline at 6 wk: cilomilast 15 mg +34.1 L/min (p < 0.0001 vs placebo); no improvement with 5 mg or 10 mg vs placebo
		postbronchodilator FEV₁ change from baseline at 6 wk: cilomilast 15 mg +100 mL (p < 0.0096 vs placebo); no improvement with 5 mg or 10 mg vs placebo	mean FVC change from baseline at 6 wk: cilomilast 15 mg +190 mL (p = 0.001 vs placebo); no improvement with 5 mg or 10 mg vs placebo
			SGRQ total score at 6 wk: cilomilast 15 mg improved by 3.9 points (p = NS vs placebo); no improvement with 5 mg or 10 mg vs placebo
			first dose FEV₁ change from baseline at 4 h: cilomilast 15 mg +80 mL (p = 0.0089 vs placebo); no results in 5 mg or 10 mg groups reported
Grootendorst (2003)^[12]	to estimate the difference in first-dose bronchodilation between single-dose cilomilast 15 mg and placebo 8 h after administration and between a single dose of cilomilast 15 mg and cilomilast 15 mg with inhaled bronchodilators (albuterol, ipratropium, albuterol with ipratropium) in COPD pts.	maximum FEV₁ change from baseline at 8 h: cilomilast 15 mg +140 mL vs placebo +152 mL (p = NS); vs cilomilast/albuterol +132.1 mL (p < 0.01); vs cilomilast/ipratropium +148.4 mL (p < 0.01); vs cilomilast/albuterol/ipratropium +231.1 mL (p < 0.01)	AUC for increase in FEV₁: cilomilast 15 mg -4.7 mL (p = NS vs placebo); cilomilast/albuterol +88.6 mL (p < 0.01 vs cilomilast); cilomilast/ipratropium +116.4 mL (p < 0.01 vs cilomilast); cilomilast/albuterol/ipratropium +169.5 mL (p < 0.01 vs cilomilast)
Gamble (2003)^[13]	to evaluate effects on airway inflammation of cilomilast 15 mg bid for 12 wk in COPD pts.	change from baseline neutrophil % in induced sputum after 12 wk: no difference	mean change from baseline biopsy numbers of CD8+ cells at 10 wk: cilomilast -185/mm² vs placebo +27.7/mm² (p = 0.001)
			mean change from baseline biopsy numbers of CD68+ cells at 10 wk: cilomilast -21.1/mm² vs placebo +25.3/mm² (p = 0.039)
			mean change from baseline biopsy numbers of epithelial neutrophils at 10 wk: cilomilast +0.9/0.1 mm² vs placebo -0.8/0.1 mm² (p = 0.597)
			mean change from baseline biopsy numbers of subepithelial neutrophils at 10 wk: cilomilast +3.2/mm² vs placebo +18.3/mm² (p = 0.496)
			mean change from baseline FEV₁ at 8 wk: cilomilast +40 mL vs placebo -90 mL (p = 0.02)
			mean change from baseline FEV₁ at 12 wk: cilomilast +10 mL vs placebo -60 mL (p = 0.16)

COPD = chronic obstructive pulmonary disease; FEV₁ = forced expiratory volume in 1 second; FVC = forced vital capacity; PEF = peak expiratory flow; SGRQ = St George's Respiratory Questionnaire

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