Supplementary Table 1. Inclusion criteria
Inclusion criteria
1) Men and women who at time of informed consent were 40 years or older
2) Diagnosed with COPD by respiratory specialist doctor
3) Patients not receiving regular COPD treatment
4) Outpatient smoking history of 10 pack years or more
5) Percentage of the predicted value of FEV1 of 80% or less*
6) FEV1/FVC after bronchodilator inhalation of less than 70%
7) Result of pre examination by the doctor indicated the patient was eligible
8) Patients who signed informed consent forms
FEV1, forced expiratory volume in 1 second; FVC, forced vital capacity; COPD,
chronic obstructive pulmonary disease.
*Prediction formula of FEV1: (male): Predicted value of FEV1 (L) = 0.036 × height (cm)
− 0.028 × age − 1.178; (female): Predicted value of FEV1 (L) = 0.022 × height (cm) −
0.022 × age − 0.005.
Supplementary Table 2. Exclusion criteria
Exclusion criteria
1) Persons with a history of hypersensitivity to any ingredient in each standard therapy
2) Patients with a disease contraindicated in the package insert of each standard therapy
3) Abnormal laboratory values or a clinical problem was observed
4) Alcohol or drug abusers
5) Patients unable to undergo non-smoking guidance
6) Patients with bronchial asthma, cystic fibrosis, bronchiectasis, interstitial lung disease,
pulmonary thrombosis and pulmonary embolism
7) Persons with a history of thoracotomy with lung resection
8) Those with planned lung volume reduction surgery or lung transplantation
9) Those who could not perform pulmonary function tests
10) Persons who had regularly used inhaled steroids or long-acting bronchodilators
before the start of the survey
11) Those who were taking the study drug, or who took part in the clinical trial or other
clinical trials within 2 months before obtaining informed consent
12) Persons pregnant or suspected of being pregnant, or who were breastfeeding
13) Others determined to be inappropriate by the examining doctor
Supplementary Table 3. Drugs administered in this study
Product name
General name
Route of
administration
Pharmaceutical company
Pharmaceutical
company country
Long-acting bronchodilator agents
Serevent
Salmeterol xinafoate
Inhalation
GlaxoSmithKline K.K.
Hokunalin Tape
Tulobuterol
Transdermal
Abbott Japan Co., Ltd.
UK (GlaxoSmithKline
plc)
USA (Abbott
Laboratories)
Theophyllines
Uniphyl LA
Theophylline
Oral
Otsuka Pharmaceutical Co.,
Ltd.
Japan
Inhalation
GlaxoSmithKline K.K
UK (GlaxoSmithKline
plc)
Japan
Short-acting bronchodilator agents
Sultanol
Salbutamol sulfate
Meptin
Procaterol hydrochloride
Inhalation
Clickhaler
hydrate
Inhaled corticosteroid/long-acting bronchodilator agents
Advair
Fluticasone
Inhalation
propionate/Salmeterol
xinafoate
Symbicort
Budesonide/Formoterol
Inhalation
fumarate hydrate
Mucolytic agents
Mucodyne
L-carbocisteine
Oral
Methista
L-carbocisteine
Oral
Otsuka Pharmaceutical Co.,
Ltd.
GlaxoSmithKline K.K
UK (GlaxoSmithKline
plc)
AstraZeneca K.K
UK (AstraZeneca plc)
Kyorin Pharmaceutical Co.,
Ltd.
Towa Pharmaceutical Co.,
Ltd.
Japan
Japan
Short-acting muscarinic antagonist
Tersigan
Oxitropium bromide
Inhalation
Boehringer Ingelheim Japan,
Inc.
Germany (Boehringer
Ingelheim GmbH)
Smoking cessation agent
Champix
Varenicline tartrate
Oral
Pfizer Japan Inc.
USA (Pfizer Inc.)
Supplementary Table 4. Analysis of the ITT group that reached the pharmacologic
maintenance phase.
Stage of smoking behavior in
past smokers
Visit 1 at
baseline
0
0
1
12
Visit 2
at Week
8
0
0
1
11
Visit 3
at Week
16
0
0
3
6
Visit 4
at Week
24
0
0
1
3
Visit 5
at Week
36
0
0
3
0
Visit 6
at Week
48
0
1
1
3
Precontemplation (smoking)
Contemplation (smoking)
Preparation (smoking)
Action (under smoking
cessation)
Maintenance
(under smoking cessation)
Unknown
Stage of smoking behavior in
current smokers
26
27
30
31
32
28
0
Visit 1 at
baseline
2
2
6
0
0
Visit 2
at Week
8
2
1
2
5
0
Visit 3
at Week
16
1
2
2
3
4
Visit 4
at Week
24
0
1
0
4
4
Visit 5
at Week
36
0
0
0
2
6
Visit 6
at Week
48
0
1
1
2
Precontemplation (smoking)
Contemplation (smoking)
Preparation (smoking)
Action (under smoking
cessation)
Maintenance
(under smoking cessation)
Unknown
0
0
2
3
5
4
0
0
0
2
3
2