Clareo Health | A 3 Way Cross-over Study Evaluating the Effects of ADOAIR Twice Daily Plus Tiotropium Bromide Once Daily Compared With the Individual Treatments of Japanese Subjects
A 3 Way Cross-over Study Evaluating the Effects of ADOAIR Twice Daily Plus Tiotropium Bromide Once Daily Compared With the Individual Treatments of Japanese Subjects
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
GlaxoSmithKline
Age
40–80
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Male or female aged 40 - 80 years inclusive
Has an established clinical history of COPD (defined as per the GOLD definition)
A signed and dated written informed consent is obtained from the subject prior to study participation
The subject has a post-bronchodilator FEV1 of \>=30% to =\<75% of predicted normal at Visit 1
The subject has a post-bronchodilator FEV1/ FVC ratio \<70% at Visit 1
The subject achieves a score of 1 on the Modified Medical Research Council (mMRC) Dyspnoea Scale at Visit 1
The subject is a current or ex-smoker with a smoking history of \> 10 pack-years (10 pack years is defined as 20 cigarettes per day for 10 years, or 10 cigarettes (or equivalent if subject smoked cigars or a pipe) per day for 20 years). Ex-smokers are required to have stopped smoking for at least 6 months prior to visit 1. Ex-smokers who stopped smoking less than 6 months ago will be defined as current smokers.
QTc \<450 msec at Visit 1; or for patients with Bundle Branch Block QTc should be \<480 msec.
(QTc(F) \<450msec, or \<480 in subjects with right bundle branch block, should be confirmed by the mean of three readings or one reading)
ALT \< 2xULN and bilirubin/ALP \< 1.5xULN (\>35% direct bilirubin)
A female is eligible to enter this study if she is: i)of non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal), ii)of child-bearing potential, but has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study or iii)not a nursing mother
You may not be if
Has had a COPD exacerbation within the 4 weeks prior to Visit 1
Had any changes in COPD medication in the 4 weeks prior to Visit 1
Has plan to change the dosage of Xanthines or to stop receiving it during the study
Has a current medical diagnosis of asthma
Has a medical diagnosis of narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction that in the opinion of the investigator should prevent them from entering the study Note: As with other anticholinergic drugs, subjects with narrow-angle glaucoma, prostatic hyperplasia or bladder neck obstruction should only be entered into the study at the Investigator's discretion
Has known respiratory disorders other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis)
Has undergone lung surgery e.g., lung transplant and/or lung volume reduction
Is currently receiving pulmonary rehabilitation
Had a chest X-ray indicating diagnosis other than COPD that might interfere with the study (chest X-ray to be taken at entry, if subject has not had one or CT image taken within 3 months of Visit 1)
Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as . 12 hours oxygen use per day)
Requires regular treatment with oral, parenteral, or depot corticosteroids or has received 2 or more periods of oral corticosteroids for COPD exacerbation in the last 6 months
Received oral, parenteral, or depot corticosteroids in the 4 weeks prior to Visit 1
Received antibiotic therapy for either a lower respiratory tract infection or for COPD exacerbation within the 4 weeks prior to Visit 1
Has been hospitalized for a COPD exacerbation in the last year
Has serious, uncontrolled disease likely to interfere with the study (e.g. Left Ventricular failure, anaemia, renal or hepatic disease or serious psychological disorders)
Received any other investigational drugs within 4 weeks (or 5 half lives) prior to Visit 1
Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse
Has a known or suspected hypersensitivity to β2-agonists, inhaled steroids, anticholinergic treatments or any components of the formulations (e.g. lactose or milk protein)
Has previously been enrolled and randomized to this study
Are not considered able to tolerate three 2-weeks wash-out periods according to the study schedule with all COPD medications removed apart from rescue use of SALBUTAMOL via MDI (inhaled PRN use).
