Last updated: 07/17/2024 16:51:21
Evaluating the control of COPD symptoms in patients treated with tiotropium bromide 18mcg once daily alone, ADOAIR 50/250mcg twice daily alone or ADOAIR 50/250mcg plus tiotropium bromide 18mcg
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Evaluating the control of COPD symptoms in patients treated with tiotropium bromide 18mcg once daily alone, ADOAIR 50/250mcg twice daily alone or ADOAIR 50/250mcg plus tiotropium bromide 18mcg
Trial description: The purpose of this study is to assess the control of COPD using a symptom and exacerbation risk based treatment strategy based on GOLD 2011. This study is conducted in Japanese subjects with COPD and assess whether the GOLD 2011 strategy is effective in medical practice in Japan.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Percentage of participants who were able to remain on the randomized treatment
Timeframe: 24 weeks
Secondary outcomes:
Percentage of participants who switched to TRIPLE therapy
Timeframe: 24 weeks
Percentage of participants managed by TRIPLE therapy
Timeframe: 24 weeks
Continuation percentage of participants managed by randomized treatment plus TRIPLE therapy
Timeframe: 24 weeks
Time to first switching to TRIPLE therapy
Timeframe: 24 weeks
Time to first exacerbation by physician's diagnosis
Timeframe: 24 weeks
Time to first exacerbation by EXAcerbations of Chronic pulmonary disease Tool (EXACT)
Timeframe: 24 weeks
EXACT total score.
Timeframe: Baseline and up to 24 weeks
EXACT Respiratory Symptoms (E-RS) total score
Timeframe: Baseline and up to 24 weeks
E-RS subscale score
Timeframe: 24 weeks
Comparison of number of exacerbations between two detection methods: EXACT and physician diagnosis
Timeframe: 24 weeks
Chronic Obstructive Pulmonary Disease (COPD) Assessment Test (CAT) total score
Timeframe: 24 weeks
Change from Baseline in CAT total score
Timeframe: Baseline and up to 24 weeks
Forced expiratory volume in one second (FEV1)
Timeframe: Up to 24 weeks
Change from Baseline in FEV1
Timeframe: Baseline (Visit 2) and up to 24 weeks
Percentage of participants who used relief medication (salbutamol)
Timeframe: 24 weeks
Percentage of participants who stepped down from TRIPLE therapy to initial randomized treatment
Timeframe: 24 weeks
Percentage of participants who required additional treatment to TRIPLE therapy
Timeframe: 24 weeks
Percentage of participants who dropped out
Timeframe: 24 weeks
Number of participants in each treatment efficacy grade evaluated by participants
Timeframe: Up to 24 weeks
Number of participants in each treatment efficacy grade evaluated by physician
Timeframe: 24 weeks
Interventions:
Drug: fluticasone propionate/salmeterol 50/250mcg
Drug: fluticasone propionate/salmeterol placebo
Drug: tiotropium bromide 18mcg
Drug: tiotropium bromide placebo
Drug: fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg
Enrollment:
407
Observational study model:
Not applicable
Primary completion date:
2015-04-09
Time perspective:
Not applicable
Clinical publications:
Tomoko Betsuyaku, Motokazu Kato, Keisaku Fujimoto, Akihiro Kobayashi, Tomoyuki Hayamizu, Hideki Hitosugi, Gerald Hagan, Mark H James, Paul W Jones. A randomized trial of symptom-based management in Japanese patients with COPD. Int J Chron Obstruct Pulmon Dis. 2018;13:2409—2423.
DOI: 10.2147/COPD.S152723
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
fluticasone propionate, fluticasone propionate/salmeterol, salmeterol
Collaborators
Not applicable
Study date(s)
February 2013 to September 2015
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40 - 80 years
Accepts healthy volunteers
No
- 1. Male or female aged 40 - 80 years inclusive
- 2. Has an established clinical history of COPD (defined as per the GOLD definition)
- 1.Has a predominant asthma (comorbid asthma is not an exclusion criteria)
- 2.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
Inclusion and exclusion criteria
Inclusion criteria:
- 1. Male or female aged 40
- 80 years inclusive 2. Has an established clinical history of COPD (defined as per the GOLD definition) 3. The subject achieves a grade of ≥1 on mMRC at Visit 1 4. A signed and dated written informed consent is obtained from the subject prior to study participation 5. The subject has a post-bronchodilator FEV1 of ≥ 30% to ≤ 80% of predicted normal 6. The subject has a post-bronchodilator FEV1 / FVC ratio < 70% 7. The subject is a current or ex-smoker with a smoking history of > 10 pack-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. 8. QTc < 450 msec at Visit 1; or for patients with bundle branch block QTc should be < 480 msec. (QTc(F) < 450 msec, or < 480 msec in subjects with right bundle branch block, should be confirmed by the mean of three readings or one reading) 9. ALT < 2 x ULN and bilirubin/ALP ≤ 1.5 x ULN (> 35% direct bilirubin) 10. 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), or 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 iii) not a nursing mother
Exclusion criteria:
- 1.Has a predominant asthma (comorbid asthma is not an exclusion criteria) 2.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 3.Has known respiratory disorders other than COPD (e.g. lung cancer, sarcoidosis, tuberculosis or lung fibrosis) 4.Has undergone lung surgery e.g., lung transplant and/or lung volume reduction 5.Had a chest X-ray indicating diagnosis other than COPD that might interfere with the study (chest X-ray to be taken at Visit 1, if subject has not had one and/or CT image taken within 3 months of Visit 1) 6.Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as ≥ 12 hours oxygen use per day) 7.Has plan to start or to change the pulmonary rehabilitation program during the study period 8.Requires regular treatment with oral, parenteral, or depot corticosteroids 9.Has serious, uncontrolled disease likely to interfere with the study (e.g. Left Ventricular failure, anaemia, renal or hepatic disease or serious psychological disorders) 10.Received any other investigational drugs within 4 weeks (or 5 half lives) prior to Visit 1 11.Has, in the opinion of the investigator, evidence of alcohol, drug or solvent abuse 12.Has a known or suspected hypersensitivity to β2-agonists, steroids, anticholinergic treatments or any components of the formulations 13.Has previously been enrolled to this study and investigational drugs has been administered 14.Is not eligible to participate this study in the opinion of the investigator/subinvestigator The investigator must refer to the following document(s) for detailed information regarding warnings, precautions, contraindications, adverse events, and other significant data pertaining to the investigational product(s) being used in this study: a.ADOAIR DISKUS package insert b.Tiotropium/ HandiHaler package insert c.Salbutamol package insert
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2015-04-09
Actual study completion date
2015-04-09
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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