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

NCT ID: NCT01762800

Last Updated: 2016-11-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 407 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-09-30

Brief Summary

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.

Detailed Description

PROTOCOL SUMMARY Rationale Both ADOAIR and tiotropium bromide ( hereinafter tiotropium）are now well established, effective treatments for COPD and are frequently co-prescribed (hereinafter TRIPLE therapy). The addition of ADOAIR to tiotropium improves lung function and quality of life and may further reduce exacerbations. GOLD 2011 thus recommends TRIPLE therapy as the second choice of COPD treatment strategy. However, the criteria for switching from each individual treatment to TRIPLE therapy are not clearly shown so far.

This study will be conducted in Japanese subjects with COPD and will assess whether the GOLD 2011 strategy is effective in medical practice in Japan.

Objective(s) The objective of the study is to assess the control of COPD using a symptom and exacerbation risk based treatment strategy based on GOLD 2011.

Study Design Multicenter, randomized, double-dummy, 24-weeks, observational study Study Endpoints/Assessments Primary

• Proportion of patients who were able to remain on the randomized therapy Secondary
• Proportion of patients who switched to TRIPLE therapy
• Proportion of patients who controlled by TRIPLE therapy
• Proportion of patients controlled by randomized therapy plus TRIPLE therapy
• Time to switching to TRIPLE therapy
• Time to first exacerbation
• Proportion of diagnosed exacerbation confirmed by Daily Record Card
• Proportion of exacerbations detected by Daily Record Card not diagnosed
• CAT score change
• Change in FEV1
• Use of relief medication
• Proportion of patients who decreased treatment from TRIPLE therapy
• Proportion of patients who required additional treatment to TRIPLE therapy
• Proportion of patients who dropped out
• Patients' judgment of treatment efficacy
• Physician's judgment of treatment efficacy

Safety

• Adverse event reporting
• Exacerbations of COPD

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

fluticasone propionate/salmeterol

Randomised treatment at Visit 2

Group Type: EXPERIMENTAL

fluticasone propionate/salmeterol 50/250mcg

Intervention Type: DRUG

Active, 50/250mcg, Twice daily (morning and evening)

tiotropium bromide placebo

Intervention Type: DRUG

Placebo, Once daily(morning)

fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg

Intervention Type: DRUG

Active. The randomized treatment may be switched to TRIPLE therapy when COPD symptoms are uncontrolled or the subject is not satisfied with the randomized treatment at each scheduled or unscheduled visit.

tiotropium bromide

Randomised treatment at Visit 2

Group Type: EXPERIMENTAL

fluticasone propionate/salmeterol placebo

Intervention Type: DRUG

Placebo, Twice daily (morning and evening)

tiotropium bromide 18mcg

Intervention Type: DRUG

Active, 18mcg, Once daily(morning)

fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg

Intervention Type: DRUG

Active. The randomized treatment may be switched to TRIPLE therapy when COPD symptoms are uncontrolled or the subject is not satisfied with the randomized treatment at each scheduled or unscheduled visit.

Interventions

fluticasone propionate/salmeterol 50/250mcg

Active, 50/250mcg, Twice daily (morning and evening)

Intervention Type: DRUG

fluticasone propionate/salmeterol placebo

Placebo, Twice daily (morning and evening)

Intervention Type: DRUG

tiotropium bromide 18mcg

Active, 18mcg, Once daily(morning)

Intervention Type: DRUG

tiotropium bromide placebo

Placebo, Once daily(morning)

Intervention Type: DRUG

fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg

Active. The randomized treatment may be switched to TRIPLE therapy when COPD symptoms are uncontrolled or the subject is not satisfied with the randomized treatment at each scheduled or unscheduled visit.

Intervention Type: DRUG

Other Intervention Names

ADOAIR is a registered trade mark of the GlaxoSmithKline group of companies; TRIPLE therapy

Eligibility 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

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:

1. ADOAIR DISKUS package insert

2. Tiotropium/ HandiHaler package insert

3. Salbutamol package insert

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Fukuoka, , Japan

GSK Investigational Site

Hiroshima, , Japan

GSK Investigational Site

Hiroshima, , Japan

GSK Investigational Site

Hiroshima, , Japan

GSK Investigational Site

Hiroshima, , Japan

GSK Investigational Site

Hokkaido, , Japan

GSK Investigational Site

Hyōgo, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Ibaraki, , Japan

GSK Investigational Site

Kagawa, , Japan

GSK Investigational Site

Kagawa, , Japan

GSK Investigational Site

Kagawa, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Kanagawa, , Japan

GSK Investigational Site

Kochi, , Japan

GSK Investigational Site

Kyoto, , Japan

GSK Investigational Site

Kyoto, , Japan

GSK Investigational Site

Nara, , Japan

GSK Investigational Site

Niigata, , Japan

GSK Investigational Site

Niigata, , Japan

GSK Investigational Site

Niigata, , Japan

GSK Investigational Site

Okinawa, , Japan

GSK Investigational Site

Okinawa, , Japan

GSK Investigational Site

Okinawa, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Osaka, , Japan

GSK Investigational Site

Saga, , Japan

GSK Investigational Site

Shizuoka, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Tokyo, , Japan

GSK Investigational Site

Yamaguchi, , Japan

Countries

Japan

References

Betsuyaku T, Kato M, Fujimoto K, Hagan G, Kobayashi A, Hitosugi H, James M, Jones PW. A study to assess COPD Symptom-based Management and to Optimise treatment Strategy in Japan (COSMOS-J) based on GOLD 2011. Int J Chron Obstruct Pulmon Dis. 2013;8:453-9. doi: 10.2147/COPD.S48298. Epub 2013 Oct 3.

Reference Type: DERIVED

PMID: 24124358 (View on PubMed)

Other Identifiers

116717

Identifier Type: -

Identifier Source: org_study_id