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

NCT01762800 | Completed Phase 4 Results

• 1 other identifier: 116717
• Study Type: interventional
• Target: 407
• Locations: 1 country
• Sites: 39

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.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants Who Were Able to Remain on the Randomized Treatment

  The randomized treatment could be switched to TRIPLE therapy in the case that chronic obstructive pulmonary disease (COPD) is not controlled by the randomized treatment. Participants on TRIPLE therapy received SAL/FLU 50/250 µg BID plus TIO 18 µg QD together. The percentage of participants who were able to remain on the randomized treatment was calculated by the following formula: 100 minus percentage of participants who switched over to TRIPLE therapy.

  24 weeks

Secondary Outcomes (20)

• Percentage of Participants Who Switched to TRIPLE Therapy

  24 weeks

• Percentage of Participants Managed by TRIPLE Therapy

  24 weeks

• Continuation Percentage of Participants Managed by Randomized Treatment Plus TRIPLE Therapy

  24 weeks

• Time to First Switching to TRIPLE Therapy

  24 weeks

• Time to First Exacerbation by Physician's Diagnosis

  24 weeks

Study Arms (2)

fluticasone propionate/salmeterol

EXPERIMENTAL

Randomised treatment at Visit 2

Drug: fluticasone propionate/salmeterol 50/250mcg; Drug: tiotropium bromide placebo; Drug: fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg

tiotropium bromide

EXPERIMENTAL

Randomised treatment at Visit 2

Drug: fluticasone propionate/salmeterol placebo; Drug: tiotropium bromide 18mcg; Drug: fluticasone propionate/salmeterol 50/250mcg and tiotropium 18mcg

Interventions

fluticasone propionate/salmeterol 50/250mcg DRUG

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

Also known as: ADOAIR is a registered trade mark of the GlaxoSmithKline group of companies

fluticasone propionate/salmeterol

fluticasone propionate/salmeterol placebo DRUG

Placebo, Twice daily (morning and evening)

tiotropium bromide

tiotropium bromide 18mcg DRUG

Active, 18mcg, Once daily(morning)

tiotropium bromide

tiotropium bromide placebo DRUG

Placebo, Once daily(morning)

fluticasone propionate/salmeterol

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

Also known as: TRIPLE therapy

fluticasone propionate/salmeterol; tiotropium bromide

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged 40 - 80 years inclusive
• Has an established clinical history of COPD (defined as per the GOLD definition)
• The subject achieves a grade of ≥1 on mMRC at Visit 1
• 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 ≤ 80% of predicted normal
• The subject has a post-bronchodilator FEV1 / FVC ratio \< 70%
• 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.
• 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

You may not qualify if:

• 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
• 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)
• Requires regular (daily) or long term oxygen therapy (LTOT). (LTOT is defined as ≥ 12 hours oxygen use per day)
• Has plan to start or to change the pulmonary rehabilitation program during the study period
• Requires regular treatment with oral, parenteral, or depot corticosteroids
• 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, steroids, anticholinergic treatments or any components of the formulations
• Has previously been enrolled to this study and investigational drugs has been administered
• 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:
• ADOAIR DISKUS package insert

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (39)

GSK Investigational Site

Fukuoka, 814-0180, Japan

Location

GSK Investigational Site

Fukuoka, 816-0813, Japan

Location

GSK Investigational Site

Hiroshima, 720-0001, Japan

Location

GSK Investigational Site

Hiroshima, 734-8530, Japan

Location

GSK Investigational Site

Hiroshima, 737-0023, Japan

Location

GSK Investigational Site

Hiroshima, 737-0811, Japan

Location

GSK Investigational Site

Hokkaido, 070-8644, Japan

Location

GSK Investigational Site

Hyōgo, 670-0849, Japan

Location

GSK Investigational Site

Ibaraki, 300-0053, Japan

Location

GSK Investigational Site

Ibaraki, 302-0022, Japan

Location

GSK Investigational Site

Ibaraki, 309-1793, Japan

Location

GSK Investigational Site

Ibaraki, 311-3193, Japan

Location

GSK Investigational Site

Ibaraki, 319-1113, Japan

Location

GSK Investigational Site

Kagawa, 760-0018, Japan

Location

GSK Investigational Site

Kagawa, 760-8538, Japan

Location

GSK Investigational Site

Kagawa, 761-8073, Japan

Location

GSK Investigational Site

Kanagawa, 233-0013, Japan

Location

GSK Investigational Site

Kanagawa, 253-0083, Japan

Location

GSK Investigational Site

Kochi, 780-0901, Japan

Location

GSK Investigational Site

Kyoto, 602-8026, Japan

Location

GSK Investigational Site

Kyoto, 610-0113, Japan

Location

GSK Investigational Site

Nara, 630-0293, Japan

Location

GSK Investigational Site

Niigata, 950-1197, Japan

Location

GSK Investigational Site

Niigata, 950-2085, Japan

Location

GSK Investigational Site

Niigata, 950-8725, Japan

Location

GSK Investigational Site

Okinawa, 901-2132, Japan

Location

GSK Investigational Site

Okinawa, 904-2143, Japan

Location

GSK Investigational Site

Okinawa, 904-2293, Japan

Location

GSK Investigational Site

Osaka, 530-0001, Japan

Location

GSK Investigational Site

Osaka, 559-0011, Japan

Location

GSK Investigational Site

Osaka, 560-0005, Japan

Location

GSK Investigational Site

Osaka, 560-8552, Japan

Location

GSK Investigational Site

Saga, 840-8571, Japan

Location

GSK Investigational Site

Shizuoka, 434-8511, Japan

Location

GSK Investigational Site

Tokyo, 103-0027, Japan

Location

GSK Investigational Site

Tokyo, 103-0028, Japan

Location

GSK Investigational Site

Tokyo, 158-0083, Japan

Location

GSK Investigational Site

Tokyo, 187-8510, Japan

Location

GSK Investigational Site

Yamaguchi, 755-0241, Japan

Location

Related Publications (1)

• 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.

  PMID: 24124358 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Fluticasone; Salmeterol Xinafoate; Tiotropium Bromide

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Androstadienes; Androstenes; Androstanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Albuterol; Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 6, 2012
• First Posted: January 8, 2013
• Study Start: February 1, 2013
• Primary Completion: September 1, 2015
• Study Completion: September 1, 2015
• Last Updated: November 10, 2016
• Results First Posted: November 10, 2016

Record last verified: 2016-08

Locations

JP (39)