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Flutiform® Compared With Seretide® in the Treatment of COPD

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

Flutiform 500/20 µg BID

Flutiform 250/10 µg BID

Seretide Accuhaler 50/500 µg BID

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, FEV1 ≤ 50%

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion:

Male or Female subjects aged ≥ 40 years at screening visit.
Diagnosis of COPD
Willing and able to replace current COPD therapy with study medication.
Able to demonstrate correct use of a pMDI with or without a spacer and Accuhaler.
Willing and able to attend all study visits and complete study assessments.
Able to provide signed informed consent.

Exclusion:

Ongoing moderate or severe exacerbation of COPD in the 2 weeks before screening.
Current diagnosis of asthma.
Documented evidence of α1-antitrypsin deficiency as the underlying cause of COPD.
Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans.
Previous lung resection.
Use of long-term oxygen therapy (LTOT) or mechanical ventilation. Note: LTOT is defined as >15 hours use per day
Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities not believed to be due to COPD.
Evidence of uncontrolled cardiovascular disease.
Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease.
Current malignancy or a previous history of cancer which has been in remission for < 5 years (basal cell or squamous cell carcinoma of the skin which has been resected is not excluded).
Clinically significant sleep apnoea requiring use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
Participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study.
Known or suspected history of drug or alcohol abuse in the last 2 years.
Requiring treatment with any of the prohibited concomitant medications.
Known or suspected hypersensitivity to study drug or excipients.
Received an investigational drug within 30 days of the screening visit (12 weeks if an oral or injectable steroid).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Arm Label

Flutiform 500/20 µg BID

Flutiform 250/10 µg BID

Seretide Accuhaler 50/500 µg BID

Arm Description

Flutiform 250/10 (2 puffs BID)

Flutiform 125/5 (2 puffs BID)

Seretide Accuhaler 50/500 (BID)

Outcomes

Primary Outcome Measures

Average pre-dose FEV1

Secondary Outcome Measures

Average 1 hour Post dose FEV1, FVC, FEV6

Full Information

NCT ID

NCT02195375

First Posted

July 16, 2014

Last Updated

March 27, 2017

Sponsor

Mundipharma Research Limited

1. Study Identification

Unique Protocol Identification Number

NCT02195375

Brief Title

Flutiform® Compared With Seretide® in the Treatment of COPD

Official Title

A Randomised Double-blind, Double-dummy Parallel Group Study to Compare the Efficacy and Safety of Fluticasone Propionate / Formoterol Fumarate (Flutiform®) 500/20 µg BID and 250/10 µg BID Versus Salmeterol / Fluticasone (Seretide®) 50/500 µg BID in Subjects With Chronic Obstructive Pulmonary Disease (COPD)

Study Type

Interventional

2. Study Status

Record Verification Date

March 2017

Overall Recruitment Status

Completed

Study Start Date

September 2014 (undefined)

Primary Completion Date

May 2016 (Actual)

Study Completion Date

May 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mundipharma Research Limited

4. Oversight

5. Study Description

Brief Summary

The purpose of this study is to investigate whether flutiform® is effective and safe in the treatment of chronic obstructive pulmonary disease (COPD).

Detailed Description

A multi-centre, randomised, double-blind, double dummy, active-controlled, parallel-group study in male and female subjects conducted to assess the efficacy and safety of flutiform in the treatment of COPD. Subjects will be randomised to one of three treatment groups in a 1:1:1 ratio. Throughout the study subjects will be assessed on a mixture of symptom based and lung function measurements to monitor their progress in the study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease, FEV1 ≤ 50%

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

923 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Flutiform 500/20 µg BID

Arm Type

Experimental

Arm Description

Flutiform 250/10 (2 puffs BID)

Arm Title

Flutiform 250/10 µg BID

Arm Type

Experimental

Arm Description

Flutiform 125/5 (2 puffs BID)

Arm Title

Seretide Accuhaler 50/500 µg BID

Arm Type

Active Comparator

Arm Description

Seretide Accuhaler 50/500 (BID)

Intervention Type

Drug

Intervention Name(s)

Flutiform 500/20 µg BID

Intervention Type

Drug

Intervention Name(s)

Flutiform 250/10 µg BID

Intervention Type

Drug

Intervention Name(s)

Seretide Accuhaler 50/500 µg BID

Primary Outcome Measure Information:

Title

Average pre-dose FEV1

Time Frame

26 weeks

Secondary Outcome Measure Information:

Title

Average 1 hour Post dose FEV1, FVC, FEV6

Time Frame

26 Weeks

Other Pre-specified Outcome Measures:

Title

Moderate and Severe COPD Exacerbations

Time Frame

26 weeks

Title

COPD Assessment Test

Time Frame

Change from baseline to week 8, week 14, week 26

Title

Average capacity of daily living during the morning score

Time Frame

26 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion: Male or Female subjects aged ≥ 40 years at screening visit. Diagnosis of COPD Willing and able to replace current COPD therapy with study medication. Able to demonstrate correct use of a pMDI with or without a spacer and Accuhaler. Willing and able to attend all study visits and complete study assessments. Able to provide signed informed consent. Exclusion: Ongoing moderate or severe exacerbation of COPD in the 2 weeks before screening. Current diagnosis of asthma. Documented evidence of α1-antitrypsin deficiency as the underlying cause of COPD. Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans. Previous lung resection. Use of long-term oxygen therapy (LTOT) or mechanical ventilation. Note: LTOT is defined as >15 hours use per day Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities not believed to be due to COPD. Evidence of uncontrolled cardiovascular disease. Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease. Current malignancy or a previous history of cancer which has been in remission for < 5 years (basal cell or squamous cell carcinoma of the skin which has been resected is not excluded). Clinically significant sleep apnoea requiring use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device. Participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study. Known or suspected history of drug or alcohol abuse in the last 2 years. Requiring treatment with any of the prohibited concomitant medications. Known or suspected hypersensitivity to study drug or excipients. Received an investigational drug within 30 days of the screening visit (12 weeks if an oral or injectable steroid).

Facility Information:

City

Fitzroy

Country

Australia

City

Beijing

Country

China

City

Seoul

Country

Korea, Republic of

City

Wellington

Country

New Zealand

City

Taipei

Country

Taiwan

12. IPD Sharing Statement

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Flutiform® Compared With Seretide® in the Treatment of COPD

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