Flutiform® Compared With Seretide® in the Treatment of COPD

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)

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

Study Overview

• Status: Completed
• Conditions: Chronic Obstructive Pulmonary Disease
• Intervention / Treatment: Drug: Flutiform 500/20 µg BID; Drug: Flutiform 250/10 µg BID; Drug: Seretide Accuhaler 50/500 µg BID

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.

• Study Type: Interventional
• Enrollment (Actual): 923
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Australia
  • Fitzroy, Australia
• China
  • Beijing, China
• Korea, Republic of
  • Seoul, Korea, Republic of
• New Zealand
  • Wellington, New Zealand
• Taiwan
  • Taipei, Taiwan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 36 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion:

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

Exclusion:

1. Ongoing moderate or severe exacerbation of COPD in the 2 weeks before screening.
2. Current diagnosis of asthma.
3. Documented evidence of α1-antitrypsin deficiency as the underlying cause of COPD.
4. Other active respiratory disease such as active tuberculosis, lung cancer, bronchiectasis, sarcoidosis, lung fibrosis, pulmonary hypertension, interstitial lung disease, cystic fibrosis, bronchiolitis obliterans.
5. Previous lung resection.
6. Use of long-term oxygen therapy (LTOT) or mechanical ventilation. Note: LTOT is defined as >15 hours use per day
7. Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities not believed to be due to COPD.
8. Evidence of uncontrolled cardiovascular disease.
9. Evidence of clinically significant renal, hepatic, gastrointestinal, or psychiatric disease.
10. 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).
11. Clinically significant sleep apnoea requiring use of continuous positive airway pressure (CPAP) device or non-invasive positive pressure ventilation (NIPPV) device.
12. Participation in the acute phase of a pulmonary rehabilitation programme within 4 weeks prior to screening or during the study.
13. Known or suspected history of drug or alcohol abuse in the last 2 years.
14. Requiring treatment with any of the prohibited concomitant medications.
15. Known or suspected hypersensitivity to study drug or excipients.
16. Received an investigational drug within 30 days of the screening visit (12 weeks if an oral or injectable steroid).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Flutiform 500/20 µg BID; Flutiform 250/10 (2 puffs BID)	Drug: Flutiform 500/20 µg BID
Experimental: Flutiform 250/10 µg BID; Flutiform 125/5 (2 puffs BID)	Drug: Flutiform 250/10 µg BID
Active Comparator: Seretide Accuhaler 50/500 µg BID; Seretide Accuhaler 50/500 (BID)	Drug: Seretide Accuhaler 50/500 µg BID

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Average pre-dose FEV1	26 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Average 1 hour Post dose FEV1, FVC, FEV6	26 Weeks

Other Outcome Measures

Outcome Measure	Time Frame
Moderate and Severe COPD Exacerbations	26 weeks
COPD Assessment Test	Change from baseline to week 8, week 14, week 26
Average capacity of daily living during the morning score	26 weeks

Collaborators and Investigators

• Sponsor: Mundipharma Research Limited

Study record dates

Study Major Dates

• Study Start: September 1, 2014
• Primary Completion (Actual): May 1, 2016
• Study Completion (Actual): May 1, 2016

Study Registration Dates

• First Submitted: July 16, 2014
• First Submitted That Met QC Criteria: July 17, 2014
• First Posted (Estimate): July 21, 2014

Study Record Updates

• Last Update Posted (Actual): March 28, 2017
• Last Update Submitted That Met QC Criteria: March 27, 2017
• Last Verified: March 1, 2017

More Information

Terms related to this study

• Keywords: Chronic Obstructive Pulmonary Disease; FEV1 ≤ 50%
• Additional Relevant MeSH Terms: Respiratory Tract Diseases; Lung Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; Physiological Effects of Drugs; Autonomic Agents; Peripheral Nervous System Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Bronchodilator Agents; Anti-Asthmatic Agents; Respiratory System Agents; Sympathomimetics; Fluticasone-Salmeterol Drug Combination
• Other Study ID Numbers: FLT3510