Flutiform® Compared With Seretide® in the Treatment of COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02195375
• Other study ID #: FLT3510
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: July 16, 2014
• Last updated: March 27, 2017
• Start date: September 2014
• Est. completion date: May 2016

Study information

• Verified date: March 2017
• Source: Mundipharma Research Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 923
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years and older

Eligibility

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 a1-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).

Related Conditions & MeSH terms

• Chronic Obstructive Pulmonary Disease
• Lung Diseases
• Lung Diseases, Obstructive
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Flutiform 500/20 µg BID

• Flutiform 250/10 µg BID

• Seretide Accuhaler 50/500 µg BID

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research Limited

Countries where clinical trial is conducted

Australia,  China,  Korea, Republic of,  New Zealand,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Moderate and Severe COPD Exacerbations		26 weeks
Other	COPD Assessment Test		Change from baseline to week 8, week 14, week 26
Other	Average capacity of daily living during the morning score		26 weeks
Primary	Average pre-dose FEV1		26 weeks
Secondary	Average 1 hour Post dose FEV1, FVC, FEV6		26 Weeks