A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD

Chronic Obstructive Pulmonary Disease Clinical Trial

Official title:

A Randomised, Double-blind, Double Dummy, Parallel Group Study Comparing Fluticasone Propionate / Formoterol Fumarate (Flutiform®) 250/10 µg (2 Puffs BID) and Flutiform® 125/5 µg (2 Puffs BID) Versus Formoterol Fumarate Dihydrate (Atimos®) 12 µg (1 Puff BID) in Subjects With Chronic Obstructive Pulmonary Disease (COPD).

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01946620
• Other study ID #: FLT3509
• Secondary ID: 2012-004162-17
• Status: Completed
• Phase: Phase 3
• Start date: October 2013
• Est. completion date: May 2016

Study information

• Verified date: October 2018
• Source: Mundipharma Research Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.

Description:

This study is a multi-centre, randomised, double-blind, active-controlled, parallel-group study, in male and female subjects who will be assigned into 1 of 3 treatment groups based on 1:1:1 ratio. Following a 2 week run-in phase all subjects will receive treatment for 1 year (52 weeks) followed by a final follow up 2 weeks after their last visit, during this time subjects will be required to attend 10 clinic visits while the final follow up can be completed by telephone. Throughout the study subjects will be assessed on a mixture of symptom based measurements as well as lung function tests to monitor their progress in the study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1767
• Est. completion date: May 2016
• Est. primary completion date: April 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:

1. Female subjects of child bearing potential (less than 1 year post-menopausal) must have a negative urine pregnancy test prior to first dose of study medication, be non-lactating, and willing to use adequate and highly effective methods of birth control throughout the study such as sterilisation, implants, injectables, combined oral contraceptives, some intra-uterine devices, sexual abstinence or vasectomised partner.

2. Male subjects with a partner of child bearing potential must be willing to use adequate and highly effective methods of birth control throughout the study

2. Smoking history of =10 packs per year.

3. Diagnosis of COPD

4. History of = moderate or severe COPD exacerbations in previous year.

5. Willing and able to replace current COPD therapy with study medication.

6. Able to demonstrate correct use of a pMDI without a spacer.

7. Willing and able to attend all study visits and complete study assessments.

8. Able to provide signed informed consent.

Exclusion:

1. Ongoing moderate or severe exacerbation of COPD (see section 10)

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) at least 12 hours daily or mechanical ventilation

7. Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities reflective of active disease 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 or contraindication to any of the study drugs 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

• Formoterol

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Mundipharma Research Limited

Countries where clinical trial is conducted

Bulgaria,  Germany,  Hungary,  Korea, Republic of,  Latvia,  Lithuania,  Macedonia, The Former Yugoslav Republic of,  Poland,  Romania,  Russian Federation,  Slovakia,  South Africa,  Spain,  Ukraine,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Annual rate of moderate and severe COPD exacerbations	To show superiority in the efficacy of flutiform 250/10 µg (2 puffs BID) compared with formoterol 12 µg (1 puff BID) based on the annual rate of moderate and severe COPD exacerbations	52 weeks
Secondary	Annual rate of moderate and severe COPD exacerbations	To show superiority in the efficacy of flutiform 125/5 µg (2 puffs BID) compared with formoterol 12 µg (1 puff BID) based on the annual rate of moderate and severe COPD exacerbations. (Different dose to Primary Outcome)	52 Weeks
Secondary	Efficacy confirmed by lack of exacerbations, lung function and safety by collection of adverse events in all patients throughout the study.	To compare flutiform (at each dose) with formoterol 12 µg (1 puff BID) for the secondary efficacy, and safety endpoints.	52 Weeks

External Links

•   Link to Results