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

Sponsor

Mundipharma Research Limited (Industry)

Overall Status

Completed

CT.gov ID

NCT01946620

Collaborator

(none)

1,767

Enrollment

Locations

Arms

Duration (Months)

117.8

Patients Per Site

3.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Obstructive Pulmonary Disease	Drug: Flutiform Drug: Formoterol	Phase 3

Detailed 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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1767 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Primary Purpose:

Treatment

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).

Study Start Date :

Oct 1, 2013

Actual Primary Completion Date :

Apr 1, 2016

Actual Study Completion Date :

May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Flutiform 250/10 micrograms Flutiform 250/10 µg (2 puffs twice daily)	Drug: Flutiform
Experimental: Flutiform 125/5 micrograms Flutiform 125/5 µg (2 puffs twice daily)	Drug: Flutiform
Active Comparator: Formoterol 12 micrograms Formoterol 12 µg 1 puff twice daily	Drug: Formoterol

Arm

Intervention/Treatment

Experimental: Flutiform 250/10 micrograms

Flutiform 250/10 µg (2 puffs twice daily)

Drug: Flutiform

Experimental: Flutiform 125/5 micrograms

Flutiform 125/5 µg (2 puffs twice daily)

Drug: Flutiform

Active Comparator: Formoterol 12 micrograms

Formoterol 12 µg 1 puff twice daily

Drug: Formoterol

Outcome Measures

Primary Outcome Measures

Annual rate of moderate and severe COPD exacerbations [52 weeks]
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

Secondary Outcome Measures

Annual rate of moderate and severe COPD exacerbations [52 Weeks]
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)
Efficacy confirmed by lack of exacerbations, lung function and safety by collection of adverse events in all patients throughout the study. [52 Weeks]
To compare flutiform (at each dose) with formoterol 12 µg (1 puff BID) for the secondary efficacy, and safety endpoints.

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion:

Male or Female subjects aged ≥ 40 years at screening visit:
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.
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
Smoking history of ≥10 packs per year.
Diagnosis of COPD
History of ≥ moderate or severe COPD exacerbations in previous year.
Willing and able to replace current COPD therapy with study medication.
Able to demonstrate correct use of a pMDI without a spacer.
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 (see section 10)
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) at least 12 hours daily or mechanical ventilation
Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities reflective of active disease 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 or contraindication to any of the study drugs or excipients
Received an investigational drug within 30 days of the screening visit (12 weeks if an oral or injectable steroid).

Contacts and Locations

Locations

	City	Country
1	Sofia	Bulgaria
2	Hamburg	Germany
3	Budapest	Hungary
4	Gyeonggido	Korea, Republic of
5	Riga	Latvia
6	Vilnius	Lithuania
7	Skopje	Macedonia, The Former Yugoslav Republic of
8	Lubuskie	Poland
9	Bacau	Romania
10	Moscow	Russian Federation
11	Presov	Slovakia
12	Cape Town	South Africa
13	Barcelona	Spain
14	Kyiv	Ukraine
15	London	United Kingdom