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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT01946620
• Date of registration: 10/09/2013
• Prospective Registration: Yes
• Primary sponsor: Mundipharma Research Limited
• Public title: A Study to Show That Flutiform is Well Tolerated and Effective in the Treatment of COPD
• Scientific 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).
• Date of first enrolment: October 2013
• Target sample size: 1767
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01946620
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

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

Key inclusion & exclusion criteria

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).



Age minimum: 40 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Obstructive Pulmonary Disease

Intervention(s)

Drug: Formoterol

Drug: Flutiform

Primary Outcome(s)

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

Secondary Outcome(s)

Annual rate of moderate and severe COPD exacerbations [Time Frame: 52 Weeks]

Efficacy confirmed by lack of exacerbations, lung function and safety by collection of adverse events in all patients throughout the study. [Time Frame: 52 Weeks]

Secondary ID(s)

2012-004162-17

FLT3509

Source(s) of Monetary Support

Please refer to primary and secondary sponsors