Trial Review

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT02195375




Registration number
NCT02195375
Ethics application status
Date submitted
16/07/2014
Date registered
21/07/2014
Date last updated
28/03/2017

Titles & IDs
Public title
Flutiform® Compared With Seretide® in the Treatment of COPD
Scientific 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)
Secondary ID [1] 0 0
FLT3510
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Chronic Obstructive Pulmonary Disease 0 0
Condition category
Condition code
Respiratory 0 0 0 0
Chronic obstructive pulmonary disease

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Flutiform 500/20 µg BID
Treatment: Drugs - Flutiform 250/10 µg BID
Treatment: Drugs - Seretide Accuhaler 50/500 µg BID

Experimental: Flutiform 500/20 µg BID - Flutiform 250/10 (2 puffs BID)

Experimental: Flutiform 250/10 µg BID - Flutiform 125/5 (2 puffs BID)

Active Comparator: Seretide Accuhaler 50/500 µg BID - Seretide Accuhaler 50/500 (BID)


Treatment: Drugs: Flutiform 500/20 µg BID


Treatment: Drugs: Flutiform 250/10 µg BID


Treatment: Drugs: Seretide Accuhaler 50/500 µg BID
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Average pre-dose FEV1
Timepoint [1] 0 0
26 weeks
Secondary outcome [1] 0 0
Average 1 hour Post dose FEV1, FVC, FEV6
Timepoint [1] 0 0
26 Weeks

Eligibility
Key inclusion criteria
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.
Minimum age
40 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
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).

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2/Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2014
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/05/2016
Sample size
Target
Accrual to date
Final
923
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
- Fitzroy
Recruitment postcode(s) [1] 0 0
- Fitzroy
Recruitment outside Australia
Country [1] 0 0
China
State/province [1] 0 0
Beijing
Country [2] 0 0
Korea, Republic of
State/province [2] 0 0
Seoul
Country [3] 0 0
New Zealand
State/province [3] 0 0
Wellington
Country [4] 0 0
Taiwan
State/province [4] 0 0
Taipei

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Mundipharma Research Limited
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
The purpose of this study is to investigate whether flutiform® is effective and safe in the
treatment of chronic obstructive pulmonary disease (COPD).
Trial website
https://clinicaltrials.gov/ct2/show/NCT02195375
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT02195375