Flutiform® Compared With Seretide® in the Treatment of COPD

Mundipharma

Status and phase: Completed; Phase 3; Phase 2

Conditions: Chronic Obstructive Pulmonary Disease

Treatments: Drug: Flutiform 250/10 µg BID; Drug: Seretide Accuhaler 50/500 µg BID; Drug: Flutiform 500/20 µg BID

Study type: Interventional

Funder types: Industry

Identifiers

NCT02195375

FLT3510

Details and patient eligibility

About

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

Full 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.

Enrollment: 923 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Exclusion:

1. Ongoing moderate or severe exacerbation of COPD in the 2 weeks before screening.
2. Current diagnosis of asthma.
3. Documented evidence of α1-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).

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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923 participants in 3 patient groups

Flutiform 500/20 µg BID

Experimental group

Description:

Flutiform 250/10 (2 puffs BID)

Treatment:

Drug: Flutiform 500/20 µg BID

Flutiform 250/10 µg BID

Experimental group

Description:

Flutiform 125/5 (2 puffs BID)

Treatment:

Drug: Flutiform 250/10 µg BID

Seretide Accuhaler 50/500 µg BID

Active Comparator group

Description:

Seretide Accuhaler 50/500 (BID)

Treatment:

Drug: Seretide Accuhaler 50/500 µg BID