Status:
COMPLETED
Flutiform® Compared With Seretide® in the Treatment of COPD
Lead Sponsor:
Mundipharma Research Limited
Conditions:
Chronic Obstructive Pulmonary Disease
Eligibility:
All Genders
40+ years
Phase:
PHASE2
PHASE3
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).
Detailed 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...
Eligibility Criteria
Inclusion
- Inclusion:
- Male or Female subjects aged ≥ 40 years at screening visit.
- Diagnosis of COPD
- Willing and able to replace current COPD therapy with study medication.
- Able to demonstrate correct use of a pMDI with or without a spacer and Accuhaler.
- 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 in the 2 weeks before screening.
- 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) or mechanical ventilation. Note: LTOT is defined as \>15 hours use per day
- Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities 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 to study drug or excipients.
- Received an investigational drug within 30 days of the screening visit (12 weeks if an oral or injectable steroid).
Exclusion
Key Trial Info
Start Date :
September 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 1 2016
Estimated Enrollment :
923 Patients enrolled
Trial Details
Trial ID
NCT02195375
Start Date
September 1 2014
End Date
May 1 2016
Last Update
March 28 2017
Active Locations (5)
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1
Fitzroy, Australia
2
Beijing, China
3
Wellington, New Zealand
4
Seoul, South Korea