NCT02195375

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 Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
923

participants targeted

Target at P75+ for phase_2 chronic-obstructive-pulmonary-disease

Timeline
Completed

Started Sep 2014

Typical duration for phase_2 chronic-obstructive-pulmonary-disease

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 16, 2014

Completed
5 days until next milestone

First Posted

Study publicly available on registry

July 21, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

September 1, 2014

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

March 28, 2017

Status Verified

March 1, 2017

Enrollment Period

1.7 years

First QC Date

July 16, 2014

Last Update Submit

March 27, 2017

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary DiseaseFEV1 ≤ 50%

Outcome Measures

Primary Outcomes (1)

  • Average pre-dose FEV1

    26 weeks

Secondary Outcomes (1)

  • Average 1 hour Post dose FEV1, FVC, FEV6

    26 Weeks

Other Outcomes (3)

  • Moderate and Severe COPD Exacerbations

    26 weeks

  • COPD Assessment Test

    Change from baseline to week 8, week 14, week 26

  • Average capacity of daily living during the morning score

    26 weeks

Study Arms (3)

Flutiform 500/20 µg BID

EXPERIMENTAL

Flutiform 250/10 (2 puffs BID)

Drug: Flutiform 500/20 µg BID

Flutiform 250/10 µg BID

EXPERIMENTAL

Flutiform 125/5 (2 puffs BID)

Drug: Flutiform 250/10 µg BID

Seretide Accuhaler 50/500 µg BID

ACTIVE COMPARATOR

Seretide Accuhaler 50/500 (BID)

Drug: Seretide Accuhaler 50/500 µg BID

Interventions

Flutiform 500/20 µg BIDDRUG
Flutiform 500/20 µg BID
Flutiform 250/10 µg BIDDRUG
Flutiform 250/10 µg BID
Seretide Accuhaler 50/500 µg BIDDRUG
Seretide Accuhaler 50/500 µg BID

Eligibility Criteria

Age40 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

Unknown Facility

Fitzroy, Australia

Location

Unknown Facility

Beijing, China

Location

Unknown Facility

Wellington, New Zealand

Location

Unknown Facility

Seoul, South Korea

Location

Unknown Facility

Taipei, Taiwan

Location

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

fluticasone-formoterolBID protein, human

Condition Hierarchy (Ancestors)

Lung Diseases, ObstructiveLung DiseasesRespiratory Tract DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 16, 2014

First Posted

July 21, 2014

Study Start

September 1, 2014

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

March 28, 2017

Record last verified: 2017-03

Locations

NZ(1)AU(1)KR(1)CN(1)TW(1)