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

NCT01946620 | Completed Phase 3

• 2 other identifiers: FLT35092012-004162-17
• Study Type: interventional
• Target: 1,767
• Locations: 15 countries
• Sites: 15

Brief Summary

Efficacy of Fluticasone/Formoterol in COPD Treatment. The Effect study.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Chronic Obstructive Pulmonary Disease; Exacerbations; FEV1 ≤ 50%

Outcome Measures

Primary Outcomes (1)

• Annual rate of moderate and severe COPD exacerbations

  To show superiority in the efficacy of flutiform 250/10 µg (2 puffs BID) compared with formoterol 12 µg (1 puff BID) based on the annual rate of moderate and severe COPD exacerbations

  52 weeks

Secondary Outcomes (2)

• Annual rate of moderate and severe COPD exacerbations

  52 Weeks

• Efficacy confirmed by lack of exacerbations, lung function and safety by collection of adverse events in all patients throughout the study.

  52 Weeks

Study Arms (3)

Flutiform 250/10 micrograms

EXPERIMENTAL

Flutiform 250/10 µg (2 puffs twice daily)

Drug: Flutiform

Flutiform 125/5 micrograms

EXPERIMENTAL

Flutiform 125/5 µg (2 puffs twice daily)

Drug: Flutiform

Formoterol 12 micrograms

ACTIVE COMPARATOR

Formoterol 12 µg 1 puff twice daily

Drug: Formoterol

Interventions

Flutiform DRUG

Flutiform 125/5 micrograms; Flutiform 250/10 micrograms

Formoterol DRUG

Formoterol 12 micrograms

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or Female subjects aged ≥ 40 years at screening visit:
• 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.
• 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
• Smoking history of ≥10 packs per year.
• Diagnosis of COPD
• History of ≥ moderate or severe COPD exacerbations in previous year.
• Willing and able to replace current COPD therapy with study medication.
• Able to demonstrate correct use of a pMDI without a spacer.
• 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 (see section 10)
• 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) at least 12 hours daily or mechanical ventilation
• Chest X-ray or CT scan that reveals evidence of clinically significant abnormalities reflective of active disease 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 or contraindication to any of the study drugs or excipients

Sponsors & Collaborators

• Mundipharma Research Limited: lead

Study Sites (15)

Unknown Facility

Sofia, Bulgaria

Location

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Hamburg, Germany

Location

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Budapest, Hungary

Location

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Riga, Latvia

Location

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Vilnius, Lithuania

Location

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Skopje, North Macedonia

Location

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Trzemeszno Lubuskie, Poland

Location

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Bacau, Romania

Location

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Moscow, Russia

Location

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Prešov, Slovakia

Location

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Cape Town, South Africa

Location

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Gyeonggido, South Korea

Location

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Barcelona, Spain

Location

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Kyiv, Ukraine

Location

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London, United Kingdom

Location

Related Links

• Link to Results

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

fluticasone-formoterol; Formoterol Fumarate

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines

Study Design

• Study Type: interventional
• Phase: phase 3
• 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: September 10, 2013
• First Posted: September 19, 2013
• Study Start: October 1, 2013
• Primary Completion: April 1, 2016
• Study Completion: May 1, 2016
• Last Updated: October 24, 2018

Record last verified: 2018-10

Locations

ES (1); KR (1); UA (1); BU (1); PL (1); SL (1); HU (1); LA (1); ZA (1); RO (1); NO (1); LI (1); RU (1); DE (1); GB (1)