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Clinical Trial Results:
A randomised, double-blind, double dummy, parallel group study comparing Fluticasone propionate / formoterol fumarate (flutiform®) 250/10 μg (2 puffs BID) and flutiform® 125/5 μg (2 puffs BID) versus Formoterol fumarate dihydrate (Atimos®) 12 μg (1 puff BID) in subjects with chronic obstructive pulmonary disease (COPD).

Summary
EudraCT number	2012-004162-17
Trial protocol	DE GB HU LV LT BG ES CZ SK
Global end of trial date	04 May 2016

Results information
Results version number	v1(current)
This version publication date	19 May 2017
First version publication date	19 May 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
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Trial information

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Sponsor protocol code

FLT3509

ISRCTN number

US NCT number

NCT01946620

WHO universal trial number (UTN)

Sponsor organisation name

Mundipharma Research Ltd.

Sponsor organisation address

194-198 Cambridge Science Park, Cambridge, United Kingdom, CB4 0GW

Public contact

European Medical Operations, Mundipharma Research Limited, +44 1223 424900 , info@contact-clinical-trials.com

Scientific contact

European Medical Operations, Mundipharma Research Limited, +44 1223 424900 , info@contact-clinical-trials.com

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

04 May 2016

Is this the analysis of the primary completion data?

Yes

Primary completion date

04 May 2016

Global end of trial reached?

Yes

Global end of trial date

04 May 2016

Was the trial ended prematurely?

Main objective of the trial

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 during the 52-week treatment period.

Protection of trial subjects

The population that was enrolled was selected on the basis of multiple prior trials which have demonstrated the benefits of ICS-LABA treatment in this target group. In order to reduce risks of participation in a 12-month study subjects were asked to complete an electronic diary, the EXACT-PRO, on a daily basis. This tool has been rigorously developed and has undergone extensive validation. This questionnaire took about 5 minutes to complete. If a subject’s score increased by ≥ 9 points for 3 consecutive days, or ≥ 12 points for 2 consecutive days, compared to baseline, which were validated “exacerbation” thresholds, an alert was sent to both the subject and the Investigator to trigger patient-physician contact to determine whether the subject needed to attend clinic for an unscheduled visit to have their symptoms reviewed. This process provided a robust safety net in excess of that used in the vast majority of previous COPD studies.

Background therapy

Subjects entered a 2-week, open-label, run-in phase during which they ceased their current maintenance treatment and commenced tiotropium (Spiriva® Handihaler®). The run-in phase was intended to ensure a standardised baseline in all subjects such that changes from baseline represented the same change in all patients. Tiotropium was selected as run-in therapy in order to avoid selection bias (or enrichment) during the run-in period which might favour either of the study treatments to which patients are subsequently randomised. Tiotropium is also recommended therapy for category C and D patients and as such is appropriate. Salbutamol 100 μg was used as rescue medication in the run-in and treatment period.

Evidence for comparator

The active components of flutiform are the inhaled glucocorticosteroid (ICS) fluticasone-17-propionate and the inhaled long acting β2-agonist (LABA) formoterol fumarate. Both have both been on the market for many years, and the safety and tolerability of both have been extensively documented in the literature Given the literature, it was expected that both fluticasone doses of 250 and 500 ug BID within flutiform would confer incremental benefit over formoterol monotherapy, whilst also allowing the potential approval of a fluticasone dose half that previously approved as being safe and effective for COPD in the EU.

Actual start date of recruitment

15 Jul 2013

Long term follow-up planned

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country