NCT00901368

Brief Summary

Double blind, multinational, multicentre, randomised, 2 arm parallel group study

Trial Health

90
On Track

Trial Health Score

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

Enrollment
431

participants targeted

Target at P75+ for phase_4

Timeline
Completed

Started May 2009

Geographic Reach
4 countries

4 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

Study Start

First participant enrolled

May 1, 2009

Completed
11 days until next milestone

First Submitted

Initial submission to the registry

May 12, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 13, 2009

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2010

Completed
Last Updated

March 30, 2017

Status Verified

March 1, 2017

Enrollment Period

1.3 years

First QC Date

May 12, 2009

Last Update Submit

March 28, 2017

Conditions

Asthmatic Patients

Outcome Measures

Primary Outcomes (1)

  • Pre-dose morning FEV1 measured at clinic visit 5

    12-week treatment

Secondary Outcomes (8)

  • FEV1 area under the curve (AUC) in the first hour post-dose measured at clinics at visit 2 and visit 5

    12-week treatment

  • Pulmonary function tests measured at clinics (FEV1,PEF, FVC, FEF25-75%)

    12-week treatment

  • ACQ score at baseline and at the end of treatment period

    12-week treatment

  • Use of rescue medication

    12-week treatment

  • Number of patients with controlled or partly controlled asthma at clinic visits according to GINA guidelines revised version 2007

    12-week treatment

  • +3 more secondary outcomes

Study Arms (2)

1

EXPERIMENTAL

CHF1535 (beclometasone dipropionate plus formoterol, 400/24 µg daily)

Drug: FOSTER

2

ACTIVE COMPARATOR

Seretide® Diskus® (fluticasone plus salmeterol, 500/100 µg /daily)

Drug: Seretide

Interventions

FOSTERDRUG

CHF1535 (beclometasone dipropionate 100 µg plus formoterol 6 µg) pMDI aerosol via HFA-134a propellant 2 inhalations b.i.d. (daily dose 400 µg + 24µg)

1
SeretideDRUG

Fluticasone 250 µg + salmeterol 50 µg DPI (Seretide® Diskus®) 1 inhalation b.i.d. (daily dose 500+100 µg)

2

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Asthmatic patients will be enrolled at Visit 1 into the run-in period if they meet all of the following criteria:
  • Written informed consent obtained
  • Adult male and female (≥18 and ≤65 years)
  • Clinical diagnosis of controlled asthma according to Global Strategy for Asthma Management and Prevention (GINA) revised version 2007 in the previous week before study entry:
  • no daytime symptoms (twice or less/week)
  • no limitations of activities
  • no nocturnal symptoms/awakenings
  • no need for reliever/rescue medications (twice or less/week)
  • lung function (FEV1) \> 80% predicted or personal best (if known)
  • Patients treated with fluticasone 500 µg + salmeterol 100 µg daily for ≥ 4 weeks
  • A co-operative attitude and ability to correctly use the device and to complete the diary cards.

You may not qualify if:

  • Patients will not be enrolled at visit 1 into the run-in period if they meet any of the following criteria:
  • Inability to carry out pulmonary function testing;
  • Diagnosis of Chronic Obstructive Pulmonary Disease (COPD) as defined by the National Heart Lung and Blood Institute/World Health Organisation (NHLBI/WHO) Global Initiative for Chronic Obstructive Lung Disease (GOLD) guidelines;
  • History of near fatal asthma;
  • Evidence of severe asthma exacerbation or symptomatic infection of the lower airways in the previous six months;
  • Three or more courses of oral corticosteroids or hospitalisation due to asthma during the previous 6 months;
  • Patients treated with long-acting β2-agonists (LABAs) other than salmeterol, anticholinergics, and leukotriene antagonists during the previous 4 weeks;
  • Current smokers or recent (less than one year) ex-smokers defined as smoking at least 15 packs/year;
  • Clinically significant or unstable concurrent disease : e.g. uncontrolled hyperthyroidism, uncontrolled diabetes mellitus or other endocrine disease; significant hepatic impairment; significant renal impairment; significant other pulmonary disease; cardiovascular disease; gastrointestinal disease; neurological disease; haematological disease, autoimmune disorders, that may interfere with patient's safety, compliance, or study evaluations, according to the investigator's opinion;
  • Patients with a serum potassium value ≤ 3.5 mEq/L
  • Patients with QTc interval (Bazett's formula) higher than 450 msec at screening visit 1;
  • Cancer or any chronic diseases with prognosis \< 2 years;
  • Female subjects: pregnant or with active desire to be pregnant, lactating mother or lack of efficient contraception in a subject with child-bearing potential (i.e. contraceptive methods other than oral contraceptives, IUD, tubal ligature). A pregnancy test in urine is to be carried out in women of a fertile age at screening
  • Significant alcohol consumption or drug abuse;
  • Patients treated with beta-blockers as regular use;
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Hôpital Nord

Marseille, 13015, France

Location

Allergologie imUmkreis der Praxis Pneumologie

Gelsenkirchen, North Rhine-Westphalia, 45879, Germany

Location

Atrium Medisch Centrum Heerlen,

Heerlen, 6419 PC, Netherlands

Location

Hospital Universitario La Fe

Valencia, 46009, Spain

Location

Related Publications (2)

  • Barnes N, van Noord JA, Brindicci C, Lindemann L, Varoli G, Perpina M, Guastalla D, Casula D, Patel S, Chanez P; FACTO (Foster(R) As Complete Treatment Option) Study Group. Stepping-across controlled asthmatic patients to extrafine beclometasone/formoterol combination. Pulm Pharmacol Ther. 2013 Oct;26(5):555-61. doi: 10.1016/j.pupt.2013.01.011. Epub 2013 Mar 22.

    PMID: 23524015RESULT

  • Oba Y, Anwer S, Maduke T, Patel T, Dias S. Effectiveness and tolerability of dual and triple combination inhaler therapies compared with each other and varying doses of inhaled corticosteroids in adolescents and adults with asthma: a systematic review and network meta-analysis. Cochrane Database Syst Rev. 2022 Dec 6;12(12):CD013799. doi: 10.1002/14651858.CD013799.pub2.

    PMID: 36472162DERIVED

Related Links

MeSH Terms

Interventions

Foster Home CareFluticasone-Salmeterol Drug Combination

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsCommunity Health ServicesHealth ServicesHealth Care Facilities Workforce and ServicesSalmeterol XinafoateAlbuterolEthanolaminesAmino AlcoholsAlcoholsOrganic ChemicalsAminesPhenethylaminesEthylaminesFluticasoneAndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic CompoundsDrug CombinationsPharmaceutical Preparations

Study Officials

  • Neil Barnes, MD

    Department ofRespiratory Medicine, London Chest Hospital, Barts& The London NHS Trust,Bonner Road, E2 9JX, London (UK)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 12, 2009

First Posted

May 13, 2009

Study Start

May 1, 2009

Primary Completion

September 1, 2010

Study Completion

December 1, 2010

Last Updated

March 30, 2017

Record last verified: 2017-03

Locations

DE(1)ES(1)FR(1)NL(1)