NCT01202084

Brief Summary

The primary objective will be to compare the impact of the study formulations on pulmonary function in persistent asthma carriers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
222

participants targeted

Target at P25-P50 for phase_3 asthma

Timeline
Completed

Started Jan 2012

Shorter than P25 for phase_3 asthma

Geographic Reach
1 country

1 active site

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

September 14, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 15, 2010

Completed
1.3 years until next milestone

Study Start

First participant enrolled

January 1, 2012

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2012

Completed
Last Updated

June 18, 2015

Status Verified

May 1, 2012

Enrollment Period

10 months

First QC Date

September 14, 2010

Last Update Submit

June 17, 2015

Conditions

Asthma

Outcome Measures

Primary Outcomes (1)

  • Forced expiratory volume in 1 second (FEV1) at final visit.

    12 weeks

Secondary Outcomes (1)

  • Peak expiratory flow (PEF)

    12 weeks

Study Arms (3)

Formoterol/Fluticasone Eurofarma

EXPERIMENTAL

formoterol + fluticasone (12/250 mcg) twice a day per 12 weeks

Drug: Formoterol/Fluticasone

Foraseq®

ACTIVE COMPARATOR

formoterol + budedonide (12/400 mcg) twice a day per 12 weeks

Drug: Foraseq®

Fluticasone

ACTIVE COMPARATOR

fluticasone (500 mcg) twice a day per 12 weeks

Drug: Fluticasone

Interventions

Formoterol/FluticasoneDRUG
Formoterol/Fluticasone Eurofarma
Foraseq®DRUG
Foraseq®
FluticasoneDRUG
Fluticasone

Eligibility Criteria

Age12 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Sign the ICF
  • Age ≥ 12 years
  • Persistent asthma diagnosis, as per the GINA classification (www.ginasthma.com),18 with symptoms for at least 6 months and clinically stable for at least 1 month, with the ACQ-745 test (see Appendix C) ≤ 3.0
  • Current use of inhaled corticosteroid (beclomethasone dipropionate dose of up to 1000 µg), associated or not with long-term β2-adrenergic agents and breakthrough medication (salbutamol or equivalent)
  • Initial FEV1 of at least 40% of the predicted normal value
  • Serum cortisol assessment within normal values.

You may not qualify if:

  • Use of oral or parenteral corticosteroid within the 3 months prior to study beginning
  • Requirement of admission due to asthma within the 3 months prior to study beginning
  • Presence of active smoking, defined as the use of cigarette, pipe, cigar or any form of smoking at any amount within the last 3 months
  • Presence of severe co-morbidities, such as cardiovascular, renal, liver, neurological, neoplastic, hematological, infectious, dermatological, neurological, psychiatric or chronic respiratory disease other than asthma
  • Recent (\< 6 months) or predicted participation during this study in other clinical studies involving drugs of any nature or in studies of any form of intervention for treating asthma
  • Intolerance or allergy to any of the components of the drugs assessed in the study
  • Pregnancy or lactation
  • Chronic use of β-blocker medications, per routine oral or intravenous route, or also as ophthalmic solutions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

IMA Brasil - Instituto de Pesquisa Clínica e Medicina Avançada

São Paulo, Brazil

Location

Related Publications (1)

  • 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

MeSH Terms

Conditions

Asthma

Interventions

fluticasone-formoterolFluticasone

Condition Hierarchy (Ancestors)

Bronchial DiseasesRespiratory Tract DiseasesLung Diseases, ObstructiveLung DiseasesRespiratory HypersensitivityHypersensitivity, ImmediateHypersensitivityImmune System Diseases

Intervention Hierarchy (Ancestors)

AndrostadienesAndrostenesAndrostanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 14, 2010

First Posted

September 15, 2010

Study Start

January 1, 2012

Primary Completion

November 1, 2012

Study Completion

November 1, 2012

Last Updated

June 18, 2015

Record last verified: 2012-05

Locations

BR(1)