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Study on Foster Efficacy Maintenance and Reliever vs Foster Maintenance + Salbutamol Reliever in Asthmatics (MART2)

NCT00861926 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1714

Last updated 2026-05-07

Study results available
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Summary

Primary objective:

The primary objective of the study was to compare the efficacy of Maintenance and Reliever Therapy (MART) with Foster® 100/6 μg (one inhalation bid) plus additional inhalations as needed, with the standard treatment of Foster® 100/6 μg (one inhalation bid) plus salbutamol 100 μg (Ventolin ®) additional inhalations as needed in not fully controlled asthmatic patients.

Secondary objectives:

The secondary objectives of the study were:

* to evaluate the effect of treatments on lung function parameters and on other clinical outcome measures, and
* to assess the safety and the tolerability of Foster® as MART.

Conditions

Interventions

DRUG

Salbutamol

Administered via a pressurized metered-dose inhaler

DRUG

Beclomethasone dipropionate + Formoterol

Administered via a pressurized metered-dose inhaler

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Alberto Papi, Professor · Universita degli Studi di Ferrara

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-03-20
Primary Completion
2010-12-07
Completion
2010-12-07

Countries

  • Bulgaria
  • Croatia
  • Czechia
  • France
  • Germany
  • Italy
  • Poland
  • Romania
  • Russia
  • Serbia
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00861926 on ClinicalTrials.gov