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A Study in Patients With Chronic Obstructive Pulmonary Disease

NCT01245569 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 419

Last updated 2026-08-10

Study results available
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Summary

The primary objective of the study was to demonstrate the superiority of Foster® 100/6 (two puffs b.i.d.) versus Seretide® 500/50 (one inhalation b.i.d.), in terms of pulmonary function (AUC0-30min standardized by time of change from pre-dose in FEV1) after drug inhalation in the morning of day 1, and the equivalence between Foster® 100/6 (two puffs b.i.d.) and Seretide® 500/50 (one inhalation b.i.d.) in terms of Transition Dyspnoea Index (TDI) score at day 84 in patients with COPD.

The secondary objectives of the study were:

* To evaluate the efficacy of the test treatments in terms of additional spirometric parameters and of clinical outcome measures;
* To assess the safety and tolerability;
* To perform an exploratory analysis evaluating the consumption of resources deriving from COPD management in the perspective of the Healthcare System.

Conditions

Interventions

DRUG

Beclomethasone Dipropionate - Formoterol

Administered via a pressurized metered-dose inhaler

DRUG

Fluticasone - Salmeterol

Administered via a pressurized metered-dose inhaler

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Dave Singh, MD · The Medicine Evaluation Unit - Manchester, UK

  • Jorgen Vestbo, MD · Dept. of Cardiology and Respiratory Medicine - Copenhagen, Denmark

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-04-12
Primary Completion
2012-03-13
Completion
2012-03-13

Countries

  • Denmark
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Slovakia
  • Spain
  • Turkey (Türkiye)
  • 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 NCT01245569 on ClinicalTrials.gov