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Efficacy and Safety of CHF 1535 200/6µg in Not Adequately Controlled Asthmatic Patients

NCT01577082 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 542

Last updated 2026-03-19

Study results available
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Summary

Primary objective

To show the superiority of CHF 1535 (BDP/FF) pMDI (800/24 μg per day) over BDP HFA pMDI (800 μg per day) in terms of change from baseline to the entire treatment period in average pre-dose morning peak expiratory flow (PEF) in adult asthmatic patients not adequately controlled on high doses of ICS or on medium doses of ICS plus LABA.

Secondary objective

To evaluate the effect of CHF 1535 pMDI on clinical outcome measures and other lung function parameters and to evaluate the safety and tolerability profile.

Conditions

Interventions

DRUG

CHF1535 200/6 µg pMDI

2 inhalations BID Total Daily Dose = 800/24 µg

DRUG

BDP HFA 100 µg pMDI

4 inhalations BID Total Daily Dose = 800 µg

Sponsors & Collaborators

  • Chiesi Farmaceutici S.p.A.

    lead INDUSTRY

Principal Investigators

  • Pierluigi Paggiaro, MD, PhD · Cardio-Thoracic and Vascular Dept, University of Pisa

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2012-04-20
Primary Completion
2012-11-29
Completion
2012-11-29

Countries

  • Bulgaria
  • Czechia
  • France
  • Germany
  • Hungary
  • Italy
  • Poland
  • Russia
  • 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 NCT01577082 on ClinicalTrials.gov