Skip to main content
OpenTrials
Completed

NCT Number: NCT01070524

Cross-over Study to Evaluate the Effect on Trough Forced Expiratory Volume in One Second (FEV1) After 4 Weeks Treatment With CHF 5188 pMDI qd in Adult Patients With Persistent Asthma

Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Asthma Bronchial Diseases Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Lung Diseases Lung Diseases, Obstructive Respiratory Hypersensitivity Respiratory Tract Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road

Manchester, M23 9QZ, United Kingdom

About this study

A randomised, double-blind, multinational, multicentre, active-controlled, 3-way cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with moderate or severe persistent asthma

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Moderate or severe asthma partly controlled with ICS or ICS/LABA
  • FEV1 ≥ 60% and ≤ 90% of predicted for the patient normal value

Exclusion criteria

  • Diagnosis of COPD
  • History or current evidence of significant cardiovascular disease
  • Uncontrolled concomitant disease

Treatment and study plan

CHF 5188 pMDI

Drug

CHF 5188: fixed combination budesonide/carmoterol

Budesonide extrafine pMDI

Drug

Budesonide extrafine pMDI

Seretide(r) Evohaler(r)

Drug

Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol

Primary outcomes

  1. Trough FEV1 (mean 23h-24h FEV1)

    Time frame: after day 28 dose

Secondary outcomes

  1. Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h)

    Time frame: after day 1 dose

  2. Trough FVC (mean 23-24h)

    Time frame: after day 28 dose

  3. Peak FEV1 and FVC

    Time frame: on day 1 and day 28

  4. FEV1 AUC0-24

    Time frame: after day 1 and day 28

Sponsors and collaborators

Lead sponsor

Chiesi Farmaceutici S.p.A.

Industry

Registry information

Official study title

A Randomised, Double-blind, Active-controlled, 3 Way Cross-over Study to Evaluate the Effect on Trough FEV1 After 4 Weeks Treatment With CHF 5188 pMDI qd (Fixed Combination Budesonide / Carmoterol) in Adult Patients With Moderate or Severe Persistent Asthma

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
Feb 18, 2010
Registry last updated
Mar 30, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.