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

This study has been completed.
Information provided by:
Chiesi Farmaceutici S.p.A. Identifier:
First received: February 17, 2010
Last updated: May 4, 2011
Last verified: February 2010
Cross-over study to evaluate the effect on trough FEV1 after 4 weeks treatment with CHF5188 pMDI qd in adult patients with persistent asthma

Condition Intervention Phase
Drug: CHF 5188 pMDI
Drug: Budesonide extrafine pMDI
Drug: Seretide(r) Evohaler(r)
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official 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

Resource links provided by NLM:

Further study details as provided by Chiesi Farmaceutici S.p.A.:

Primary Outcome Measures:
  • Trough FEV1 (mean 23h-24h FEV1) [ Time Frame: after day 28 dose ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h) [ Time Frame: after day 1 dose ] [ Designated as safety issue: No ]
  • Trough FVC (mean 23-24h) [ Time Frame: after day 28 dose ] [ Designated as safety issue: No ]
  • Peak FEV1 and FVC [ Time Frame: on day 1 and day 28 ] [ Designated as safety issue: No ]
  • FEV1 AUC0-24 [ Time Frame: after day 1 and day 28 ] [ Designated as safety issue: No ]

Estimated Enrollment: 113
Study Start Date: January 2010
Study Completion Date: July 2010
Primary Completion Date: July 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CHF 5188 pMDI Drug: CHF 5188 pMDI
CHF 5188: fixed combination budesonide/carmoterol
Active Comparator: Budesonide extrafine pMDI Drug: Budesonide extrafine pMDI
Budesonide extrafine pMDI
Active Comparator: Seretide(r) Evohaler(r) Drug: Seretide(r) Evohaler(r)
Seretide(r) Evohaler(r): fixed combination fluticasone/salmeterol

Detailed Description:
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

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT01070524

United Kingdom
The Medicines Evaluation Unit Ltd, The Langley Building, Southmoor Road
Manchester, United Kingdom, M23 9QZ
Sponsors and Collaborators
Chiesi Farmaceutici S.p.A.
Principal Investigator: Dave Singh, MD The Medicines Evaluation Unit Ltd
  More Information

Responsible Party: Dr. Dave Singh, The Medicines Evaluation Unit Ltd Identifier: NCT01070524     History of Changes
Other Study ID Numbers: CCD-0909-PR-0020 
Study First Received: February 17, 2010
Last Updated: May 4, 2011
Health Authority: Germany: Ministry of Health
Poland: Ministry of Health
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Additional relevant MeSH terms:
Bronchial Diseases
Hypersensitivity, Immediate
Immune System Diseases
Lung Diseases
Lung Diseases, Obstructive
Respiratory Hypersensitivity
Respiratory Tract Diseases
Anti-Asthmatic Agents
Anti-Inflammatory Agents
Autonomic Agents
Bronchodilator Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Peripheral Nervous System Agents
Physiological Effects of Drugs
Respiratory System Agents processed this record on May 26, 2016