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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.
Sponsor:
Information provided by:
Chiesi Farmaceutici S.p.A.
ClinicalTrials.gov Identifier:
NCT01070524
First received: February 17, 2010
Last updated: May 4, 2011
Last verified: February 2010
History of Changes
  Purpose

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
Asthma
 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:

MedlinePlus related topics: Asthma
Drug Information available for: Budesonide
U.S. FDA Resources

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

  Eligibility

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

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01070524

Locations
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.
Investigators
Principal Investigator: Dave Singh, MD The Medicines Evaluation Unit Ltd
  More Information

No publications provided

Responsible Party: Dr. Dave Singh, The Medicines Evaluation Unit Ltd
ClinicalTrials.gov 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:
Asthma
Bronchial Diseases
Respiratory Tract Diseases
Lung Diseases, Obstructive
Lung Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Budesonide
Fluticasone, salmeterol drug combination
Bronchodilator Agents
 Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Inflammatory Agents
Sympathomimetics

ClinicalTrials.gov processed this record on June 17, 2013