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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:
ClinicalTrials.gov Identifier:
NCT01070524
First Posted: February 18, 2010
Last Update Posted: March 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Chiesi Farmaceutici S.p.A.
  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
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, 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 ]

Secondary Outcome Measures:
  • Trough FEV1 and forced vital capacity (FVC) (mean 23h-24h) [ Time Frame: after day 1 dose ]
  • Trough FVC (mean 23-24h) [ Time Frame: after day 28 dose ]
  • Peak FEV1 and FVC [ Time Frame: on day 1 and day 28 ]
  • FEV1 AUC0-24 [ Time Frame: after day 1 and day 28 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Additional Information:
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
2009-013759-32 ( EudraCT Number )
First Submitted: February 17, 2010
First Posted: February 18, 2010
Last Update Posted: March 30, 2017
Last Verified: March 2017

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 Propionate, Salmeterol Xinafoate Drug Combination
Anti-Inflammatory Agents
Bronchodilator Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Sympathomimetics