Study to Investigate the Effect of Formoterol vs Salmeter... | NCT01344655

Studies
Study to Investigate the Effect of Formoterol vs Salmeterol on Small Airways Physiological Parameters in COPD Patients

NCT01344655

Sponsor

Chiesi Farmaceutici S.p.A.

Status

Completed

Last Update Posted

Mar 30, 2017Actual

Enrollment

16Actual

Phase

Phase 4

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

Atimos®
Serevent™
Placebo

Countries

United Kingdom

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
2008-008656-16	EudraCT Number

Status Module

Record Verification Date

Mar 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2011

Primary Completion Date

Sep 2012Actual

Completion Date

Sep 2012Actual

First Submitted Date

Nov 29, 2010

First Submission Date that Met QC Criteria

Apr 28, 2011

First Posted Date

Apr 29, 2011Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 28, 2017

Last Update Posted Date

Mar 30, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This is a crossover Study to investigate the effect of Formoterol versus Salmeterol on small airways physiological parameters in COPD patients.

Detailed Description

A Single-centre, Double-blind, Double-dummy, Randomised, Crossover Study to investigate the effect of Formoterol HFA-pMDI versus Salmeterol HFA-pMDI on small airways physiological parameters in COPD patients.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

16Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Formoterol 12 μg pMDI (Atimos®)	Experimental	Drug: Atimos®
Salmeterol 25 µg pMDI HFA (Serevent™)	Active Comparator	Drug: Serevent™
Matched Placebo	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Atimos®	Drug	Formoterol 12 μg pMDI	Formoterol 12 μg pMDI (Atimos®)

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Respiratory Impedance by Impulse oscillometry		from 5 minutes to 8 hours post dose

Secondary Outcomes

Measure	Description	Time Frame
Exhaled Nitric Oxide		from 30 minutes to 8 hours post dose
Multiple Breath Nitrogen Washout		from 30 minutes to 8 hours post dose
Forced Expiratory Volume in the 1st second

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients with a clinical diagnosis of COPD
Post bronchodilator FEV1 between 30% and 80% predicted values at screening
Post-bronchodilator FEV1/FVC < 0.7

Exclusion Criteria:

Positive FEV1 reversibility test: FEV1 change greater than 200 mL and 12%
History of another medical condition contraindicating participation in the study
Clinical evidence of heart failure

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

40 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Omar S Usmani, MD	Imperial College London	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Airway Disease Section, NHLI, Imperial College London		London		SW3 6LY	United Kingdom

Label	URL
Study Record on EU Clinical Trials Register including results	View source

Condition Browse Module

MeSH Terms

ID	Term
D029424	Pulmonary Disease, Chronic Obstructive

Ancestor Terms

ID	Term
D008173	Lung Diseases, Obstructive
D008171	Lung Diseases
D012140	Respiratory Tract Diseases
D002908	Chronic Disease

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068299	Salmeterol Xinafoate

Ancestor Terms

ID	Term
D000420	Albuterol
D004983	Ethanolamines
D000605	Amino Alcohols
D000438	Alcohols
D009930

Browse Leaves

Not provided

Browse Branches

Not provided