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Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®

Primary Purpose

Chronic Obstructive Pulmonary Disease

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Formoterol
Salmeterol
Placebo
Sponsored by
AstraZeneca
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Obstructive Pulmonary Disease focused on measuring Chronic Obstructive Pulmonary Disease, Onset of effect, COPD, Oxis Turbuhaler

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms
  • A current or previous smoking history equivalent to 10 or more packs per year (1 pack year = 20 cigarettes smoked per day for one year).
  • Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication.

Exclusion Criteria:

  • A history and/or current diagnosis of asthma.
  • Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period.
  • A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40.

Sites / Locations

  • Research Site
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Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Formoterol, then Salmeterol, then Placebo

Salmeterol, then Palcebo, then Formoterol

Placebo, then Formoterol, then Salmeterol

Formoterol, then Placebo, then Salmeterol

Salmeterol, then Formoterol, then Placebo

Placebo, then Salmeterol, then Formoterol

Arm Description

Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler

Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus

Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler

Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler

Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler

Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus

Outcomes

Primary Outcome Measures

FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose
FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1

Secondary Outcome Measures

Average FEV1 During the First 15 Minutes Post Dose
Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1
Average FEV1 During 120 Minutes Post Dose
Average FEV1 during 120 minutes post dose, change versus pre dose FEV1
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1
Adverse Events
Number of participants with at least 1 AE.

Full Information

First Posted
January 12, 2010
Last Updated
September 25, 2012
Sponsor
AstraZeneca
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1. Study Identification

Unique Protocol Identification Number
NCT01048333
Brief Title
Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®
Official Title
A Randomised, Placebo-controlled, Double-blind (Double-dummy Technique),Crossover, Multi-centre Study, to Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler® 9 μg, Compared With Serevent® Diskus® 50 μg.
Study Type
Interventional

2. Study Status

Record Verification Date
September 2012
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
May 2010 (Actual)
Study Completion Date
May 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AstraZeneca

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Primary objective is to evaluate time to onset of effect of formoterol, 9 μg single dose,compared with salmeterol, 50 μg single dose, in patients with moderate COPD.Forced Expiratory Volume in 1 second (FEV1) measured by spirometry 5 minutes postdose. Secondary efficacy variables: Average FEV1 during the first 15 minutes (area under the FEV1 curve from 0 to 15 minutes), Average FEV1 during 120 minutes (area under the FEV1 curve from 0 to 120 minutes)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Obstructive Pulmonary Disease
Keywords
Chronic Obstructive Pulmonary Disease, Onset of effect, COPD, Oxis Turbuhaler

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
109 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Formoterol, then Salmeterol, then Placebo
Arm Type
Experimental
Arm Description
Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Placebo Diskus and Placebo Turbuhaler
Arm Title
Salmeterol, then Palcebo, then Formoterol
Arm Type
Experimental
Arm Description
Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Placebo Diskus and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Arm Title
Placebo, then Formoterol, then Salmeterol
Arm Type
Experimental
Arm Description
Placebo Diskus and Placebo Turbuhaler first,then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
Arm Title
Formoterol, then Placebo, then Salmeterol
Arm Type
Experimental
Arm Description
Formoterol Turbuhaler 9 μg and Placebo Diskus first, then Placebo Diskus and Placebo Turbuhaler, then Salmeterol Diskus 50 μg and Placebo Turbuhaler
Arm Title
Salmeterol, then Formoterol, then Placebo
Arm Type
Experimental
Arm Description
Salmeterol Diskus 50 μg and Placebo Turbuhaler first, then Formoterol Turbuhaler 9 μg and Placebo Diskus, then Placebo Diskus and Placebo Turbuhaler
Arm Title
Placebo, then Salmeterol, then Formoterol
Arm Type
Experimental
Arm Description
Placebo Diskus and Placebo Turbuhaler first, then Salmeterol Diskus 50 μg and Placebo Turbuhaler, then Formoterol Turbuhaler 9 μg and Placebo Diskus
Intervention Type
Drug
Intervention Name(s)
Formoterol
Intervention Description
Formoterol Turbuhaler 9 μg and Placebo Diskus
Intervention Type
Drug
Intervention Name(s)
Salmeterol
Intervention Description
Salmeterol Diskus 50 μg and Placebo Turbuhaler
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo Diskus and Placebo Turbuhaler
Primary Outcome Measure Information:
Title
FEV1(Forced Expiratory Volume in 1 Second) Measured by Spirometry 5 Minutes Post Dose
Description
FEV1(Forced Expiratory Volume in 1 second) measured by spirometry 5 minutes post dose, percentage change versus pre dose FEV1
Time Frame
Pre-dose and 5 minutes post-dose
Secondary Outcome Measure Information:
Title
Average FEV1 During the First 15 Minutes Post Dose
Description
Average FEV1 during the first 15 minutes post dose, change versus pre dose FEV1
Time Frame
Pre dose and 15 minutes post dose
Title
Average FEV1 During 120 Minutes Post Dose
Description
Average FEV1 during 120 minutes post dose, change versus pre dose FEV1
Time Frame
Pre dose and 120 minutes post dose
Title
Percentage of Patients Who Has Achieved at Least 12 % Increase in FEV1
Description
Percentage of patients who has achieved at least 12 % increase in FEV1 at each time point between 5 to 120 minutes post dose, change versus pre dose FEV1
Time Frame
Pre dose, 5, 10, 15, 20, 30, 40, 50, 60 and 120 minutes post dose
Title
Adverse Events
Description
Number of participants with at least 1 AE.
Time Frame
At baseline and at each day of treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: A clinical diagnosis of COPD according to GOLD guidelines, and current COPD symptoms A current or previous smoking history equivalent to 10 or more packs per year (1 pack year = 20 cigarettes smoked per day for one year). Documented use of a short-acting inhaled bronchodilator (β2-agonist or anticholinergics) as reliever medication. Exclusion Criteria: A history and/or current diagnosis of asthma. Patients who have experienced COPD exacerbation requiring hospitalisation and/or a course of antibiotics and/or a course of systemic steroid within 30 days (from end of exacerbation treatment) prior to Visit 1 and/or during the run-in period. A history and/or current diagnosis of atopic diseases such as allergic rhinitis or eczema before the age of 40.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mario Cazzola, professor
Organizational Affiliation
Italy
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Georgios Stratelis
Organizational Affiliation
AstraZeneca MC Sweden
Official's Role
Study Director
Facility Information:
Facility Name
Research Site
City
Bussolengo
Country
Italy
Facility Name
Research Site
City
Cassano Delle Murge
Country
Italy
Facility Name
Research Site
City
Catanzaro
Country
Italy
Facility Name
Research Site
City
Cava dei Tirreni
Country
Italy
Facility Name
Research Site
City
Napoli
Country
Italy
Facility Name
Research Site
City
Palermo
Country
Italy
Facility Name
Research Site
City
Parma
Country
Italy
Facility Name
Research Site
City
Pisa
Country
Italy
Facility Name
Research Site
City
Prato
Country
Italy
Facility Name
Research Site
City
Roma
Country
Italy
Facility Name
Research Site
City
Barcelona
Country
Spain
Facility Name
Research Site
City
Madrid
Country
Spain
Facility Name
Research Site
City
Malaga
Country
Spain
Facility Name
Research Site
City
Goteborg
Country
Sweden
Facility Name
Research Site
City
Linkoping
Country
Sweden
Facility Name
Research Site
City
Lulea
Country
Sweden
Facility Name
Research Site
City
Lund
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
22235841
Citation
Cazzola M, Paggiaro P, Palange P, Bjermer L, Ausin P, Carlsson LG, Ekelund J, Lotvall J. Onset of action of formoterol versus salmeterol via dry powder inhalers in moderate chronic obstructive pulmonary disease: a randomized, placebo-controlled, double-blind, crossover study. Clin Drug Investig. 2012 Mar 1;32(3):147-55. doi: 10.2165/11630880-000000000-00000.
Results Reference
derived

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Evaluate Onset of Effect in Patients With Chronic Obstructive Pulmonary Disease (COPD) Treated With Formoterol Turbuhaler®

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