Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD

May 22, 2014 updated by: Boehringer Ingelheim

A Randomised, Phase II, Double-Blind, Double-Dummy, Four-period Crossover Efficacy and Safety Comparison of 4-Week Treatment Periods of Blinded Fluticasone (500 mcg Bid, MDI), Ciclesonide (400 mcg qd, MDI), Ciclesonide (800 mcg qd, MDI) or Placebo in Free Combination With Open-Label Tiotropium (18 mcg qd, HandiHaler) and Salmeterol (50 mcg Bid, Diskus) in Patients With COPD.

This efficacy and safety study compares four different combinations of blinded inhaled steroid treatments on top of open-label tiotropium and salmeterol in patients with chronic obstructive pulmonary disease (COPD). The primary objective is the effect on lung function parameters.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
103

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Belgium
      • Genk, Belgium
        • 1249.1.32003 Boehringer Ingelheim Investigational Site
      • Gent, Belgium
        • 1249.1.32001 Boehringer Ingelheim Investigational Site
      • Hasselt, Belgium
        • 1249.1.32002 Boehringer Ingelheim Investigational Site
      • Oostende, Belgium
        • 1249.1.32004 Boehringer Ingelheim Investigational Site
  • Denmark
      • Aarhus C, Denmark
        • 1249.1.45001 Boehringer Ingelheim Investigational Site
  • Germany
      • Großhansdorf, Germany
        • 1249.1.49001 Boehringer Ingelheim Investigational Site
      • Mannheim, Germany
        • 1249.1.49002 Boehringer Ingelheim Investigational Site
      • Weinheim, Germany
        • 1249.1.49003 Boehringer Ingelheim Investigational Site
  • Netherlands
      • Eindhoven, Netherlands
        • 1249.1.31002 Boehringer Ingelheim Investigational Site
      • Harderwijk, Netherlands
        • 1249.1.31003 Boehringer Ingelheim Investigational Site
      • Heerlen, Netherlands
        • 1249.1.31001 Boehringer Ingelheim Investigational Site
      • Veldhoven, Netherlands
        • 1249.1.31004 Boehringer Ingelheim Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Relatively stable, moderate to severe COPD
  • Male or female patients 40 years of age or older.
  • Current or ex-smokers with a smoking history of more than 10 pack years

Exclusion Criteria:

  • Other significant disease that can influence the study results or be a safety risk for the patient
  • Other medication that can influence the study results
  • Hypersensitivity to the study medication
  • Patients with unstable COPD

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Placebo Comparator: Placebo
Drug: Tiotropium
Oral inhalation by HandiHaler® device
Drug: Salmeterol
Oral inhalation from Diskus®
Drug: Placebo
Oral inhalation from MDI
Experimental: Tiotropium+salmeterol+fluticasone
Drug: Tiotropium
Oral inhalation by HandiHaler® device
Drug: Salmeterol
Oral inhalation from Diskus®
Drug: Fluticasone
Oral inhalation from metered dose inhaler (MDI)
Experimental: Tiotropium+salmeterol+ciclesonide low
Drug: Tiotropium
Oral inhalation by HandiHaler® device
Drug: Salmeterol
Oral inhalation from Diskus®
Drug: Ciclesonide low
Oral inhalation from MDI
Experimental: Tiotropium+salmeterol+ciclesonide high
Drug: Tiotropium
Oral inhalation by HandiHaler® device
Drug: Salmeterol
Oral inhalation from Diskus®
Drug: Ciclesonide high
Oral inhalation from MDI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Trough FEV1 response at the end of each 4 week period of randomised treatment
Time Frame: 4 weeks
4 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment
Time Frame: after 4 weeks of each blinded treatment
after 4 weeks of each blinded treatment
All adverse events
Time Frame: 24 weeks
24 weeks
Pulse rate and blood pressure (seated)
Time Frame: 24 weeks
24 weeks
FEV1 and FVC morning peak response
Time Frame: day 1 and day 28 of each blinded treatment
day 1 and day 28 of each blinded treatment
FEV1 and FVC evening peak response
Time Frame: day 1 and day 28 of each blinded treatment
day 1 and day 28 of each blinded treatment
FEV1 AUC (0-3h), after 4 weeks of each blinded treatment
Time Frame: after 4 weeks of each blinded treatment
after 4 weeks of each blinded treatment
FEV1 AUC (12-15h) after 4 weeks of each blinded treatment
Time Frame: after 4 weeks of each blinded treatment
after 4 weeks of each blinded treatment
FVC AUC (0-3h) after 4 weeks of each blinded treatment
Time Frame: after 4 weeks of each blinded treatment
after 4 weeks of each blinded treatment
FVC AUC (12-15h) after 4 weeks of each blinded treatment
Time Frame: after 4 weeks of each blinded treatment
after 4 weeks of each blinded treatment
Trough and peak inspiratory capacity (IC) and vital capacity (VC) response in the morning of day 1 and at day 28 of each treatment period
Time Frame: day 1 and day 28 of each blinded treatment
day 1 and day 28 of each blinded treatment
Weekly mean pre-dose morning and evening peak expiratory flow (PEF)
Time Frame: 28 weeks
28 weeks
Weekly mean number of occasions of rescue therapy used per day
Time Frame: 28 weeks
28 weeks
Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period
Time Frame: 28 weeks
28 weeks
Fractional exhaled nitric oxide after 4 weeks of each blinded treatment
Time Frame: after 4 weeks of each blinded treatment
after 4 weeks of each blinded treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Boehringer Ingelheim

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 1, 2007

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2008

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 25, 2007

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 25, 2007

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 26, 2007

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 30, 2014

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 22, 2014

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 1249.1
  • Eudract2007-003169-42

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Conditions

Rare Diseases

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Locations

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