Pulmonary Disease, Chronic ObstructivePhase 2NCT00535366
Efficacy and Safety Comparison of Steroid or Placebo in Combination With Salmeterol and Tiotropium in COPD
A Phase 2 study testing Tiotropium, Salmeterol and Fluticasone in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 12 sites in 4 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 40 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium, Salmeterol and Fluticasone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 103 participants
- Where
- 12 sitesin 4 countries
- Study dates
- Oct 2007to Sep 2008
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
12 sites in 4 countries.
12 sites in 4 countries
Belgium4 sites
1249.1.32003 Boehringer Ingelheim Investigational Site
Genk
1249.1.32001 Boehringer Ingelheim Investigational Site
Ghent
1249.1.32002 Boehringer Ingelheim Investigational Site
Hasselt
1249.1.32004 Boehringer Ingelheim Investigational Site
Ostend
Netherlands4 sites
1249.1.31002 Boehringer Ingelheim Investigational Site
Eindhoven
1249.1.31003 Boehringer Ingelheim Investigational Site
Harderwijk
1249.1.31001 Boehringer Ingelheim Investigational Site
Heerlen
1249.1.31004 Boehringer Ingelheim Investigational Site
Veldhoven
Germany3 sites
1249.1.49001 Boehringer Ingelheim Investigational Site
Großhansdorf
1249.1.49002 Boehringer Ingelheim Investigational Site
Mannheim
1249.1.49003 Boehringer Ingelheim Investigational Site
Weinheim
About this study
Official title: 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.
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium, Salmeterol, Fluticasone, Ciclesonide low, Ciclesonide high
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TiotropiumDrug
Oral inhalation by HandiHaler® device
SalmeterolDrug
Oral inhalation from Diskus®
FluticasoneDrug
Oral inhalation from metered dose inhaler (MDI)
Ciclesonide lowDrug
Oral inhalation from MDI
Ciclesonide highDrug
Oral inhalation from MDI
PlaceboDrug
Oral inhalation from MDI
| Study group | Role | What they receive |
|---|---|---|
| Tiotropium+salmeterol+fluticasone | Experimental | Not described Receives: Drug: Tiotropium; Drug: Salmeterol; Drug: Fluticasone |
| Tiotropium+salmeterol+ciclesonide low | Experimental | Not described Receives: Drug: Tiotropium; Drug: Salmeterol; Drug: Ciclesonide low |
| Tiotropium+salmeterol+ciclesonide high | Experimental | Not described Receives: Drug: Tiotropium; Drug: Salmeterol; Drug: Ciclesonide high |
| Placebo | Placebo comparator | Not described Receives: Drug: Tiotropium; Drug: Salmeterol; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Trough FEV1 response at the end of each 4 week period of randomised treatment
Measured: 4 weeks
Secondary outcomes (14)
Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment
Measured: after 4 weeks of each blinded treatment
All adverse events
Measured: 24 weeks
Pulse rate and blood pressure (seated)
Measured: 24 weeks
FEV1 and FVC morning peak response
Measured: day 1 and day 28 of each blinded treatment
FEV1 and FVC evening peak response
Measured: day 1 and day 28 of each blinded treatment
FEV1 AUC (0-3h), after 4 weeks of each blinded treatment
Measured: after 4 weeks of each blinded treatment
FEV1 AUC (12-15h) after 4 weeks of each blinded treatment
Measured: after 4 weeks of each blinded treatment
FVC AUC (0-3h) after 4 weeks of each blinded treatment
Measured: after 4 weeks of each blinded treatment
FVC AUC (12-15h) after 4 weeks of each blinded treatment
Measured: 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
Measured: day 1 and day 28 of each blinded treatment
Weekly mean pre-dose morning and evening peak expiratory flow (PEF)
Measured: 28 weeks
Weekly mean number of occasions of rescue therapy used per day
Measured: 28 weeks
Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period
Measured: 28 weeks
Fractional exhaled nitric oxide after 4 weeks of each blinded treatment
Measured: after 4 weeks of each blinded treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2007 (estimated)
- Study startOct 2007
- Primary completionSep 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Enrolment
- 103 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim, Study chair, Boehringer Ingelheim
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00535366
- Sponsor's protocol ID
- 1249.1
- Other IDs
- Eudract2007-003169-42
- Status last verified
- May 2014
- First submitted
- 25 Sep 2007
- Last updated
- 30 May 2014
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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.
- ClinicalTrials.gov ID
- NCT00535366
- Acronym / sponsor ID
- 1249.1
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 103 participants (actual)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Sep 2008 (actual)
- First posted
- 26 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Tiotropium+salmeterol+fluticasone | Experimental | Drug: Tiotropium, Drug: Salmeterol, Drug: Fluticasone |
| Tiotropium+salmeterol+ciclesonide low | Experimental | Drug: Tiotropium, Drug: Salmeterol, Drug: Ciclesonide low |
| Tiotropium+salmeterol+ciclesonide high | Experimental | Drug: Tiotropium, Drug: Salmeterol, Drug: Ciclesonide high |
| Placebo | Placebo comparator | Drug: Tiotropium, Drug: Salmeterol, Drug: Placebo |
Who may qualify
- Ages
- 40 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TiotropiumOral inhalation by HandiHaler® device | Drug | Placebo, Tiotropium+salmeterol+ciclesonide high, Tiotropium+salmeterol+ciclesonide low, Tiotropium+salmeterol+fluticasone |
| SalmeterolOral inhalation from Diskus® | Drug | Placebo, Tiotropium+salmeterol+ciclesonide high, Tiotropium+salmeterol+ciclesonide low, Tiotropium+salmeterol+fluticasone |
| FluticasoneOral inhalation from metered dose inhaler (MDI) | Drug | Tiotropium+salmeterol+fluticasone |
| Ciclesonide lowOral inhalation from MDI | Drug | Tiotropium+salmeterol+ciclesonide low |
| Ciclesonide highOral inhalation from MDI | Drug | Tiotropium+salmeterol+ciclesonide high |
| PlaceboOral inhalation from MDI | Drug | Placebo |
Primary outcome
Trough FEV1 response at the end of each 4 week period of randomised treatment
Time frame: 4 weeks
14 secondary outcomes
Trough forced vital capacity (FVC) response after 4 weeks of each blinded treatment
Time frame: after 4 weeks of each blinded treatment
All adverse events
Time frame: 24 weeks
Pulse rate and blood pressure (seated)
Time frame: 24 weeks
FEV1 and FVC morning peak response
Time frame: 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
FEV1 AUC (0-3h), after 4 weeks of each blinded treatment
Time frame: 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
FVC AUC (0-3h) after 4 weeks of each blinded treatment
Time frame: 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
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
Weekly mean pre-dose morning and evening peak expiratory flow (PEF)
Time frame: 28 weeks
Weekly mean number of occasions of rescue therapy used per day
Time frame: 28 weeks
Mahler Dyspnea Indices (TDI) collected at the end of each treatment period and each wash-out period
Time frame: 28 weeks
Fractional exhaled nitric oxide after 4 weeks of each blinded treatment
Time frame: after 4 weeks of each blinded treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Boehringer Ingelheim study chair
Boehringer Ingelheim
12 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tiotropium, Salmeterol and Fluticasone in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 12 sites in 4 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 May 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Belgium, Netherlands, Germany, Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Trough FEV1 response at the end of each 4 week period of randomised treatment (time frame: 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2014.