Pulmonary Disease, Chronic ObstructivePhase 3NCT00274014
Measure of the Long Term Influence of SPIRIVA® in Acute Respiratory Disorders
A Phase 3 study testing Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 55 sites in France.
Trial summary
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD). Read more about this study
- Who is it for?
- Ages 41 years and older
- Conditions the study is for
- Pulmonary Disease, Chronic Obstructive
- What is being tested?
- Tiotropium
- How many people
- 1,000 participants
- Where
- 55 sitesFrance
- Study dates
- Oct 2000to Oct 2003
- Phase
- Phase 3
- 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 41 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
- Diagnosis of COPD according to the European Respiratory Society (ERS) (R95-3225) and matching the following criteria:
- Stable moderate to severe airway obstruction
- Baseline 30 % < FEV1 < 65 % of European Community of Coal and Steel (ECCS) predicted values (R94-1408).
- Baseline FEV1/SVC< 70 %.
- Smoking history > 10 pack-years (p.y.). A p.y. was defined as the equivalent of smoking
- One pack of cigarettes per day for one year.
- History of exacerbation in the past year.
Trial locations and contacts
55 sites in 1 country.
55 sites in 1 country
France55 sites
Clinique Saint Sauveur
Angers, 49000
Boehringer Ingelheim Investigational Site
Annecy, 74000
Clinique la Casamance
Aubagne, 13675
Boehringer Ingelheim Investigational Site
Avrillé, 49240
Hôpital
Bois-Guillaume, 76233
GPL
Caluire-et-Cuire, 69300
Boehringer Ingelheim Investigational Site
Châlons-en-Champagne, 51000
CH Cholet
Cholet, 49235
Boehringer Ingelheim Investigational Site
Cholet, 49300
Hôpital Gabriel Montpied
Clermont-Ferrand, 63003
Clinique des Cèdres
Cornebarrieu, 31700
Clinique Saint Vincent
Épernay, 51200
Centre Hospitalier Auban Moet
Épernay, 51201
Boehringer Ingelheim Investigational Site
Le Blanc-Mesnil, 93156
Boehringer Ingelheim Investigational Site
Le Petit-Quevilly, 76140
Hôpital Calmette
Lille, 59037
Boehringer Ingelheim Investigational Site
Lyon, 69003
Boehringer Ingelheim Investigational Site
Lyon, 69008
CH Lyon Sud
Lyon, 69310
Hôpital de la Croix-Rousse
Lyon, 69317
Hôpital Louis Pradel
Lyon, 69394
Hôpital Louis Pradel
Lyon
Boehringer Ingelheim Investigational Site
Marseille, 13006
Hôpital Ambroise Paré
Marseille, 13006
Hôpital Nord
Marseille, 13015
CHG
Martigues, 13500
Boehringer Ingelheim Investigational Site
Metz, 57000
Hôpital N.D. bon Secours
Metz, 57038
Service des maladies respiratoires
Montpellier, 34000
Centre Hospitalier Universitaire Arnaud de Villeneuve
Montpellier, 34295
Polyclinique Les Fleurs
Ollioules, 83192
Hôpital Hôtel Dieu
Paris, 75004
Hôpital St Antoine
Paris, 75012
CTAR
Paris, 75013
Fondation Saint Joseph
Paris, 75674
Hôpital Cochin
Paris, 75679
Hôpital Bichat-Claude Bernard
Paris, 75877
Hôpital Tenon
Paris, 75970
Groupe Médical Saint Rémi
Reims, 51100
Hôpital Charles Nicolle
Rouen, 76031
CHILTERN
Rueil-Malmaison, 92508
CHD Félix Guyon
Saint Denis de La Réunion, 97405
Nouvelle Clinique Union et Vaurais
Saint-Jean, 31240
Centre Hospitalier Sud-Réunion
Saint-Pierre, 97448
Boehringer Ingelheim Investigational Site
Salon-de-Provence, 13300
Boehringer Ingelheim Investigational Site
Saumur, 49400
Boehringer Ingelheim Investigational Site
Sélestat, 67600
Boehringer Ingelheim Investigational Site
Strasbourg, 67000
Hôpital Hautepierre
Strasbourg, 67098
CHU Purpan
Toulouse, 31059
Cabinet de Pneumologie
Toulouse, 31076
Cabinet Médical
Toulouse, 31300
Clinique Saint Jean Lanquedoc
Toulouse, 31400
CHU Rangueil
Toulouse, 31403
Centre Hospitalier
Villefranche-sur-Saône, 69655
About this study
Official title: Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.
Read the detailed description
This was a multicentre, randomised, double blind, parallel group, placebo-controlled, one year study. It was designed to determine the effect of inhaled tiotropium treatment on airflow obstruction (PEFR), incidence and severity of exacerbations in patients with COPD.
Following an initial 3-week screening period qualifying patients were randomized to either tiotropium or placebo at Visit 2. Patients returned to the clinic at weeks 6 (Visit 3), 12 (Visit 4), 24 (Visit 5), 36 (Visit 6), 48 (Visit 7) and at Week 50 for the conclusion of the trial (Visit 8). The patients received treatment daily for 48 weeks (336 days).
PEFR, as well as use of rescue medication and respiratory condition, were self-assessed by patients and recorded every morning on a graphical diary card every morning. The graphical presentation of these data was supposed to help investigators to detect exacerbations occurring between two consecutive visits.
Details on hospitalizations due to COPD exacerbations were recorded in a special hospitalization booklet.
Study Hypothesis:
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.
Comparison(s):
Tiotropium 18 mcg once daily vs Placebo
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Being tested
- Tiotropium
- 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
What is being measured
The primary outcome is the main question the study is designed to answer.
morning peak expiratory flow rate (PEFR)
Measured: 50 weeks
Secondary outcomes (10)
incidence, severity and duration of exacerbations
Measured: 50 weeks
number of patients with one or more exacerbation
Measured: 50 weeks
rate of PEFR drops
Measured: 50 weeks
number of lost working days
Measured: 50 weeks
number of days of hospitalisation
Measured: 50 weeks
use of rescue medications, type and duration
Measured: 50 weeks
bacterial and viral characterisation of severe exacerbations
Measured: 50 weeks
spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC)
Measured: 50 weeks
plethysmography (RV, TLC) (optional)
Measured: 50 weeks
Adverse events, physical examination
Measured: 50 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jan 2006 (estimated)
- Study startOct 2000
- Primary completionOct 2003
- Study completionOct 2003
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,000 participants
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Boehringer Ingelheim Study Coordinator, Study chair, BI France S.A.S.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00274014
- Sponsor's protocol ID
- 205.214
- Status last verified
- Oct 2013
- First submitted
- 9 Jan 2006
- Last updated
- 1 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inhaled Tiotropium Bromide on Severity of Airflow Obstruction During Long-term Treatment in Patients With Moderately Severe Copd. Impact on Severity and Incidence of Exacerbations.
- ClinicalTrials.gov ID
- NCT00274014
- Acronym / sponsor ID
- 205.214
- Conditions
- Pulmonary Disease, Chronic Obstructive
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,000 participants
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- Oct 2000
- Primary completion
- Oct 2003 (actual)
- Study completion
- Oct 2003
- First posted
- 10 Jan 2006 (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.
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.
Detailed description
This was a multicentre, randomised, double blind, parallel group, placebo-controlled, one year study. It was designed to determine the effect of inhaled tiotropium treatment on airflow obstruction (PEFR), incidence and severity of exacerbations in patients with COPD.
Following an initial 3-week screening period qualifying patients were randomized to either tiotropium or placebo at Visit 2. Patients returned to the clinic at weeks 6 (Visit 3), 12 (Visit 4), 24 (Visit 5), 36 (Visit 6), 48 (Visit 7) and at Week 50 for the conclusion of the trial (Visit 8). The patients received treatment daily for 48 weeks (336 days).
PEFR, as well as use of rescue medication and respiratory condition, were self-assessed by patients and recorded every morning on a graphical diary card every morning. The graphical presentation of these data was supposed to help investigators to detect exacerbations occurring between two consecutive visits.
Details on hospitalizations due to COPD exacerbations were recorded in a special hospitalization booklet.
Study Hypothesis:
The objectives of this study were to evaluate the effect of a one-year treatment with inhaled tiotropium bromide 18 mcg once daily on lung function, incidence and severity of exacerbations in patients with chronic obstructive pulmonary disease (COPD).
The secondary purpose was to explore possible relationships between lung function changes and occurrence of COPD exacerbations and to try to characterize these exacerbations.
Comparison(s):
Tiotropium 18 mcg once daily vs Placebo
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 41 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Tiotropium | Drug | – |
Primary outcome
morning peak expiratory flow rate (PEFR)
Time frame: 50 weeks
10 secondary outcomes
incidence, severity and duration of exacerbations
Time frame: 50 weeks
number of patients with one or more exacerbation
Time frame: 50 weeks
rate of PEFR drops
Time frame: 50 weeks
number of lost working days
Time frame: 50 weeks
number of days of hospitalisation
Time frame: 50 weeks
use of rescue medications, type and duration
Time frame: 50 weeks
bacterial and viral characterisation of severe exacerbations
Time frame: 50 weeks
spirometric evaluation (FEV1, FVC, SVC, MEF25-75 ) and optional measurements (IC)
Time frame: 50 weeks
plethysmography (RV, TLC) (optional)
Time frame: 50 weeks
Adverse events, physical examination
Time frame: 50 weeks
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 1 Nov 2013.
- Related InfoLink provided by the sponsor.
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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 Coordinator study chair
BI France S.A.S.
55 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tiotropium in people with Pulmonary Disease, Chronic Obstructive, run by Boehringer Ingelheim at 55 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 1 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 55 sites in France. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
morning peak expiratory flow rate (PEFR) (time frame: 50 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 1 Nov 2013.