Cystic FibrosisPhase 2NCT00737100

Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis

A Phase 2 study testing Tiotropium bromide 5 mcg and tiotropium bromide-low dose-2.5mcg in people with Cystic Fibrosis, run by Boehringer Ingelheim at 107 sites in 11 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

This study evaluates the effects of 12-week treatment with two doses of tiotropium bromide (2.5 mcg q.d. and 5 mcg q.d.) compared to placebo administered via the Respimat device on lung function in patients with Cystic Fibrosis. Read more about this study

Who is it for?: Any age
Conditions the study is for: Cystic Fibrosis
What is being tested?: Tiotropium bromide 5 mcg and tiotropium bromide-low dose-2.5mcg
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 510 participants
Where: 107 sitesin 11 countries
Study dates: Sep 2008to Apr 2010
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 Any age
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female patients
Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)
Pre-bronchodilator FEV1 greater/equal 25% of predicted values

Who cannot join

Significant history of allergy/hypersensitivity
Hypersensitivity to study drug
Participation in another trial
Female patients who are pregnant or lactating
Female patients of childbearing potential
Patients who have started a new medication for CF within 4 weeks of screening
Patients with known substance abuse
Clinically significant disease other than CF

Trial locations and contacts

107 sites in 11 countries.

Country

City, postcode or hospital

107 sites in 11 countries

France32 sites

205.339.3310A Boehringer Ingelheim Investigational Site
Amiens
205.339.3317A Boehringer Ingelheim Investigational Site
Angers
205.339.3317C Boehringer Ingelheim Investigational Site
Angers
205.339.3317D Boehringer Ingelheim Investigational Site
Angers
205.339.3317E Boehringer Ingelheim Investigational Site
Angers
205.339.3314A Boehringer Ingelheim Investigational Site
Bron
205.339.3314B Boehringer Ingelheim Investigational Site
Bron
205.339.3314C Boehringer Ingelheim Investigational Site
Bron
205.339.3302A Boehringer Ingelheim Investigational Site
Lille
205.339.3302B Boehringer Ingelheim Investigational Site
Lille
205.339.3302C Boehringer Ingelheim Investigational Site
Lille
205.339.3303A Boehringer Ingelheim Investigational Site
Lisieux
205.339.3304A Boehringer Ingelheim Investigational Site
Montpellier
205.339.3304B Boehringer Ingelheim Investigational Site
Montpellier
205.339.3308A Boehringer Ingelheim Investigational Site
Nantes
205.339.3308B Boehringer Ingelheim Investigational Site
Nantes
205.339.3308C Boehringer Ingelheim Investigational Site
Nantes
205.339.3301B Boehringer Ingelheim Investigational Site
Paris
205.339.3312A Boehringer Ingelheim Investigational Site
Paris
205.339.3312C Boehringer Ingelheim Investigational Site
Paris
205.339.3313A Boehringer Ingelheim Investigational Site
Paris
205.339.3313B Boehringer Ingelheim Investigational Site
Paris
205.339.3318A Boehringer Ingelheim Investigational Site
Rennes
205.339.3318C Boehringer Ingelheim Investigational Site
Rennes
205.339.3318G Boehringer Ingelheim Investigational Site
Rennes
205.339.3315C Boehringer Ingelheim Investigational Site
Roscoff
205.339.3315D Boehringer Ingelheim Investigational Site
Roscoff
205.339.3306A Boehringer Ingelheim Investigational Site
Rouen
205.339.3306B Boehringer Ingelheim Investigational Site
Rouen
205.339.3307A Boehringer Ingelheim Investigational Site
Rouen
205.339.3309A Boehringer Ingelheim Investigational Site
Vandœuvre-lès-Nancy
205.339.3316A Boehringer Ingelheim Investigational Site
Vannes

Other trials in France

United States26 sites

205.339.017 Boehringer Ingelheim Investigational Site
Ann Arbor, Michigan
205.339.010 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
205.339.011 Boehringer Ingelheim Investigational Site
Charlottesville, Virginia
205.339.024 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
205.339.026 Boehringer Ingelheim Investigational Site
Colchester, Vermont
205.339.025 Boehringer Ingelheim Investigational Site
Detroit, Michigan
205.339.004 Boehringer Ingelheim Investigational Site
Fort Worth, Texas
205.339.016 Boehringer Ingelheim Investigational Site
Grand Rapids, Michigan
205.339.014 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
205.339.022 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
205.339.001 Boehringer Ingelheim Investigational Site
Iowa City, Iowa
205.339.023 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
205.339.018 Boehringer Ingelheim Investigational Site
Lebanon, New Hampshire
205.339.029 Boehringer Ingelheim Investigational Site
Long Branch, New Jersey
205.339.021 Boehringer Ingelheim Investigational Site
Miami, Florida
205.339.003 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
205.339.009 Boehringer Ingelheim Investigational Site
Morristown, New Jersey
205.339.020 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
205.339.032 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
205.339.030 Boehringer Ingelheim Investigational Site
Orlando, Florida
205.339.031 Boehringer Ingelheim Investigational Site
Orlando, Florida
205.339.005 Boehringer Ingelheim Investigational Site
Salt Lake City, Utah
205.339.019 Boehringer Ingelheim Investigational Site
San Diego, California
205.339.013 Boehringer Ingelheim Investigational Site
South Bend, Indiana
205.339.002 Boehringer Ingelheim Investigational Site
Syracuse, New York
205.339.006 Boehringer Ingelheim Investigational Site
Tucson, Arizona

Other trials in United States

United Kingdom12 sites

205.339.44180 Boehringer Ingelheim Investigational Site
Belfast
205.339.44190 Boehringer Ingelheim Investigational Site
Birmingham
205.339.44193 Boehringer Ingelheim Investigational Site
Boston
205.339.44192 Boehringer Ingelheim Investigational Site
Leeds
205.339.44191 Boehringer Ingelheim Investigational Site
Lincoln
205.339.44185 Boehringer Ingelheim Investigational Site
Liverpool
205.339.44186 Boehringer Ingelheim Investigational Site
Liverpool
205.339.44183 Boehringer Ingelheim Investigational Site
Nottingham
205.339.44182 Boehringer Ingelheim Investigational Site
Oxford
205.339.44194 Boehringer Ingelheim Investigational Site
Plymouth
205.339.44181 Boehringer Ingelheim Investigational Site
Sheffield
205.339.44184 Boehringer Ingelheim Investigational Site
Wolverhampton

Other trials in United Kingdom

Germany11 sites

205.339.49132 Boehringer Ingelheim Investigational Site
Erlangen
205.339.49137 Boehringer Ingelheim Investigational Site
Frankfurt
205.339.49133 Boehringer Ingelheim Investigational Site
Frankfurt am Main
205.339.49134 Boehringer Ingelheim Investigational Site
Freiburg im Breisgau
205.339.49131 Boehringer Ingelheim Investigational Site
Gerlingen
205.339.49145 Boehringer Ingelheim Investigational Site
Hamburg
205.339.49135 Boehringer Ingelheim Investigational Site
Hanover
205.339.49141 Boehringer Ingelheim Investigational Site
Heidelberg
205.339.49140 Boehringer Ingelheim Investigational Site
München
205.339.49142 Boehringer Ingelheim Investigational Site
München
205.339.49130 Boehringer Ingelheim Investigational Site
Tübingen

Other trials in Germany

Russia8 sites

205.339.07001 Boehringer Ingelheim Investigational Site
Moscow
205.339.07002 Boehringer Ingelheim Investigational Site
Moscow
205.339.07003 Boehringer Ingelheim Investigational Site
Moscow
205.339.07007 Boehringer Ingelheim Investigational Site
Rostov-on-Don
205.339.07005 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.339.07006 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.339.07008 Boehringer Ingelheim Investigational Site
Voronezh
205.339.07004 Boehringer Ingelheim Investigational Site
Yaroslavl

Other trials in Russia

Australia4 sites

205.339.103 Boehringer Ingelheim Investigational Site
Adelaide, South Australia
205.339.104 Boehringer Ingelheim Investigational Site
Subiaco, Western Australia
205.339.100 Boehringer Ingelheim Investigational Site
Westmead, New South Wales
205.339.101 Boehringer Ingelheim Investigational Site
Westmead, New South Wales

Other trials in Australia

Portugal4 sites

205.339.221 Boehringer Ingelheim Investigational Site
Lisbon
205.339.225 Boehringer Ingelheim Investigational Site
Lisbon
205.339.223 Boehringer Ingelheim Investigational Site
Porto
205.339.224 Boehringer Ingelheim Investigational Site
Porto

Other trials in Portugal

Belgium3 sites

205.339.111 Boehringer Ingelheim Investigational Site
Brussels
205.339.112 Boehringer Ingelheim Investigational Site
Jette
205.339.110 Boehringer Ingelheim Investigational Site
Leuven

Other trials in Belgium

Italy3 sites

205.339.233 Boehringer Ingelheim Investigational Site
Ancona
205.339.231 Boehringer Ingelheim Investigational Site
Florence
205.339.234 Boehringer Ingelheim Investigational Site
Genova

Other trials in Italy

Netherlands2 sites

205.339.171 Boehringer Ingelheim Investigational Site
Groesbeek
205.339.170 Boehringer Ingelheim Investigational Site
Rotterdam

Other trials in Netherlands

New Zealand2 sites

205.339.105 Boehringer Ingelheim Investigational Site
Grafton / Auckland
205.339.106 Boehringer Ingelheim Investigational Site
Hamilton

Other trials in New Zealand

About this study

Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.

Conditions: Cystic Fibrosis
Being tested: Placebo Respimat, Tiotropium bromide 5 mcg, tiotropium bromide-low dose-2.5mcg
Medical subject headings: Cystic Fibrosis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Placebo RespimatDrug
patient to receive placebo matching active drug once daily
Tiotropium bromide 5 mcgDrug
patient to recieve high dose tiotropium once daily
tiotropium bromide-low dose-2.5mcgDrug
patient to receive low dose tiotropium once daily

Study groups in NCT00737100
Study group	Role	What they receive
Tiotropium Respimat 2.5 mcg	Experimental	patient to receive low dose tiotropium once daily Receives: Drug: tiotropium bromide-low dose-2.5mcg
Tiotropium Respimat 5 mcg	Experimental	patient to receive high dose tiotropium once daily Receives: Drug: Tiotropium bromide 5 mcg
Placebo Respimat	Placebo comparator	patient to receive placebo once daily Receives: Drug: Placebo Respimat

What is being measured

The primary outcome is the main question the study is designed to answer.

Percent Predicted FEV1 AUC0-4 Response at the End of Week 12
Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Measured: Baseline, Week 12
Percent Predicted FEV1 Trough Response at the End of Week 12
Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline.
Measured: Baseline, Week 12

Secondary outcomes (12)

Percent Predicted FVC AUC0-4 Response at the End of Week 12
Change from baseline in percent predicted Forced Vital Capacity (FVC) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Measured: Baseline, Week 12
Percent Predicted FVC Trough Response at the End of Week 12
Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Measured: Baseline, Week 12
Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12
Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Measured: Baseline, Week 12
Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12
Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.
Measured: Baseline, Week 12
Respiratory and Systemic Symptoms Questionnaire (RSSQ)
Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.
Measured: 12 weeks
Change From Baseline in CFQ Scores - Adult Group
The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adults with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.
Measured: 12 weeks
Change From Baseline in CFQ Scores - Adolescents Group
The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents (age 6-13) with CF. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.
Measured: 12 weeks
Change From Baseline in CFQ Scores - Parent Questionnaire
The Cystic Fibrosis questionnaire (CFQ) is a disease-specific instrument that measures health-related quality of life (HRQOL) for adolescents with CF - parent questionnaire. This validation questionnaire consists of 50 items on generic and disease-specific scales. The scores range from 0 to 100, with higher scores indicating better health.
Measured: 12 weeks
Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)
Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state
Measured: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Maximum Measured Concentration at Steady State (Cmax,ss)
Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.
Measured: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Time From Dosing to the Maximum Concentration (Tmax,ss)
Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma
Measured: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation
Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.
Measured: From first drug administration until 30 days after last drug administration (up to 121 days)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Sep 2008Apr 2010

First posted18 Aug 2008 (estimated)
Study startSep 2008
Primary completionApr 2010

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Cystic FibrosisStudies 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: Parallel groups
Masking: Double blind
Enrolment: 510 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00737100
Sponsor's protocol ID: 205.339
Other IDs: 2008-001156-43, 2008
Status last verified: Jan 2014
First submitted: 15 Aug 2008
Last updated: 16 May 2014
Results posted: Yes, on ClinicalTrials.gov
Expanded access: Available

Publications

Ratjen F, Koker P, Geller DE, Langellier-Cocteaux B, Le Maulf F, Kattenbeck S, Moroni-Zentgraf P, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Tiotropium Respimat in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials. J Cyst Fibros. 2015 Sep;14(5):608-14. doi: 10.1016/j.jcf.2015.03.004. Epub 2015 Mar 26.
PubMed 25819269
Bradley JM, Koker P, Deng Q, Moroni-Zentgraf P, Ratjen F, Geller DE, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Testing two different doses of tiotropium Respimat(R) in cystic fibrosis: phase 2 randomized trial results. PLoS One. 2014 Sep 4;9(9):e106195. doi: 10.1371/journal.pone.0106195. eCollection 2014.
PubMed 25188297

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 16 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-blind, Placebo-controlled Parallel Group Study to Investigate the Safety and Efficacy of Two Doses of Tiotropium Bromide (2.5 mcg and 5 mcg) Administered Once Daily Via the Respimat Device for 12 Weeks in Patients With Cystic Fibrosis.
ClinicalTrials.gov ID: NCT00737100
Acronym / sponsor ID: 205.339
Conditions: Cystic Fibrosis
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 510 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2008
Primary completion: Apr 2010 (actual)
First posted: 18 Aug 2008 (estimated)
Results: Posted 13 Apr 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Number of arms: 3

Arm	Type	Receives
Tiotropium Respimat 2.5 mcg	Experimental	Drug: tiotropium bromide-low dose-2.5mcgpatient to receive low dose tiotropium once daily
Tiotropium Respimat 5 mcg	Experimental	Drug: Tiotropium bromide 5 mcgpatient to receive high dose tiotropium once daily
Placebo Respimat	Placebo comparator	Drug: Placebo Respimatpatient to receive placebo once daily

Who may qualify

Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (3 listed)

Male or female patients
Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)
Pre-bronchodilator FEV1 greater/equal 25% of predicted values

Key exclusion criteria (8 listed)

Significant history of allergy/hypersensitivity
Hypersensitivity to study drug
Participation in another trial
Female patients who are pregnant or lactating
Female patients of childbearing potential

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
Placebo Respimatpatient to receive placebo matching active drug once daily	Drug	Placebo Respimat
Tiotropium bromide 5 mcgpatient to recieve high dose tiotropium once daily	Drug	Tiotropium Respimat 5 mcg
tiotropium bromide-low dose-2.5mcgpatient to receive low dose tiotropium once daily	Drug	Tiotropium Respimat 2.5 mcg

Primary outcome

Percent Predicted FEV1 AUC0-4 Response at the End of Week 12
Time frame: Baseline, Week 12
Outcome measure description: Change from baseline in percent predicted Forced Expiratory Volume in one second (FEV1) Area Under the Curve from 0 to 4 hours (AUC0-4). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Percent Predicted FEV1 Trough Response at the End of Week 12
Time frame: Baseline, Week 12
Outcome measure description: Change from baseline in percent predicted trough Forced Expiratory Volume in one second. Calculated as percent predicted at week 12 minus percent predicted at baseline.

12 secondary outcomes

Percent Predicted FVC AUC0-4 Response at the End of Week 12
Time frame: Baseline, Week 12
Percent Predicted FVC Trough Response at the End of Week 12
Time frame: Baseline, Week 12
Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12
Time frame: Baseline, Week 12
Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12
Time frame: Baseline, Week 12
Respiratory and Systemic Symptoms Questionnaire (RSSQ)
Time frame: 12 weeks
Change From Baseline in CFQ Scores - Adult Group
Time frame: 12 weeks
Change From Baseline in CFQ Scores - Adolescents Group
Time frame: 12 weeks
Change From Baseline in CFQ Scores - Parent Questionnaire
Time frame: 12 weeks
Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)
Time frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Maximum Measured Concentration at Steady State (Cmax,ss)
Time frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Time From Dosing to the Maximum Concentration (Tmax,ss)
Time frame: pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation
Time frame: From first drug administration until 30 days after last drug administration (up to 121 days)

Results and safety

Results posted to the registry on 13 Apr 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo	168	161
Tiotropium Respimat 2.5 Micrograms	166	159
Tiotropium Respimat 5 Micrograms	176	169

Primary outcome: Percent Predicted FEV1 AUC0-4 Response at the End of Week 12

Time frame: Baseline, Week 12. Least squares mean (Standard Error). Unit: Percentage change

Measure	Placebo n = 163	Tiotropium Respimat 2.5 Micrograms n = 158	Tiotropium Respimat 5 Micrograms n = 169
Value	-1.74 (0.65)	1.20 (0.66)	1.65 (0.63)

Placebo vs Tiotropium Respimat 2.5 Micrograms: Mean Difference (Final Values): 2.94 (95% CI 1.19 to 4.70), p = 0.001, Mixed Models Analysis
Placebo vs Tiotropium Respimat 5 Micrograms: Mean Difference (Final Values): 3.39 (95% CI 1.67 to 5.12), p = 0.0001, Mixed Models Analysis

Population analysed: Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement

Primary outcome: Percent Predicted FEV1 Trough Response at the End of Week 12

Time frame: Baseline, Week 12. Least squares mean (Standard Error). Unit: Percentage change

Measure	Placebo n = 163	Tiotropium Respimat 2.5 Micrograms n = 158	Tiotropium Respimat 5 Micrograms n = 169
Value	-1.44 (0.71)	0.81 (0.71)	0.78 (0.69)

Placebo vs Tiotropium Respimat 2.5 Micrograms: Mean Difference (Final Values): 2.24 (95% CI 0.38 to 4.11), p = 0.0184, Mixed Models Analysis
Placebo vs Tiotropium Respimat 5 Micrograms: Mean Difference (Final Values): 2.22 (95% CI 0.38 to 4.06), p = 0.0179, Mixed Models Analysis

Population analysed: Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement

12 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo	21 of 168 (12.5%)	87 of 168 (51.8%)	Not reported
Tiotropium Respimat 2.5 Micrograms	28 of 166 (16.9%)	95 of 166 (57.2%)	Not reported
Tiotropium Respimat 5 Micrograms	21 of 176 (11.9%)	110 of 176 (62.5%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2014.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25819269Ratjen F, Koker P, Geller DE, Langellier-Cocteaux B, Le Maulf F, Kattenbeck S, Moroni-Zentgraf P, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Tiotropium Respimat in cystic fibrosis: Phase 3 and Pooled phase 2/3 randomized trials. J Cyst Fibros. 2015 Sep;14(5):608-14. doi: 10.1016/j.jcf.2015.03.004. Epub 2015 Mar 26.
Derived from this study: PubMed 25188297Bradley JM, Koker P, Deng Q, Moroni-Zentgraf P, Ratjen F, Geller DE, Elborn JS; Tiotropium Cystic Fibrosis Study Group. Testing two different doses of tiotropium Respimat(R) in cystic fibrosis: phase 2 randomized trial results. PLoS One. 2014 Sep 4;9(9):e106195. doi: 10.1371/journal.pone.0106195. eCollection 2014.
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 chair

Boehringer Ingelheim

107 sites in 11 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Tiotropium bromide 5 mcg and tiotropium bromide-low dose-2.5mcg in people with Cystic Fibrosis, run by Boehringer Ingelheim at 107 sites in 11 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 8 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 16 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 107 sites in France, United States, United Kingdom, Germany, Russia and 6 more countries. 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?

Yes. Results are posted in the registry (first posted 13 Apr 2011). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Percent Predicted FEV1 AUC0-4 Response at the End of Week 12 (time frame: Baseline, Week 12). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00737100, which also lists 2 linked publications.

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 16 May 2014.