Cystic FibrosisPhase 3NCT01179347

Tiotropium Bromide in Cystic Fibrosis

A Phase 3 study testing tiotropium Respimat® inhaler in people with Cystic Fibrosis, run by Boehringer Ingelheim at 99 sites in 20 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

Who is it for?: Any age
Conditions the study is for: Cystic Fibrosis
What is being tested?: tiotropium Respimat® inhaler
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 464 participants
Where: 99 sitesin 20 countries
Study dates: Sep 2010to Mar 2012
Phase: Phase 3
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

Patients with a documented diagnosis of Cystic Fibrosis (CF) (positive sweat chloride >=60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations.
Male or female patients (children less than 12 years and adolescents >12 years).
Patients >=5 years of age must be able to perform acceptable spirometric maneuvers, according to the American Thoracic Society (ATS) standards.
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) >25% of predicted values.
Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1.
No evidence of respiratory tract infection and no pulmonary exacerbation requiring use of intravenous/oral/inhaled antibiotics, or oral corticosteroids within 2 weeks of screening.

Show all 10Show fewer

The patient or the patient's legally acceptable representative must be able to give informed consent.
Patients who are on a cycling TOBI® regimen must have completed at least 2 cycles every other month TOBI® administration prior to the screening visit.
Patients who are on daily inhaled antibiotic use must be stabilized for at least 6 weeks prior to Visit 1 (screening).
Patients having previously participated in study 205.339 can also be selected.

Who cannot join

Patients with a known hypersensitivity to study drug
Patients who have participated in another study with an Investigational drug within one month preceding the screening visit.
Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from sponsor of other study.
Patients with known relevant substance abuse, including alcohol or drug abuse.
Adolescent and adult female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening.
Female patients of child bearing potential who are not using a medically approved form of contraception.
Clinically significant disease or medical condition other than CF or CF-related conditions that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data. Patients with diabetes may participate if their disease is under good control prior to screening.

Trial locations and contacts

99 sites in 20 countries.

Country

City, postcode or hospital

99 sites in 20 countries

United States15 sites

205.438.01005 Boehringer Ingelheim Investigational Site
Charleston, South Carolina
205.438.01019 Boehringer Ingelheim Investigational Site
Cleveland, Ohio
205.438.01001 Boehringer Ingelheim Investigational Site
Detroit, Michigan
205.438.01007 Boehringer Ingelheim Investigational Site
Indianapolis, Indiana
205.438.01018 Boehringer Ingelheim Investigational Site
Jacksonville, Florida
205.438.01010 Boehringer Ingelheim Investigational Site
Manchester, New Hampshire
205.438.01012 Boehringer Ingelheim Investigational Site
Milwaukee, Wisconsin
205.438.01013 Boehringer Ingelheim Investigational Site
Oklahoma City, Oklahoma
205.438.01008 Boehringer Ingelheim Investigational Site
Orlando, Florida
205.438.01014 Boehringer Ingelheim Investigational Site
Orlando, Florida
205.438.01021 Boehringer Ingelheim Investigational Site
Orlando, Florida
205.438.01011 Boehringer Ingelheim Investigational Site
San Diego, California
205.438.01006 Boehringer Ingelheim Investigational Site
South Bend, Indiana
205.438.01003 Boehringer Ingelheim Investigational Site
Syracuse, New York
205.438.01004 Boehringer Ingelheim Investigational Site
Tuscon, Arizona

Other trials in United States

France14 sites

205.438.33010 Boehringer Ingelheim Investigational Site
Angers
205.438.33013 Boehringer Ingelheim Investigational Site
Bron
205.438.33002 Boehringer Ingelheim Investigational Site
Lille
205.438.33015 Boehringer Ingelheim Investigational Site
Lisieux
205.438.33003 Boehringer Ingelheim Investigational Site
Montpellier
205.438.33005 Boehringer Ingelheim Investigational Site
Nantes
205.438.33014 Boehringer Ingelheim Investigational Site
Nice
205.438.33001 Boehringer Ingelheim Investigational Site
Paris
205.438.33006 Boehringer Ingelheim Investigational Site
Paris
205.438.33007 Boehringer Ingelheim Investigational Site
Paris
205.438.33011 Boehringer Ingelheim Investigational Site
Rennes
205.438.33008 Boehringer Ingelheim Investigational Site
Roscoff
205.438.33004 Boehringer Ingelheim Investigational Site
Rouen
205.438.33009 Boehringer Ingelheim Investigational Site
Vannes

Other trials in France

Germany9 sites

205.438.49001 Boehringer Ingelheim Investigational Site
Bochum
205.438.49002 Boehringer Ingelheim Investigational Site
Frankfurt
205.438.49012 Boehringer Ingelheim Investigational Site
Frankfurt
205.438.49011 Boehringer Ingelheim Investigational Site
Frankfurt am Main
205.438.49006 Boehringer Ingelheim Investigational Site
Gerlingen
205.438.49007 Boehringer Ingelheim Investigational Site
Giessen
205.438.49005 Boehringer Ingelheim Investigational Site
Hamburg
205.438.49003 Boehringer Ingelheim Investigational Site
München
205.438.49008 Boehringer Ingelheim Investigational Site
Tübingen

Other trials in Germany

Canada6 sites

205.438.02005 Boehringer Ingelheim Investigational Site
Calgary, Alberta
205.438.02004 Boehringer Ingelheim Investigational Site
Halifax, Nova Scotia
205.438.02003 Boehringer Ingelheim Investigational Site
Hamilton, Ontario
205.438.02001 Boehringer Ingelheim Investigational Site
Sherbrooke, Quebec
205.438.02006 Boehringer Ingelheim Investigational Site
Toronto, Ontario
205.438.02007 Boehringer Ingelheim Investigational Site
Vancouver, British Columbia

Other trials in Canada

United Kingdom6 sites

205.438.44009 Boehringer Ingelheim Investigational Site
Brighton
205.438.44007 Boehringer Ingelheim Investigational Site
Cambridge
205.438.44004 Boehringer Ingelheim Investigational Site
Leeds
205.438.44005 Boehringer Ingelheim Investigational Site
Nottingham
205.438.44002 Boehringer Ingelheim Investigational Site
Plymouth
205.438.44003 Boehringer Ingelheim Investigational Site
Sheffield

Other trials in United Kingdom

Russia5 sites

205.438.07001 Boehringer Ingelheim Investigational Site
Moscow
205.438.07005 Boehringer Ingelheim Investigational Site
Moscow
205.438.07003 Boehringer Ingelheim Investigational Site
Saint Petersburg
205.438.07004 Boehringer Ingelheim Investigational Site
Voronezh
205.438.07002 Boehringer Ingelheim Investigational Site
Yaroslavl

Other trials in Russia

Australia4 sites

205.438.61001 Boehringer Ingelheim Investigational Site
Adelaide, South Australia
205.438.61003 Boehringer Ingelheim Investigational Site
Chermside, Queensland
205.438.61004 Boehringer Ingelheim Investigational Site
Herston, Queensland
205.438.61002 Boehringer Ingelheim Investigational Site
Subiaco, Western Australia

Other trials in Australia

Belgium4 sites

205.438.32002 Boehringer Ingelheim Investigational Site
Brussels
205.438.32004 Boehringer Ingelheim Investigational Site
Edegem
205.438.32003 Boehringer Ingelheim Investigational Site
Jette
205.438.32001 Boehringer Ingelheim Investigational Site
Leuven

Other trials in Belgium

Czechia4 sites

205.438.42002 Boehringer Ingelheim Investigational Site
Brno
205.438.42003 Boehringer Ingelheim Investigational Site
Brno
205.438.42004 Boehringer Ingelheim Investigational Site
Olomouc
205.438.42001 Boehringer Ingelheim Investigational Site
Prague

Other trials in Czechia

Israel4 sites

205.438.97003 Boehringer Ingelheim Investigational Site
Haifa
205.438.97001 Boehringer Ingelheim Investigational Site
Jerusalem
205.438.97002 Boehringer Ingelheim Investigational Site
Petah Tikva
205.438.97004 Boehringer Ingelheim Investigational Site
Tel HaShomer

Other trials in Israel

Portugal4 sites

205.438.35001 Boehringer Ingelheim Investigational Site
Lisbon
205.438.35002 Boehringer Ingelheim Investigational Site
Lisbon
205.438.35003 Boehringer Ingelheim Investigational Site
Porto
205.438.35004 Boehringer Ingelheim Investigational Site
Porto

Other trials in Portugal

Spain4 sites

205.438.34005 Boehringer Ingelheim Investigational Site
Barcelona
205.438.34001 Boehringer Ingelheim Investigational Site
Madrid
205.438.34002 Boehringer Ingelheim Investigational Site
Madrid
205.438.34004 Boehringer Ingelheim Investigational Site
Valencia

Other trials in Spain

Switzerland4 sites

205.438.41003 Boehringer Ingelheim Investigational Site
Basel
205.438.41004 Boehringer Ingelheim Investigational Site
Bern
205.438.41001 Boehringer Ingelheim Investigational Site
Zurich
205.438.41002 Boehringer Ingelheim Investigational Site
Zurich

Other trials in Switzerland

Hungary3 sites

205.438.36002 Boehringer Ingelheim Investigational Site
Budapest
205.438.36003 Boehringer Ingelheim Investigational Site
Mosdós
205.438.36004 Boehringer Ingelheim Investigational Site
Szeged

Other trials in Hungary

Italy3 sites

205.438.39001 Boehringer Ingelheim Investigational Site
Florence
205.438.39003 Boehringer Ingelheim Investigational Site
Genova
205.438.39002 Boehringer Ingelheim Investigational Site
Verona

Other trials in Italy

Poland3 sites

205.438.48001 Boehringer Ingelheim Investigational Site
Lodz
205.438.48002 Boehringer Ingelheim Investigational Site
Rabka-Zdrój
205.438.48003 Boehringer Ingelheim Investigational Site
Warsaw

Other trials in Poland

Slovakia3 sites

205.438.42102 Boehringer Ingelheim Investigational Site
Banská Bystrica
205.438.42101 Boehringer Ingelheim Investigational Site
Bratislava
205.438.42103 Boehringer Ingelheim Investigational Site
Košice

Other trials in Slovakia

Austria2 sites

205.438.43001 Boehringer Ingelheim Investigational Site
Innsbruck
205.438.43002 Boehringer Ingelheim Investigational Site
Salzburg

Other trials in Austria

Ireland1 site

205.438.35301 Boehringer Ingelheim Investigational Site
Dublin

Other trials in Ireland

South Africa1 site

205.438.27001 Boehringer Ingelheim Investigational Site
Cape Town

Other trials in South Africa

About this study

Official title: A Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis.

To date, there have been no formal clinical studies completed using tiotropium in CF patients. While there is a large body of evidence demonstrating the efficacy and safety of tiotropium in patients with Chronic Obstructive Pulmonary Disease (COPD), relatively little is known about its efficacy and safety in patients with a diagnosis of cystic fibrosis. Therefore, Boehringer Ingelheim proposed to profile the long acting anticholinergic tiotropium and to generate adequate clinical data for use as a bronchodilator in paediatric and adult CF. The phase III trial (205.438) is a part of the approved Paediatric Investigation Plan (PIP) agreed for Spiriva® Respimat® in Cystic Fibrosis.

Conditions: Cystic Fibrosis
Being tested: tiotropium Respimat® inhaler, Placebo Respimat® inhaler
Medical subject headings: Cystic Fibrosis

What participants receive

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

tiotropium Respimat® inhalerDrug
to evaluate safety and efficacy tiotropium delivered with Respimat® inhaler compared to placebo.
Placebo Respimat® inhalerDrug
patient to receive placebo matching active drug once daily

Study groups in NCT01179347
Study group	Role	What they receive
tiotropium	Experimental	2 inhalations once daily delivered with Respimat® inhaler Receives: Drug: tiotropium Respimat® inhaler
placebo	Placebo comparator	2 inhalations once daily delivered with Respimat® inhaler Receives: Drug: Placebo Respimat® inhaler

What is being measured

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

Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response
Mixed Model Repeated Measurement (MMRM) results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FEV1 AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).
Measured: 30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.
Trough FEV1 Response
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FEV1 was defined as the pre-dose FEV1 measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.
Measured: Baseline and 12 weeks

Secondary outcomes (5)

Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FVC AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).
Measured: 30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.
Trough FVC Response
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FCV was defined as the pre-dose FVC measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.
Measured: Baseline and 12 weeks
Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25-75) Response
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. FEF25-75 is also known as maximum mid-expiratory flow and was measured before bronchodilator (salbutamol) use. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.
Measured: Baseline and 12 weeks
Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment
Selected questions from the Respiratory and Systemic Symptoms Questionnaire (RSSQ), the investigator assessment of physical findings and pulmonary function, and the use of intravenous antibiotics as a concomitant therapy were used to determine if a cystic fibrosis-related pulmonary exacerbation had occurred.
Measured: 12 weeks
Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score
Different format of CFQ-R are used depending of the patients' age. Adolescent and adult format of CFQ-R is used for patients of 14 years and older, for younger children a parent version and a children format is used. In case parent and children questionnaires were filled out, the children questionnaire is taken into account. Scores were calculated for each domain of the CFQ-R which are presented separately. A score of 100 corresponds to the highest quality of life possible, whereas a score of 0 corresponds to the lowest quality of life possible. Increasing score indicates better health.
Measured: Baseline and 12 weeks

Timeline

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

Sep 2010Mar 2012

First posted11 Aug 2010 (estimated)
Study startSep 2010
Primary completionMar 2012

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 (1)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 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Enrolment: 464 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01179347
Sponsor's protocol ID: 205.438
Other IDs: 2010-019802-17
Status last verified: Oct 2013
First submitted: 10 Aug 2010
Last updated: 24 Dec 2013
Results posted: Yes, on ClinicalTrials.gov

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

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 24 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomised, Double-blind, Placebo-controlled Parallel-group Trial to Confirm the Efficacy After 12 Weeks and the Safety of Tiotropium 5 Mcg Administered Once Daily Via the Respimat® Device in Patients With Cystic Fibrosis.
ClinicalTrials.gov ID: NCT01179347
Acronym / sponsor ID: 205.438
Conditions: Cystic Fibrosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 464 participants (actual)
Lead sponsor: Boehringer IngelheimIndustry (pharma, biotech, devices)
Study start: Sep 2010
Primary completion: Mar 2012 (actual)
First posted: 11 Aug 2010 (estimated)
Results: Posted 26 Mar 2013

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: 2

Arm	Type	Receives
tiotropium	Experimental	Drug: tiotropium Respimat® inhaler2 inhalations once daily delivered with Respimat® inhaler
placebo	Placebo comparator	Drug: Placebo Respimat® inhaler2 inhalations once daily delivered with Respimat® inhaler

Who may qualify

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

Key inclusion criteria (10 listed)

Patients with a documented diagnosis of Cystic Fibrosis (CF) (positive sweat chloride >=60 mEq/liter, by pilocarpine iontophoresis) and/or a genotype with two identifiable mutations.
Male or female patients (children less than 12 years and adolescents >12 years).
Patients >=5 years of age must be able to perform acceptable spirometric maneuvers, according to the American Thoracic Society (ATS) standards.
Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) >25% of predicted values.
Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1.

Key exclusion criteria (7 listed)

Patients with a known hypersensitivity to study drug
Patients who have participated in another study with an Investigational drug within one month preceding the screening visit.
Patients who are currently participating in another trial. Observational studies are allowed. Permission should be obtained from sponsor of other study.
Patients with known relevant substance abuse, including alcohol or drug abuse.
Adolescent and adult female patients who are pregnant or lactating, including females who have a positive serum pregnancy test at screening.

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 Respimat® inhalerto evaluate safety and efficacy tiotropium delivered with Respimat® inhaler compared to placebo.	Drug	tiotropium
Placebo Respimat® inhalerpatient to receive placebo matching active drug once daily	Drug	placebo

Primary outcome

Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response
Time frame: 30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.
Mixed Model Repeated Measurement (MMRM) results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction. FEV1 AUC0-4h was normalised for time and was calculated using the trapezoidal rule divided by the observation time (4 h).
Trough FEV1 Response
Time frame: Baseline and 12 weeks
MMRM results. Response was defined as change from baseline in percent of predicted at the end of 12-week double-blind treatment period and is therefore expressed in percent of predicted. Trough FEV1 was defined as the pre-dose FEV1 measured just prior to the administration of randomised treatment. Means are adjusted for treatment, visit, treatment-by-visit interaction, age group (<= 11, >=12), baseline and baseline-by-visit interaction.

5 secondary outcomes

Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response
Time frame: 30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.
Trough FVC Response
Time frame: Baseline and 12 weeks
Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25-75) Response
Time frame: Baseline and 12 weeks
Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment
Time frame: 12 weeks
Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score
Time frame: Baseline and 12 weeks

Results and safety

Results posted to the registry on 26 Mar 2013, 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	155	147
Tio R5 qd	308	294

Primary outcome: Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response

Time frame: 30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.. Mean (Standard Error). Unit: Percent of predicted

Measure	Placebo n = 146	Tio R5 qd n = 292
Value	0.87 (0.80)	2.51 (0.57)

Placebo vs Tio R5 qd: Mean Difference (Final Values): 1.64 (95% CI -0.27 to 3.55), p = 0.092, Mixed Models Analysis

Population analysed: Full Analysis Set (FAS) with imputation reduced to patients with observed wash-out compliance. The FAS was defined as all patients in the treated set who had at least 1 baseline pulmonary function test (PFT) measurement and at least 1 post-baseline on-treatment PFT measurement. No patients \<5 years of age were included in the FAS.

Primary outcome: Trough FEV1 Response

Time frame: Baseline and 12 weeks. Mean (Standard Error). Unit: Percent of predicted

Measure	Placebo n = 144	Tio R5 qd n = 287
Value	0.72 (0.80)	2.12 (0.58)

Placebo vs Tio R5 qd: Mean Difference (Final Values): 1.40 (95% CI -0.50 to 3.30), p = 0.15, Mixed Models Analysis

5 secondary outcomes are reported in the full results.

Adverse events

Time frame: First administration of trial medication until 30 days after last administration of trial drug, for AE analyses over open-label period and over the study. Over the double-blind period, 30 days of wash-out is only used for premature discontinued patients.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Placebo Randomized Group Over the Double-Blind Period	13 of 155 (8.4%)	27 of 155 (17.4%)	Not reported
Tio 5mcg Randomized Group Over the Double-Blind Period	36 of 308 (11.7%)	63 of 308 (20.5%)	Not reported
Placebo Randomized Group Over the Open-Label Period	24 of 147 (16.3%)	56 of 147 (38.1%)	Not reported
Tio 5mcg Randomized Group Over the Study	62 of 308 (20.1%)	186 of 308 (60.4%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Dec 2013.
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.
Related InfoLink provided by the sponsor.
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

99 sites in 20 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing tiotropium Respimat® inhaler in people with Cystic Fibrosis, run by Boehringer Ingelheim at 99 sites in 20 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 10 inclusion and 7 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 24 Dec 2013. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 99 sites in United States, France, Germany, Canada, United Kingdom and 15 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 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?

Yes. Results are posted in the registry (first posted 26 Mar 2013). 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?

Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response (time frame: 30 minutes (min) before first dosing of study drug (defined as baseline), at 1 hour (h), 2 h , 3 h, and 4 h post dosing at day 1 and at 30 min before dosing, at 1 hour, 2 h , 3 h, and 4 h post dosing after 12 weeks.). 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 NCT01179347, which also lists 1 linked publication.

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 24 Dec 2013.