Trial · NCT00737100

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

NCT00737100, Phase 2, Completed, Boehringer Ingelheim; results first posted 2011-04-13

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis. Trials, record NCT00737100. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00737100

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
NCT number: NCT00737100
Status: Completed
Phases: Phase 2
Enrollment: 510 participants, actual
Lead sponsor: Boehringer Ingelheim
Conditions: Cystic Fibrosis
Interventions: Placebo Respimat, Tiotropium bromide 5 mcg, tiotropium bromide-low dose-2.5mcg
First posted: 2008-08-18
Last updated: 2014-05-16
Other registries' IDs: eudract:2008-001156-43
Results first posted: 2011-04-13

Source ClinicalTrials.gov

Registered outcomes14

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Percent Predicted FEV1 AUC0-4 Response at the End of Week 12	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.
Primary	Percent Predicted FEV1 Trough Response at the End of Week 12	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.
Secondary	Percent Predicted FVC AUC0-4 Response at the End of Week 12	Baseline, 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.
Secondary	Percent Predicted FVC Trough Response at the End of Week 12	Baseline, 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.
Secondary	Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12	Baseline, 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.
Secondary	Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12	Baseline, 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.
Secondary	Respiratory and Systemic Symptoms Questionnaire (RSSQ)	12 weeks	Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.
Secondary	Change From Baseline in CFQ Scores - Adult Group	12 weeks	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.
Secondary	Change From Baseline in CFQ Scores - Adolescents Group	12 weeks	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.
Secondary	Change From Baseline in CFQ Scores - Parent Questionnaire	12 weeks	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.

1 to 10 of 14Source ClinicalTrials.gov

See all 14 registered outcomes

Outcomes14

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Percent Predicted FEV1 AUC0-4 Response at the End of Week 12	Baseline, Week 12	Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement	Percentage change	LEAST_SQUARES_MEAN
PRIMARY	Percent Predicted FEV1 Trough Response at the End of Week 12	Baseline, Week 12	Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement	Percentage change	LEAST_SQUARES_MEAN
SECONDARY	Percent Predicted FVC AUC0-4 Response at the End of Week 12	Baseline, Week 12	Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement	Percentage change	LEAST_SQUARES_MEAN
SECONDARY	Percent Predicted FVC Trough Response at the End of Week 12	Baseline, Week 12	Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement	Percentage change	LEAST_SQUARES_MEAN
SECONDARY	Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12	Baseline, Week 12	Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement	Percentage change	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12	Baseline, Week 12	Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement	Percentage change	LEAST_SQUARES_MEAN
SECONDARY	Respiratory and Systemic Symptoms Questionnaire (RSSQ)	12 weeks	Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement	Participants	NUMBER
SECONDARY	Change From Baseline in CFQ Scores - Adult Group	12 weeks	Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement	units on a scale	MEAN
SECONDARY	Change From Baseline in CFQ Scores - Adolescents Group	12 weeks	Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement	units on a scale	MEAN
SECONDARY	Change From Baseline in CFQ Scores - Parent Questionnaire	12 weeks	Full Analysis Set (FAS) includes all participants having a baseline measurement and at least one post-dose measurement	units on a scale	MEAN

1 to 10 of 14Source ClinicalTrials.gov

See all 14 outcomes

Results by group150

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Percent Predicted FEV1 AUC0-4 Response at the End of Week 12	Placebo	-1.74	Standard Error 0.65	Percentage change
Percent Predicted FEV1 AUC0-4 Response at the End of Week 12	Tiotropium Respimat 2.5 Micrograms	1.20	Standard Error 0.66	Percentage change
Percent Predicted FEV1 AUC0-4 Response at the End of Week 12	Tiotropium Respimat 5 Micrograms	1.65	Standard Error 0.63	Percentage change
Percent Predicted FEV1 Trough Response at the End of Week 12	Placebo	-1.44	Standard Error 0.71	Percentage change
Percent Predicted FEV1 Trough Response at the End of Week 12	Tiotropium Respimat 2.5 Micrograms	0.81	Standard Error 0.71	Percentage change
Percent Predicted FEV1 Trough Response at the End of Week 12	Tiotropium Respimat 5 Micrograms	0.78	Standard Error 0.69	Percentage change
Percent Predicted FVC AUC0-4 Response at the End of Week 12	Placebo	-1.30	Standard Error 0.74	Percentage change
Percent Predicted FVC AUC0-4 Response at the End of Week 12	Tiotropium Respimat 2.5 Micrograms	0.53	Standard Error 0.74	Percentage change
Percent Predicted FVC AUC0-4 Response at the End of Week 12	Tiotropium Respimat 5 Micrograms	1.81	Standard Error 0.72	Percentage change
Percent Predicted FVC Trough Response at the End of Week 12	Placebo	-0.39	Standard Error 0.73	Percentage change

1 to 10 of 150Source ClinicalTrials.gov

See all 150 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	168
Overall Study	STARTED	Tiotropium Respimat 2.5 Micrograms	166
Overall Study	STARTED	Tiotropium Respimat 5 Micrograms	176
Overall Study	COMPLETED	Placebo	161
Overall Study	COMPLETED	Tiotropium Respimat 2.5 Micrograms	159
Overall Study	COMPLETED	Tiotropium Respimat 5 Micrograms	169
Overall Study	NOT COMPLETED	Placebo	7
Overall Study	NOT COMPLETED	Tiotropium Respimat 2.5 Micrograms	7
Overall Study	NOT COMPLETED	Tiotropium Respimat 5 Micrograms	7

Source ClinicalTrials.gov

Adverse events186

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk
other	Cystic fibrosis	Congenital, familial and genetic disorders	Placebo	12	168
other	Cystic fibrosis	Congenital, familial and genetic disorders	Tiotropium Respimat 2.5 Micrograms	15	166
other	Cystic fibrosis	Congenital, familial and genetic disorders	Tiotropium Respimat 5 Micrograms	17	176
other	Abdominal pain	Gastrointestinal disorders	Placebo	10	168
other	Abdominal pain	Gastrointestinal disorders	Tiotropium Respimat 2.5 Micrograms	13	166
other	Abdominal pain	Gastrointestinal disorders	Tiotropium Respimat 5 Micrograms	9	176
other	Pyrexia	General disorders	Placebo	17	168
other	Pyrexia	General disorders	Tiotropium Respimat 2.5 Micrograms	9	166
other	Pyrexia	General disorders	Tiotropium Respimat 5 Micrograms	18	176
other	Bronchitis	Infections and infestations	Placebo	7	168

1 to 10 of 186Source ClinicalTrials.gov

See all 186 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Tiotropium Respimat 2.5 Micrograms
Total, all-cause mortality	Tiotropium Respimat 5 Micrograms
Total, other adverse events	Placebo	87	168
Total, other adverse events	Tiotropium Respimat 2.5 Micrograms	95	166
Total, other adverse events	Tiotropium Respimat 5 Micrograms	110	176
Total, serious adverse events	Placebo	21	168
Total, serious adverse events	Tiotropium Respimat 2.5 Micrograms	28	166
Total, serious adverse events	Tiotropium Respimat 5 Micrograms	21	176

Source ClinicalTrials.gov

Papers2

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
25188297	DERIVED	PubMed
25819269	DERIVED	PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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