Please note that the copy function is not enabled for this field.
If you wish to
modify
existing outcomes, please copy and paste the current outcome text into the Update field.
LOGIN
CREATE ACCOUNT
LOGIN
CREATE ACCOUNT
MY TRIALS
REGISTER TRIAL
FAQs
HINTS AND TIPS
DEFINITIONS
Trial Review
The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this
information for consumers
Download to PDF
Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT00737100
Registration number
NCT00737100
Ethics application status
Date submitted
15/08/2008
Date registered
18/08/2008
Date last updated
16/05/2014
Titles & IDs
Public title
Safety and Efficacy of 12-wk Treatment With Two Doses of Tiotropium Respimat in Cystic Fibrosis
Query!
Scientific 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.
Query!
Secondary ID [1]
0
0
2008-001156-43
Query!
Secondary ID [2]
0
0
205.339
Query!
Universal Trial Number (UTN)
Query!
Trial acronym
Query!
Linked study record
Query!
Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
0
0
Query!
Condition category
Condition code
Human Genetics and Inherited Disorders
0
0
0
0
Query!
Cystic fibrosis
Query!
Respiratory
0
0
0
0
Query!
Other respiratory disorders / diseases
Query!
Oral and Gastrointestinal
0
0
0
0
Query!
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Connective tissue diseases
Query!
Inflammatory and Immune System
0
0
0
0
Query!
Other inflammatory or immune system disorders
Query!
Intervention/exposure
Study type
Interventional(has expanded access)
Query!
Description of intervention(s) / exposure
Treatment: Drugs - Placebo Respimat
Treatment: Drugs - Tiotropium bromide 5 mcg
Treatment: Drugs - tiotropium bromide-low dose-2.5mcg
Experimental: Tiotropium Respimat 2.5 mcg - patient to receive low dose tiotropium once daily
Experimental: Tiotropium Respimat 5 mcg - patient to receive high dose tiotropium once daily
Placebo comparator: Placebo Respimat - patient to receive placebo once daily
Treatment: Drugs: Placebo Respimat
patient to receive placebo matching active drug once daily
Treatment: Drugs: Tiotropium bromide 5 mcg
patient to recieve high dose tiotropium once daily
Treatment: Drugs: tiotropium bromide-low dose-2.5mcg
patient to receive low dose tiotropium once daily
Query!
Intervention code [1]
0
0
Treatment: Drugs
Query!
Comparator / control treatment
Query!
Control group
Query!
Outcomes
Primary outcome [1]
0
0
Percent Predicted FEV1 AUC0-4 Response at the End of Week 12
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline, Week 12
Query!
Primary outcome [2]
0
0
Percent Predicted FEV1 Trough Response at the End of Week 12
Query!
Assessment method [2]
0
0
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.
Query!
Timepoint [2]
0
0
Baseline, Week 12
Query!
Secondary outcome [1]
0
0
Percent Predicted FVC AUC0-4 Response at the End of Week 12
Query!
Assessment method [1]
0
0
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.
Query!
Timepoint [1]
0
0
Baseline, Week 12
Query!
Secondary outcome [2]
0
0
Percent Predicted FVC Trough Response at the End of Week 12
Query!
Assessment method [2]
0
0
Change from baseline in percent predicted trough Forced Vital Capacity (FVC). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Query!
Timepoint [2]
0
0
Baseline, Week 12
Query!
Secondary outcome [3]
0
0
Pre-bronchodilator FEF25-75 Percent Predicted at the End of Week 12
Query!
Assessment method [3]
0
0
Forced Expiratory Flow at 25-75% of vital capacity (FEF25-75). Calculated as percent predicted at week 12 minus percent predicted at baseline.
Query!
Timepoint [3]
0
0
Baseline, Week 12
Query!
Secondary outcome [4]
0
0
Change From Baseline in Residual Volume/Total Lung Capacity (RV/TLC) at the End of Week 12
Query!
Assessment method [4]
0
0
Change from baseline in static lung hyperinflation as measured by RV/TLC. Calculated as percent predicted at week 12 minus percent predicted at baseline.
Query!
Timepoint [4]
0
0
Baseline, Week 12
Query!
Secondary outcome [5]
0
0
Respiratory and Systemic Symptoms Questionnaire (RSSQ)
Query!
Assessment method [5]
0
0
Outcome measure description: The RSSQ questionnaire is used to determine the presence or absence of an exacerbation during the recall period.
Query!
Timepoint [5]
0
0
12 weeks
Query!
Secondary outcome [6]
0
0
Change From Baseline in CFQ Scores - Adult Group
Query!
Assessment method [6]
0
0
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.
Query!
Timepoint [6]
0
0
12 weeks
Query!
Secondary outcome [7]
0
0
Change From Baseline in CFQ Scores - Adolescents Group
Query!
Assessment method [7]
0
0
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.
Query!
Timepoint [7]
0
0
12 weeks
Query!
Secondary outcome [8]
0
0
Change From Baseline in CFQ Scores - Parent Questionnaire
Query!
Assessment method [8]
0
0
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.
Query!
Timepoint [8]
0
0
12 weeks
Query!
Secondary outcome [9]
0
0
Amount of Tiotropium Eliminated in Urine From 0 to 4 Hours at Steady State (Ae0-4,ss)
Query!
Assessment method [9]
0
0
Ae0-4,ss represents the amount of tiotropium that is eliminated in urine from time 0 to 4 hours at steady state
Query!
Timepoint [9]
0
0
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Query!
Secondary outcome [10]
0
0
Maximum Measured Concentration at Steady State (Cmax,ss)
Query!
Assessment method [10]
0
0
Cmax,ss represents the maximum measured concentration of tiotropium in plasma at steady state.
Query!
Timepoint [10]
0
0
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Query!
Secondary outcome [11]
0
0
Time From Dosing to the Maximum Concentration (Tmax,ss)
Query!
Assessment method [11]
0
0
Tmax,ss represents the time from dosing to the maximum concentration of tiotropium in plasma
Query!
Timepoint [11]
0
0
pre-dose, and 5 minutes (min), 20 min, 1 hour (h), and 2 h post-dose
Query!
Secondary outcome [12]
0
0
Clinical Relevant Abnormalities for Vital Signs and Laboratory Evaluation
Query!
Assessment method [12]
0
0
Clinical Relevant Abnormalities for Vital Signs and Laboratory evaluation. Any new or clinically relevant worsening of baseline conditions was reported as Adverse Event.
Query!
Timepoint [12]
0
0
From first drug administration until 30 days after last drug administration (up to 121 days)
Query!
Eligibility
Key inclusion criteria
Inclusion criteria:
1. Male or female patients
2. Diagnosis of Cystic Fibrosis (positive sweat chloride test or two identifiable mutations)
3. Pre-bronchodilator FEV1 greater/equal 25% of predicted values
Query!
Minimum age
No limit
Query!
Query!
Maximum age
No limit
Query!
Query!
Sex
Both males and females
Query!
Can healthy volunteers participate?
No
Query!
Key exclusion criteria
Exclusion criteria:
1. Significant history of allergy/hypersensitivity
2. Hypersensitivity to study drug
3. Participation in another trial
4. Female patients who are pregnant or lactating
5. Female patients of childbearing potential
6. Patients who have started a new medication for CF within 4 weeks of screening
7. Patients with known substance abuse
8. Clinically significant disease other than CF
Query!
Study design
Purpose of the study
Treatment
Query!
Allocation to intervention
Randomised controlled trial
Query!
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Query!
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Query!
Masking / blinding
Blinded (masking used)
Query!
Who is / are masked / blinded?
Query!
Query!
Query!
Query!
Intervention assignment
Parallel
Query!
Other design features
Query!
Phase
Phase 2
Query!
Type of endpoint/s
Query!
Statistical methods / analysis
Query!
Recruitment
Recruitment status
Completed
Query!
Data analysis
Query!
Reason for early stopping/withdrawal
Query!
Other reasons
Query!
Date of first participant enrolment
Anticipated
Query!
Actual
1/09/2008
Query!
Date of last participant enrolment
Anticipated
Query!
Actual
Query!
Date of last data collection
Anticipated
Query!
Actual
Query!
Sample size
Target
Query!
Accrual to date
Query!
Final
510
Query!
Recruitment in Australia
Recruitment state(s)
NSW,SA,WA
Query!
Recruitment hospital [1]
0
0
205.339.100 Boehringer Ingelheim Investigational Site - Westmead
Query!
Recruitment hospital [2]
0
0
205.339.101 Boehringer Ingelheim Investigational Site - Westmead
Query!
Recruitment hospital [3]
0
0
205.339.103 Boehringer Ingelheim Investigational Site - Adelaide
Query!
Recruitment hospital [4]
0
0
205.339.104 Boehringer Ingelheim Investigational Site - Subiaco
Query!
Recruitment postcode(s) [1]
0
0
- Westmead
Query!
Recruitment postcode(s) [2]
0
0
- Adelaide
Query!
Recruitment postcode(s) [3]
0
0
- Subiaco
Query!
Recruitment outside Australia
Country [1]
0
0
United States of America
Query!
State/province [1]
0
0
Arizona
Query!
Country [2]
0
0
United States of America
Query!
State/province [2]
0
0
California
Query!
Country [3]
0
0
United States of America
Query!
State/province [3]
0
0
Florida
Query!
Country [4]
0
0
United States of America
Query!
State/province [4]
0
0
Indiana
Query!
Country [5]
0
0
United States of America
Query!
State/province [5]
0
0
Iowa
Query!
Country [6]
0
0
United States of America
Query!
State/province [6]
0
0
Michigan
Query!
Country [7]
0
0
United States of America
Query!
State/province [7]
0
0
New Hampshire
Query!
Country [8]
0
0
United States of America
Query!
State/province [8]
0
0
New Jersey
Query!
Country [9]
0
0
United States of America
Query!
State/province [9]
0
0
New York
Query!
Country [10]
0
0
United States of America
Query!
State/province [10]
0
0
Ohio
Query!
Country [11]
0
0
United States of America
Query!
State/province [11]
0
0
Oklahoma
Query!
Country [12]
0
0
United States of America
Query!
State/province [12]
0
0
South Carolina
Query!
Country [13]
0
0
United States of America
Query!
State/province [13]
0
0
Texas
Query!
Country [14]
0
0
United States of America
Query!
State/province [14]
0
0
Utah
Query!
Country [15]
0
0
United States of America
Query!
State/province [15]
0
0
Vermont
Query!
Country [16]
0
0
United States of America
Query!
State/province [16]
0
0
Virginia
Query!
Country [17]
0
0
United States of America
Query!
State/province [17]
0
0
Wisconsin
Query!
Country [18]
0
0
Belgium
Query!
State/province [18]
0
0
Bruxelles
Query!
Country [19]
0
0
Belgium
Query!
State/province [19]
0
0
Jette
Query!
Country [20]
0
0
Belgium
Query!
State/province [20]
0
0
Leuven
Query!
Country [21]
0
0
France
Query!
State/province [21]
0
0
Amiens
Query!
Country [22]
0
0
France
Query!
State/province [22]
0
0
Angers
Query!
Country [23]
0
0
France
Query!
State/province [23]
0
0
BRON Cedex
Query!
Country [24]
0
0
France
Query!
State/province [24]
0
0
Lille Cedex
Query!
Country [25]
0
0
France
Query!
State/province [25]
0
0
Lille
Query!
Country [26]
0
0
France
Query!
State/province [26]
0
0
Lisieux
Query!
Country [27]
0
0
France
Query!
State/province [27]
0
0
Montpellier
Query!
Country [28]
0
0
France
Query!
State/province [28]
0
0
Nantes
Query!
Country [29]
0
0
France
Query!
State/province [29]
0
0
Paris Cedex 14
Query!
Country [30]
0
0
France
Query!
State/province [30]
0
0
Paris
Query!
Country [31]
0
0
France
Query!
State/province [31]
0
0
Rennes
Query!
Country [32]
0
0
France
Query!
State/province [32]
0
0
Roscoff Cedex
Query!
Country [33]
0
0
France
Query!
State/province [33]
0
0
Rouen cedex
Query!
Country [34]
0
0
France
Query!
State/province [34]
0
0
Vandoeuvre les Nancy
Query!
Country [35]
0
0
France
Query!
State/province [35]
0
0
Vannes
Query!
Country [36]
0
0
Germany
Query!
State/province [36]
0
0
Erlangen
Query!
Country [37]
0
0
Germany
Query!
State/province [37]
0
0
Frankfurt/Main
Query!
Country [38]
0
0
Germany
Query!
State/province [38]
0
0
Frankfurt
Query!
Country [39]
0
0
Germany
Query!
State/province [39]
0
0
Freiburg
Query!
Country [40]
0
0
Germany
Query!
State/province [40]
0
0
Gerlingen
Query!
Country [41]
0
0
Germany
Query!
State/province [41]
0
0
Hamburg
Query!
Country [42]
0
0
Germany
Query!
State/province [42]
0
0
Hannover
Query!
Country [43]
0
0
Germany
Query!
State/province [43]
0
0
Heidelberg
Query!
Country [44]
0
0
Germany
Query!
State/province [44]
0
0
München
Query!
Country [45]
0
0
Germany
Query!
State/province [45]
0
0
Tübingen
Query!
Country [46]
0
0
Italy
Query!
State/province [46]
0
0
Ancona
Query!
Country [47]
0
0
Italy
Query!
State/province [47]
0
0
Firenze
Query!
Country [48]
0
0
Italy
Query!
State/province [48]
0
0
Genova
Query!
Country [49]
0
0
Netherlands
Query!
State/province [49]
0
0
Groesbeek
Query!
Country [50]
0
0
Netherlands
Query!
State/province [50]
0
0
Rotterdam
Query!
Country [51]
0
0
New Zealand
Query!
State/province [51]
0
0
Grafton / Auckland
Query!
Country [52]
0
0
New Zealand
Query!
State/province [52]
0
0
Hamilton
Query!
Country [53]
0
0
Portugal
Query!
State/province [53]
0
0
Lisboa
Query!
Country [54]
0
0
Portugal
Query!
State/province [54]
0
0
Porto
Query!
Country [55]
0
0
Russian Federation
Query!
State/province [55]
0
0
Moscow
Query!
Country [56]
0
0
Russian Federation
Query!
State/province [56]
0
0
Rostov-on-Don
Query!
Country [57]
0
0
Russian Federation
Query!
State/province [57]
0
0
St. Petersburg
Query!
Country [58]
0
0
Russian Federation
Query!
State/province [58]
0
0
Voronezh
Query!
Country [59]
0
0
Russian Federation
Query!
State/province [59]
0
0
Yaroslavl
Query!
Country [60]
0
0
United Kingdom
Query!
State/province [60]
0
0
Belfast
Query!
Country [61]
0
0
United Kingdom
Query!
State/province [61]
0
0
Birmingham
Query!
Country [62]
0
0
United Kingdom
Query!
State/province [62]
0
0
Boston
Query!
Country [63]
0
0
United Kingdom
Query!
State/province [63]
0
0
Leeds
Query!
Country [64]
0
0
United Kingdom
Query!
State/province [64]
0
0
Lincoln
Query!
Country [65]
0
0
United Kingdom
Query!
State/province [65]
0
0
Liverpool
Query!
Country [66]
0
0
United Kingdom
Query!
State/province [66]
0
0
Nottingham
Query!
Country [67]
0
0
United Kingdom
Query!
State/province [67]
0
0
Oxford
Query!
Country [68]
0
0
United Kingdom
Query!
State/province [68]
0
0
Plymouth
Query!
Country [69]
0
0
United Kingdom
Query!
State/province [69]
0
0
Sheffield
Query!
Country [70]
0
0
United Kingdom
Query!
State/province [70]
0
0
Wolverhampton
Query!
Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Query!
Name
Boehringer Ingelheim
Query!
Address
Query!
Country
Query!
Ethics approval
Ethics application status
Query!
Summary
Brief 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. The selection of the optimal dose will be based on bronchodilator efficacy, safety evaluations and pharmacokinetic evaluations
Query!
Trial website
https://clinicaltrials.gov/study/NCT00737100
Query!
Trial related presentations / 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. 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.
Query!
Public notes
Query!
Contacts
Principal investigator
Name
0
0
Boehringer Ingelheim
Query!
Address
0
0
Boehringer Ingelheim
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for public queries
Name
0
0
Query!
Address
0
0
Query!
Country
0
0
Query!
Phone
0
0
Query!
Fax
0
0
Query!
Email
0
0
Query!
Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT00737100
Download to PDF