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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT01179347
Registration number
NCT01179347
Ethics application status
Date submitted
10/08/2010
Date registered
11/08/2010
Date last updated
24/12/2013
Titles & IDs
Public title
Tiotropium Bromide in Cystic Fibrosis
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Scientific 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.
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Secondary ID [1]
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2010-019802-17
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Secondary ID [2]
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205.438
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Cystic Fibrosis
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Condition category
Condition code
Human Genetics and Inherited Disorders
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Cystic fibrosis
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Respiratory
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0
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0
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Other respiratory disorders / diseases
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Oral and Gastrointestinal
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0
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0
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Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
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Inflammatory and Immune System
0
0
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0
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Connective tissue diseases
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Inflammatory and Immune System
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0
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0
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Other inflammatory or immune system disorders
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - tiotropium Respimat® inhaler
Treatment: Drugs - Placebo Respimat® inhaler
Experimental: tiotropium - 2 inhalations once daily delivered with Respimat® inhaler
Placebo Comparator: placebo - 2 inhalations once daily delivered with Respimat® inhaler
Treatment: Drugs: tiotropium Respimat® inhaler
to evaluate safety and efficacy tiotropium delivered with Respimat® inhaler compared to placebo.
Treatment: Drugs: Placebo Respimat® inhaler
patient to receive placebo matching active drug once daily
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Forced Expiratory Volume in 1 Second (FEV1) Area Under the Curve 0-4 Hours (AUC0-4h) Response
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Assessment method [1]
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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).
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Timepoint [1]
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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.
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Primary outcome [2]
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Trough FEV1 Response
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and 12 weeks
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Secondary outcome [1]
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Forced Vital Capacity (FVC) Area Under the Curve 0-4 Hours (AUC0-4h) Response
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Assessment method [1]
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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).
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Timepoint [1]
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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.
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Secondary outcome [2]
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Trough FVC Response
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Assessment method [2]
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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.
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Timepoint [2]
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Baseline and 12 weeks
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Secondary outcome [3]
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Pre-bronchodilator Forced Expiratory Flow Between 25 Percent and 75 Percent of the FVC (FEF25-75) Response
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Assessment method [3]
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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.
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Timepoint [3]
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Baseline and 12 weeks
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Secondary outcome [4]
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Percentage of Participants With at Least 1 Pulmonary Exacerbation During Double-blind Treatment
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Assessment method [4]
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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.
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Timepoint [4]
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12 weeks
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Secondary outcome [5]
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Change From Baseline in Revised Cystic Fibrosis Questionnaire (CFQ-R) Score
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Assessment method [5]
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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.
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Timepoint [5]
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Baseline and 12 weeks
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Eligibility
Key inclusion criteria
Inclusion criteria:
1. 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.
2. Male or female patients (children less than 12 years and adolescents >12 years).
3. Patients >=5 years of age must be able to perform acceptable spirometric maneuvers,
according to the American Thoracic Society (ATS) standards.
4. Pre-bronchodilator Forced Expiratory Volume in One Second (FEV1) >25% of predicted
values.
5. Pre-bronchodilator FEV1 at Visit 2 must be within 15% of FEV1 at Visit 1.
6. 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.
7. The patient or the patient's legally acceptable representative must be able to give
informed consent.
8. 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.
9. Patients who are on daily inhaled antibiotic use must be stabilized for at least 6
weeks prior to Visit 1 (screening).
10. Patients having previously participated in study 205.339 can also be selected.
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Minimum age
No limit
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Exclusion criteria:
1. Patients with a known hypersensitivity to study drug
2. Patients who have participated in another study with an Investigational drug within
one month preceding the screening visit.
3. Patients who are currently participating in another trial. Observational studies are
allowed. Permission should be obtained from sponsor of other study.
4. Patients with known relevant substance abuse, including alcohol or drug abuse.
5. Adolescent and adult female patients who are pregnant or lactating, including females
who have a positive serum pregnancy test at screening.
6. Female patients of child bearing potential who are not using a medically approved form
of contraception.
7. 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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 3
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
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Sample size
Target
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Accrual to date
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Final
464
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Recruitment in Australia
Recruitment state(s)
QLD,SA,WA
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Recruitment hospital [1]
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205.438.61003 Boehringer Ingelheim Investigational Site - Chermside
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Recruitment hospital [2]
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205.438.61004 Boehringer Ingelheim Investigational Site - Herston
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Recruitment hospital [3]
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205.438.61001 Boehringer Ingelheim Investigational Site - Adelaide
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Recruitment hospital [4]
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205.438.61002 Boehringer Ingelheim Investigational Site - Subiaco
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Recruitment postcode(s) [1]
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- Chermside
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Recruitment postcode(s) [2]
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- Herston
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Recruitment postcode(s) [3]
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- Adelaide
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Recruitment postcode(s) [4]
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- Subiaco
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Recruitment outside Australia
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Arizona
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Sheffield
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Boehringer Ingelheim
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Address
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Ethics approval
Ethics application status
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Summary
Brief summary
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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT01179347
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Boehringer Ingelheim
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Address
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Boehringer Ingelheim
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT01179347
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