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NCT01179347 Clinical Trial

Tiotropium Bromide in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01179347
Other study ID # 205.438
Secondary ID 2010-019802-17
Status Completed
Phase Phase 3
First received August 10, 2010
Last updated November 27, 2013
Start date September 2010

Study information
Verified date October 2013
Source Boehringer Ingelheim
Contact n/a
Is FDA regulated No
Health authority Australia: Dept of Health and Ageing Therapeutic Goods AdminAustria: Federal Office for Safety in Health CareBelgium:Canada: Health CanadaCzech Republic: State Institute for Drug ControlFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesHungary: National Institute of PharmacyIreland: Irish Medicines BoardIsrael: Israeli Health Ministry Pharmaceutical AdministrationItaly: Ethics CommitteePoland: Registration Medicinal Product Medical Device Biocidal ProductPortugal: National Pharmacy and Medicines InstituteRussia: Pharmacological Committee, Ministry of HealthSlovakia: State Institute for Drug ControlSouth Africa: Medicines Control CouncilSpain: Spanish Agency of MedicinesSwitzerland: SwissmedicUnited Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 464
Est. completion date
Est. primary completion date March 2012
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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.

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

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

Locations
Country Name City State
Australia 205.438.61001 Boehringer Ingelheim Investigational Site Adelaide South Australia
Australia 205.438.61003 Boehringer Ingelheim Investigational Site Chermside Queensland
Australia 205.438.61004 Boehringer Ingelheim Investigational Site Herston Queensland
Australia 205.438.61002 Boehringer Ingelheim Investigational Site Subiaco Western Australia
Austria 205.438.43001 Boehringer Ingelheim Investigational Site Innsbruck
Austria 205.438.43002 Boehringer Ingelheim Investigational Site Salzburg
Belgium 205.438.32002 Boehringer Ingelheim Investigational Site Bruxelles
Belgium 205.438.32004 Boehringer Ingelheim Investigational Site Edegem
Belgium 205.438.32003 Boehringer Ingelheim Investigational Site Jette
Belgium 205.438.32001 Boehringer Ingelheim Investigational Site Leuven
Canada 205.438.02005 Boehringer Ingelheim Investigational Site Calgary Alberta
Canada 205.438.02004 Boehringer Ingelheim Investigational Site Halifax Nova Scotia
Canada 205.438.02003 Boehringer Ingelheim Investigational Site Hamilton Ontario
Canada 205.438.02001 Boehringer Ingelheim Investigational Site Sherbrooke Quebec
Canada 205.438.02006 Boehringer Ingelheim Investigational Site Toronto Ontario
Canada 205.438.02007 Boehringer Ingelheim Investigational Site Vancouver British Columbia
Czech Republic 205.438.42002 Boehringer Ingelheim Investigational Site Brno
Czech Republic 205.438.42003 Boehringer Ingelheim Investigational Site Brno
Czech Republic 205.438.42004 Boehringer Ingelheim Investigational Site Olomouc
Czech Republic 205.438.42001 Boehringer Ingelheim Investigational Site Prague 5
France 205.438.33010 Boehringer Ingelheim Investigational Site Angers
France 205.438.33013 Boehringer Ingelheim Investigational Site BRON Cedex
France 205.438.33002 Boehringer Ingelheim Investigational Site Lille Cedex
France 205.438.33015 Boehringer Ingelheim Investigational Site Lisieux
France 205.438.33003 Boehringer Ingelheim Investigational Site Montpellier
France 205.438.33005 Boehringer Ingelheim Investigational Site Nantes
France 205.438.33014 Boehringer Ingelheim Investigational Site Nice Cedex 1
France 205.438.33001 Boehringer Ingelheim Investigational Site Paris
France 205.438.33006 Boehringer Ingelheim Investigational Site Paris
France 205.438.33007 Boehringer Ingelheim Investigational Site Paris
France 205.438.33011 Boehringer Ingelheim Investigational Site Rennes
France 205.438.33008 Boehringer Ingelheim Investigational Site Roscoff Cedex
France 205.438.33004 Boehringer Ingelheim Investigational Site Rouen cedex
France 205.438.33009 Boehringer Ingelheim Investigational Site Vannes
Germany 205.438.49001 Boehringer Ingelheim Investigational Site Bochum
Germany 205.438.49002 Boehringer Ingelheim Investigational Site Frankfurt
Germany 205.438.49012 Boehringer Ingelheim Investigational Site Frankfurt
Germany 205.438.49011 Boehringer Ingelheim Investigational Site Frankfurt/Main
Germany 205.438.49006 Boehringer Ingelheim Investigational Site Gerlingen
Germany 205.438.49007 Boehringer Ingelheim Investigational Site Gießen
Germany 205.438.49005 Boehringer Ingelheim Investigational Site Hamburg
Germany 205.438.49003 Boehringer Ingelheim Investigational Site München
Germany 205.438.49008 Boehringer Ingelheim Investigational Site Tübingen
Hungary 205.438.36002 Boehringer Ingelheim Investigational Site Budapest
Hungary 205.438.36003 Boehringer Ingelheim Investigational Site Mosdos
Hungary 205.438.36004 Boehringer Ingelheim Investigational Site Szeged
Ireland 205.438.35301 Boehringer Ingelheim Investigational Site Dublin 12
Israel 205.438.97003 Boehringer Ingelheim Investigational Site Haifa
Israel 205.438.97001 Boehringer Ingelheim Investigational Site Jerusalem
Israel 205.438.97002 Boehringer Ingelheim Investigational Site Petach Tikva
Israel 205.438.97004 Boehringer Ingelheim Investigational Site Tel Hashomer
Italy 205.438.39001 Boehringer Ingelheim Investigational Site Firenze
Italy 205.438.39003 Boehringer Ingelheim Investigational Site Genova
Italy 205.438.39002 Boehringer Ingelheim Investigational Site Verona
Poland 205.438.48001 Boehringer Ingelheim Investigational Site Lodz
Poland 205.438.48002 Boehringer Ingelheim Investigational Site Rabka Zdroj
Poland 205.438.48003 Boehringer Ingelheim Investigational Site Warszawa
Portugal 205.438.35001 Boehringer Ingelheim Investigational Site Lisboa
Portugal 205.438.35002 Boehringer Ingelheim Investigational Site Lisboa
Portugal 205.438.35003 Boehringer Ingelheim Investigational Site Porto
Portugal 205.438.35004 Boehringer Ingelheim Investigational Site Porto
Russian Federation 205.438.07001 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 205.438.07005 Boehringer Ingelheim Investigational Site Moscow
Russian Federation 205.438.07003 Boehringer Ingelheim Investigational Site St. Petersburg
Russian Federation 205.438.07004 Boehringer Ingelheim Investigational Site Voronezh
Russian Federation 205.438.07002 Boehringer Ingelheim Investigational Site Yaroslavl
Slovakia 205.438.42102 Boehringer Ingelheim Investigational Site Banska Bystrica
Slovakia 205.438.42101 Boehringer Ingelheim Investigational Site Bratislava
Slovakia 205.438.42103 Boehringer Ingelheim Investigational Site Kosice
South Africa 205.438.27001 Boehringer Ingelheim Investigational Site Cape Town
Spain 205.438.34005 Boehringer Ingelheim Investigational Site Barcelona
Spain 205.438.34001 Boehringer Ingelheim Investigational Site Madrid
Spain 205.438.34002 Boehringer Ingelheim Investigational Site Madrid
Spain 205.438.34004 Boehringer Ingelheim Investigational Site Valencia
Switzerland 205.438.41003 Boehringer Ingelheim Investigational Site Basel
Switzerland 205.438.41004 Boehringer Ingelheim Investigational Site Bern 4
Switzerland 205.438.41001 Boehringer Ingelheim Investigational Site Zürich
Switzerland 205.438.41002 Boehringer Ingelheim Investigational Site Zürich
United Kingdom 205.438.44009 Boehringer Ingelheim Investigational Site Brighton
United Kingdom 205.438.44007 Boehringer Ingelheim Investigational Site Cambridge
United Kingdom 205.438.44004 Boehringer Ingelheim Investigational Site Leeds
United Kingdom 205.438.44005 Boehringer Ingelheim Investigational Site Nottingham
United Kingdom 205.438.44002 Boehringer Ingelheim Investigational Site Plymouth
United Kingdom 205.438.44003 Boehringer Ingelheim Investigational Site Sheffield
United States 205.438.01005 Boehringer Ingelheim Investigational Site Charleston South Carolina
United States 205.438.01019 Boehringer Ingelheim Investigational Site Cleveland Ohio
United States 205.438.01001 Boehringer Ingelheim Investigational Site Detroit Michigan
United States 205.438.01007 Boehringer Ingelheim Investigational Site Indianapolis Indiana
United States 205.438.01018 Boehringer Ingelheim Investigational Site Jacksonville Florida
United States 205.438.01010 Boehringer Ingelheim Investigational Site Manchester New Hampshire
United States 205.438.01012 Boehringer Ingelheim Investigational Site Milwaukee Wisconsin
United States 205.438.01013 Boehringer Ingelheim Investigational Site Oklahoma City Oklahoma
United States 205.438.01008 Boehringer Ingelheim Investigational Site Orlando Florida
United States 205.438.01014 Boehringer Ingelheim Investigational Site Orlando Florida
United States 205.438.01021 Boehringer Ingelheim Investigational Site Orlando Florida
United States 205.438.01011 Boehringer Ingelheim Investigational Site San Diego California
United States 205.438.01006 Boehringer Ingelheim Investigational Site South Bend Indiana
United States 205.438.01003 Boehringer Ingelheim Investigational Site Syracuse New York
United States 205.438.01004 Boehringer Ingelheim Investigational Site Tuscon Arizona

Sponsors (1)
Lead Sponsor Collaborator
Boehringer Ingelheim

Countries where clinical trial is conducted

United States,  Australia,  Austria,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Hungary,  Ireland,  Israel,  Italy,  Poland,  Portugal,  Russian Federation,  Slovakia,  South Africa,  Spain,  Switzerland,  United Kingdom, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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). 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. No
Primary 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. Baseline and 12 weeks No
Secondary 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). 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. No
Secondary 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. Baseline and 12 weeks No
Secondary 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. Baseline and 12 weeks No
Secondary 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. 12 weeks No
Secondary 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. Baseline and 12 weeks No
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