Tiotropium Bromide in Cystic Fibrosis

Boehringer Ingelheim

Status and phase: Completed; Phase 3

Conditions: Cystic Fibrosis

Treatments: Drug: tiotropium Respimat® inhaler; Drug: Placebo Respimat® inhaler

Study type: Interventional

Funder types: Industry

Identifiers

NCT01179347

205.438

2010-019802-17 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 464 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

464 participants in 2 patient groups, including a placebo group

tiotropium

Experimental group

Description:

2 inhalations once daily delivered with Respimat® inhaler

Treatment:

Drug: tiotropium Respimat® inhaler

placebo

Placebo Comparator group

Description:

2 inhalations once daily delivered with Respimat® inhaler

Treatment:

Drug: Placebo Respimat® inhaler