A Phase II randomised, double-blind, placebo controlled, cross-over efficacy and safety comparison of three doses of tiotropium inhalation solution delivered via Respimat® inhaler (1.25, 2.5 and 5.0 µg once daily) versus placebo in patients with moderate persistent asthma. - TinA dose confirmation in GINA 3/4

Boehringer Ingelheim RCV GmbH & Co KG0 sites120 target enrollmentOctober 5, 2010

Conditionsmoderate persistent asthma MedDRA version: 13.1Level: LLTClassification code 10003555Term: Asthma bronchialSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders

DrugsSpiriva Respimat 2.5 microgram, solution for inhalation

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: moderate persistent asthma
Sponsor: Boehringer Ingelheim RCV GmbH & Co KG
Enrollment: 120
Status: Active, not recruiting
Last Updated: 13 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

October 5, 2010

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Investigators

Sponsor

Boehringer Ingelheim RCV GmbH & Co KG

Eligibility Criteria

Inclusion Criteria

•1\. All patients must sign and date an Informed Consent Form consistent with ICH\-GCP guidelines and local legislation prior to participation in the trial (i.e. prior to any trial procedures, including any pre\-trial washout of medications and medication restrictions for pulmonary function test at Visit 1\).
•2\. Male or female patients aged between 18 and 75 years (at date of informed consent).
•3\. All patients must have at least a 3 month history of asthma at the time of enrolment into the trial. The diagnosis should be confirmed at Visit 1 by fulfilling inclusion criterion no. 5\.
•4\. The initial diagnosis of asthma must have been made before the patient's age of 40\.
•5\. The diagnosis of asthma has to be confirmed at Visit 1 with a bronchodilator reversibility (15 to 30 minutes after 4 puffs of 100 µg salbutamol) resulting in a FEV1 increase of \= 12% and \= 200mL (see Appendix 10\.3\).
•6\. All patients must have been on maintenance treatment with a medium, stable dose of inhaled corticosteroids (as detailed in Appendix 10\.3\) (alone or in a fixed combination with a LABA or SABA) for at least 4 weeks prior to Visit 1\.
•7\. All patients must be symptomatic at Visit 1 (screening) and prior to randomisation at Visit 2 as defined by an ACQ (see Appendix 10\.4\) mean score of \= 1\.5\.
•NOTE: If the patient is not eligible due to the predefined score at Visit 1, the patient should not be further evaluated. If the patient is not eligible due to the predefined score at Visit 2, the patient’s Visit 2 can be repeated once for further assessment (see section 6\.1\).
•8\. All patients must have a pre\-bronchodilator FEV1 \= 60% and \= 90% of predicted normal at Visit 1\. Predicted normal values will be calculated according to ECSC \[R94\-1408] (see Appendix 10\.3\).
•9\. Variation of absolute FEV1 values of Visit 1 (pre\-bronchodilator) as compared to Visit 2 (pre\-dose) must be within ± 30% (see Appendix 10\.3 for calculation).

Exclusion Criteria

•1\. Patients with a significant disease other than asthma (which, in the opinion of the investigator, may (i) put the patient at risk because of participation in the trial, or (ii) influence the results of the trial, or (iii) cause concern regarding the patient's ability to participate in the trial.)
•2\. Patients with a clinically relevant abnormal screening (Visit 1\) haematology or blood chemistry if the abnormality defines a significant disease as defined in exclusion criterion 1\.
•3\. Patients with a recent history (i.e. six months or less) of myocardial infarction.
•4\. Patients who have been hospitalised for cardiac failure during the past year.
•5\. Patients with any unstable or life\-threatening cardiac arrhythmia or cardiac arrhythmia requiring intervention or a change in drug therapy within the past year.
•6\. Patients with lung diseases other than asthma (e.g. COPD).
•7\. Patients with known active tuberculosis.
•8\. Patients with malignancy for which the patient has undergone resection, radiation therapy or chemotherapy within the last five years. Patients with treated basal cell carcinoma are allowed.
•9\. Patients who have undergone thoracotomy with pulmonary resection. Patients with a history of thoracotomy for other reasons should be evaluated as per exclusion criterion no. 1\.
•10\. Patients with known moderate to severe renal impairment (as judged by the investigator).