A RANDOMISED, OPEN TWO WAY CROSS-OVER STUDY TO ASSESS THE BRONCHODILATING PROPERTIES OF A NEW SALBUTAMOL-HFA 134a FORMULATION GIVEN AS CUMULATIVE DOSES AND A REFERENCE SALBUTAMOL-HFA 134a FORMULATION IN ADULT ASTHMATIC PATIENTS

• Conditions: Documented asthma for at least 6 months before screeningSubjects with a FEV1 of between 50-85% of the predicted normal value for age, height and gender after withholding short acting Beta2-agonists for at least 6 hours and long-acting Beta2-agonists for at least 24 hours.

• Registration Number: EUCTR2005-000276-40-HU
• Lead Sponsor: GENERICS [UK] Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2005-02-11
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

At study entry:
1.Male and female asthmatic patients, aged 18 - 45 years inclusive.
2. Documented asthma for at least 6 months before screening.
3.Subjects with a FEV1 between 50% and 85% of the predicted normal value for age, height and gender.
4.Subjects who demonstrate a reversibility of > 12% in FEV1 10 minutes after a dose of 200?g salbutamol from a standard salbutamol pMDI, after withholding short acting ?2-agonists for at least 6 hours and long acting ?2-agonists for at least 24 hours.
5.Subjects who are able to handle a pMDI correctly without the aid of air chambers.
6.Subjects who are willing to give written informed consent to participate in the study.

On study days:
1.A pre-dose baseline FEV1 within 10% of the value obtained at the Screening Visit.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Patients currently receiving oral corticosteroid therapy or who have received oral corticosteroid therapy in the 3 months preceding the screening.
2.Patients currently receiving therapy for an upper respiratory tract infection or who have received such a therapy in the month prior to the start of the study.
3.Patients who have been hospitalised or received emergency treatment for an exacerbation of asthma in the 3 months prior to the start of the study.
4.Patients with a known or suspected hypersensitivity to salbutamol or it’s excipients.
5.Patients who have experienced bronchospasms following the administration of HFA 134a containing products.
6.Patients who are unable to perform lung function tests.
7.Patients with any of the following concurrent conditions:
•Uncontrolled diabetes mellitus
•Evidence of current neoplastic disease other than basal cell carcinoma
•Evidence of tuberculosis
•Evidence of significant cardiovascular disease
•Respiratory disorders other than asthma or rhinitis
•Significant hepatic or renal insufficiency.
•Evidence or history of alcohol or drug abuse.
•Evidence or history of low potassium levels.
8.Patients currently receiving other investigational medication or who have received investigational medication in the 3 months prior to the screening of the study.
9.Employees of Merck Generics [UK] Ltd. or the CRO responsible for the execution of the study.
10.Women who are pregnant, lactating or likely to become pregnant during the course of the study. Women of child bearing potential will be eligible to enter the study if using adequate contraception (i.e. contraceptive pill or barrier methods).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the clinical comparability of salbutamol-HFA 134a and Ventolin Evohaler® in a cumulative dose design;Secondary Objective: To evaluate the safety and tolerability of salbutamol-HFA 134a;Primary end point(s): Since this is a cross-over trial no endpoint period is defined. <br>The baseline periods for assessment of the change in FEV1 is defined as the values obtained before T=0.00 hr at Visit 1 and Visit 2