Randomised, double-blind study to demonstrate therapeutic equivalence of formoterol fumarate 12µg capsules delivered by Cyclohaler with Foradil in mild to moderate reversible obstructive airways disease.

Phase 1

• Conditions: mild to moderate reversible obstructive airways disease

• Registration Number: EUCTR2005-002538-37-GB
• Lead Sponsor: Pharmachemie B.V.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-07-07
• Last Update Posted: 25 November 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 30

Inclusion Criteria

1.Clinical diagnosis of mild to moderate reversible obstructive airways disease, with exclusion of other significant pulmonary diseases
2. No significant cardiac, other pulmonary, gastrointestinal, hepatic, renal, haematological, uncontrolled diabetes mellitus, neurological and psychiatric disease as determined by medical history, physical examination, biochemical and haematological investigation.
3.Male or female subjects between the ages of 18-65 years inclusive.
4.Baseline FEV1 greater than or equal to 40% of predicted value, based on ECCS standards using the ethnic corrections where appropriate after withholding short-acting beta-2 agonists for 6 hours and long-acting beta-2 agonists for 24 hours
5.Reversibility of FEV1 to 400µg salbutamol by inhalation of at least 15% and 200 mL
6.Subjects on either no inhaled steroids or on a stable dose of inhaled steroids (stable for a minimum of 6 weeks prior to study entry).
7.Female subjects of child bearing potential must test negative on standard serum pregnancy test and must be willing to practice abstinence or appropriate double barrier contraceptive methods for the duration of the study
8.Smoking history of less than 20 pack years; subjects must not have smoked for one month prior to entry onto the study.
9.Written informed consent and willingness to comply with protocol procedures, including being willing and able to omit any current inhaled steroid treatment for the morning of dosing days.
10.Refrain from strenuous exercise 8 hours before and during each 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.History or present evidence of disease, which in the opinion of the Investigator, may affect the subject’s participation in the study or outcome measures.
2.Known pregnancy or lactation.
3.Known hypersensitivity to salbutamol, formoterol or lactose.
4.Involvement in another clinical study with a new chemical entity within the previous four weeks prior to screening.
5.Acute lower respiratory infection within four weeks prior to screening.
6.Inability to stop any of the prohibited medication, including oral steroids, and subjects on long-acting bronchodilators who are unable to use alternate treatment.
7.Subject on unstable dose of inhaled steroids (not on a stable dose for six weeks prior to entry into the study).
8.Known history of substance/alcohol abuse.
9.Positive test for hepatitis B or hepatitis C.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Primary end point(s): Time weighted change in FEV1 (area under the curve divided by time) to 12 hours post dose;Main Objective: To demonstrate therapeutic equivalence of formoterol fumarate 12 mcg capsules delivered by Cyclohaler with Foradil (with placebo control);Secondary Objective: To demonstrate safety of delivering formoterol fumarate 12 mcg capsules delivered by Cyclohaler