Fluticasone/Salmeterol (FP/SM) Versus Double the Dose Fluticasone (FP) in Patients With Mild to Moderate Asthma

Condition(s) targeted: Asthma

Intervention: fluticasone/ salmeterol (Drug); fluticasone (Drug)

Phase: Phase 4

Status: Not yet recruiting

Sponsored by: University of Dundee

Official(s) and/or principal investigator(s):
Karine L Clearie, MBBS, MRCP, Principal Investigator, Affiliation: Asthma and Allergy Research Group
Brian J Lipworth, MBchB, Study Director, Affiliation: Asthma and Allergy Research Group

Overall contact:
karine L Clearie, MBBS, MRCP, Phone: 01382 496440, Ext: 36440, Email: k.clearie@dundee.ac.uk

The purpose of this study is to compare the effects of Fluticasone/ salmeterol combination and double the dose of fluticasone on airway hyper-responsiveness to methacholine.

Official title: A Randomized, Double-Blind, Cross-Over Study to Demonstrate Superiority of Fluticasone/Salmeterol Over Double the Dose of Fluticasone on Methacholine Hyper-Reactivity in Patients With Persistent, Mild to Moderate Asthma

Study design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study

Primary outcome: methacholine challenge

Secondary outcome:

spirometry

Bmax and Emax

impulse oscillometry

mannitol challenge

serum ECP

overnight urinary cortisol creatnine clearance

Minimum age: 18 Years. Maximum age: 65 Years. Gender(s): Both.

Criteria:

Inclusion Criteria:

1. Written informed consent given by patient.

2. Male or female patients between 18 and 65 years of age inclusive.

3. Persistent stable asthmatics (FEV1 > 60%)

4. On ≤ 1000 µg FP or equivalent or if on combination therapy up to 500 µg of FP or equivalent (e. g. FP/SM 125 2-puffs BD or BUD/FM 200/6 2-puffs BD)

5. Patients suffering from stable, persistent, mild to moderate asthma as defined by GINA Guidelines and for whom FEV1 > 60 %

6. In the opinion of the investigator, able and willing to comply with the requirements of the protocol.

Exclusion Criteria:

1. Severe asthmatics as defined by an FEV1 < 60% or PEF variability >30% or with continual daytime or nocturnal symptoms.

2. Known or suspected hypersensitivity to FP or any other constituents of the Test or Reference pMDI

3. Any clinically significant medical condition or abnormality, which, in the opinion of the investigator, might compromise the safety of the patient or which might interfere with the study (such as unstable angina, acute myocardial infarction in the preceding 3 months, recent TIA / CVA).

4. Females who are pregnant, lactating or planning to become pregnant.

5. Approximately half of the subjects will be smokers and half currently non-smokers (or who have ceased smoking at least 1 year previously).

6. Clinically significant laboratory values, as judged by the investigator.

7. Receipt of an investigational drug within 30 days or 5 half-lives, whichever is longer, prior to the screening visit.

8. Patients who are scheduled to receive any other investigational drug during the course of the study.

9. Concomitant use of medicines (prescribed, over the counter or herbal) that may interfere with the trial.

10. Exacerbations of asthma requiring oral steroids, hospitalisation or change in asthma therapy in the previous three months.

11. Respiratory tract infection in the previous 2 months.

12. Patients with significant concomitant respiratory disease such as COPD, CF, ABPA, active pulmonary TB or bronchiectesis.

karine L Clearie, MBBS, MRCP, Phone: 01382 496440, Ext: 36440, Email: k.clearie@dundee.ac.uk

Asthma and Allergy Research Group, Dundee, Angus DD1 9SY, United Kingdom

Starting date: February 2009
Ending date: December 2009
Last updated: January 27, 2009