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

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”

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.

Intervention(s) in this Clinical Trial

• Drug: fluticasone/ salmeterol
  • 2 puffs twice a day for 2 weeks
• Drug: fluticasone
  • 2 puffs twice a day for 2 weeks

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1: fluticasone/salmeterol
  • 2 puffs twice a day for 2 weeks
• Active Comparator: 2: fluticasone
  • 2 puffs twice a day for 2 weeks

Primary Measures

• methacholine challenge
  • Time Frame: before and after a 2 week treatment period
    Safety Issue?: No

Secondary Measures

• spirometry
  • Time Frame: before and after a 2 week treatment period
    Safety Issue?: No
• Bmax and Emax
  • Time Frame: before and after a 2 week treatment period
    Safety Issue?: No
• impulse oscillometry
  • Time Frame: before and after a 2 week treatment period
    Safety Issue?: No
• mannitol challenge
  • Time Frame: before and after a 2 week treatment period
    Safety Issue?: No
• serum ECP
  • Time Frame: before and after a 2 week treatment period
    Safety Issue?: No
• overnight urinary cortisol creatnine clearance
  • Time Frame: before and after a 2 week treatment period
    Safety Issue?: Yes

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.

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 65 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: University of Dundee Other

Overall Clinical Trial Officials and Contacts

Karine L Clearie, MBBS, MRCP Principal Investigator Asthma and Allergy Research Group  

Overall Contact: karine L Clearie, MBBS, MRCP 01382 496440 k.clearie@dundee.ac.uk

Information obtained from ClinicalTrials.gov on February 08, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00830505

Study ID Number: CLE001

ClinicalTrials.gov Identifier: NCT00830505

Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency