A Single-Centre, Randomised, double-blind, two month Interventional Parallel group Study Assessing the in vivo synergy of salmeterol xinafoate/fluticasone propionate (50/250 µg twice daily) via a single Diskus inhaler (combination) versus salmeterol xinafoate (50 µg twice daily) and fluticasone propionate (250µg twice daily) via separate Diskus inhalers (concurrent treatment) on eosinophilic inflammation in the lungs of adult subjects > 18 years old who have moderate bronchial asthma. - Synergy 2006

Phase 1

• Conditions: Eosinophilic inflammation in the lungs of adult subjects > 18 years old who have moderate bronchial asthma.; MedDRA version: 8.1Level: LLTClassification code 10003555Term: Asthma bronchial

• Registration Number: EUCTR2006-005097-52-IE
• Lead Sponsor: Adelaide & Meath Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-12-05
• Last Update Posted: 3 April 2017

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Gender: Male or Female.
A female is eligible to enter this study if she is of:
- Non-childbearing potential (i.e. physiologically incapable of becoming pregnant, including any female who is post-menopausal), or
- Child-bearing potential, has a negative urinary pregnancy test at screening and agrees to take contraceptive precautions (including abstinence) which are adequate to prevent pregnancy during the study. Acceptable methods of contraception are:
--Male partner who is sterile prior to the female subject’s entry into the study and is the sole sexual partner for that female subject
--Implants of levonorgesterel
--Injectable progestogen
--Oral contraceptive (either combined or progestogen)
--Any intrauterine device (IUD) with a documented failure rate of less than 1% per year.

2. Age: Greater than or equal to 18 years of age.

3. Respiratory Disease Qualification:
Each subject must have been previously diagnosed or treated for bronchial asthma, or have a history and finding suggestive of bronchial asthmas as defined by the GINA guidelines:
Asthma is a chronic inflammatory disorder of the airways in which many cells and cellular elements play a role. The chronic inflammation causes an associated increase in airway hyper responsiveness that leads to recurrent episodes of wheezing, breathlessness, chest tightness, and coughing, particularly at night or in the early morning. These episodes are usually associated with widespread but variable airflow obstruction that is often reversible either spontaneously or with treatment
Percentage of eosinophils in induced sputum =3%.

4. Informed Consent: Subjects are willing to give their written informed consent to participate in the study.

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) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Smoking history: Pack-years > 10 years

2. Known or suspected Chronic Obstructive Pulmonary Disease

3. Other Medication for Asthma: Use of oral, depot or parenteral corticosteroids within 4 weeks of the screening visit or concomitant medication with antileukotriene and/or theophylline drugs

4. Other Diseases/Abnormalities: Historical or current evidence of clinically significant uncontrolled disease likely (in the opinion of the investigator) to interfere with the study. Significant is defined as any disease that, in the opinion of the investigator, would put the safety of the subject at risk through study participation, or would affect the efficacy or safety analysis if the disease/condition exacerbated during the study.

5. Drug Allergy: Any adverse reaction including immediate or delayed hypersensitivity to any beta-agonist, sympathomimetic drug, or any intranasal, inhaled, or systemic corticosteroid therapy.

6. Infections: Upper or lower respiratory tract infections within four weeks immediately preceding Visit 1.

7. Questionable Compliance with Medications or Visits: Any infirmity, disability, or geographic location which would limit compliance for scheduled visits.

8. Inability to read and understand English: Due to the fiscal constraints of an investigator led study, it will be impossible to provide translation services, therefore, subjects will not be eligible if s/he is not able to read and understand English.

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 in vivo synergy of salmeterol xinafoate/fluticasone propionate (50/250 µg twice daily) via a single Diskus inhaler (combination) versus salmeterol xinafoate (50 µg twice daily) and fluticasone propionate (250µg twice daily) via separate Diskus inhalers (concurrent treatment) on eosinophilic inflammation in the lungs of adult subjects > 18 years old who have moderate bronchial asthma.;Secondary Objective: Comparison of percentage differential cell counts in induced sputum and levels of inflammatory mediators in induced sputum.;Primary end point(s): The primary endpoint of the study is to investigate the synergistic effect of salmeterol xinafoate/fluticasone propionate (combination) 50/250 µg twice daily administered in a single inhaler versus fluticasone propionate 250 µg twice daily and salmeterol Xinafoate 50 µg twice daily administered in two separate inhalers on the percentage of eosinophils in induced sputum.