Study to Assess Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adults With Mild to Moderate Asthma

• Register: ClinicalTrials.gov
• Last refreshed on: 17 October 2012
• Main ID: NCT00995800
• Date of registration: 14/10/2009
• Primary sponsor: Mundipharma Research Limited
• Public title: Study to Assess Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adults With Mild to Moderate Asthma FLT2503
• Scientific title: A Double-blind, Randomised, Incomplete Block, Crossover, Placebo-controlled, Dose-response Study to Assess Bronchial Hyperresponsiveness and Airway Inflammation Effects of FlutiForm® pMDI Low and High Dose in Adult Subjects With Mild to Moderate Asthma
• Date of first enrolment: October 2009
• Target sample size: 46
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT00995800
• Study type: Interventional
• Study design: Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Countries of recruitment

Germany

Key inclusion & exclusion criteria

Inclusion Criteria:

1. Male or female subjects aged between 18 and 55 years inclusive.

2. Females less than one year post-menopausal must have a negative serum or urine
pregnancy test recorded at the screening visit prior to the first dose of study
medication in each treatment period, be non-lactating, and be willing to use adequate
and highly effective methods of contraception throughout the study. A highly
effective method of birth control is defined as those which result in a low failure
rate (i.e., less than 1% per year) when used consistently and correctly such as
sterilisation, implants, injectables, combined oral contraceptives, some IUDs
(Intrauterine Device, hormonal), sexual abstinence or vasectomised partner.

3. Known history of mild to moderate asthma for = 6 months prior to the screening visit.

4. Subject has not received systemic (injectable or oral) corticosteroid medication in
the 12 weeks prior to the study screening visit.

5. Demonstrate a FEV1 of = 60% predicted FEV1 (Quanjer et al, 1993) at the screening
visit, following appropriate withholding of asthma medications (no long-acting
ß2-agonist or short-acting ß2-agonist/anticholinergic use 12 hours and 6 hours prior
to screening, respectively).

6. Demonstrate AMP challenge PC20FEV1 < 60 mg/mL, following appropriate withholding of
asthma medication (no short-acting bronchodilator use 6 hours prior to the AMP
challenge test at Visit 2).

7. Non-smoker for at least 12 months prior to study screening. Ex-smokers must have a
smoking history equivalent to less than "10 pack years" (i.e. at least 1 pack of 20
cigarettes per day for 10 years or 10 packs per day for 1 year, etc.).

8. Demonstrate satisfactory technique in the use of the pMDI.

9. Willing and able to enter information in the diary and attend all study visits.

10. Willing and able to substitute study medication for their pre-study prescribed asthma
medication for the duration of the study.

11. Written informed consent obtained.

Exclusion Criteria:

1. Near fatal or life-threatening (including intubation) asthma within the past year.

2. Hospitalisation or an emergency visit for asthma within 4 weeks prior to the
screening visit.

3. History of omalizumab use within the past 6 months.

4. Current evidence or history of any clinically significant disease or abnormality
including uncontrolled coronary artery disease, congestive heart failure, myocardial
infarction, or cardiac dysrhythmia. 'Clinically significant' is defined as any
disease that, in the opinion of the Investigator, would put the subject at risk
through study participation, or which would affect the outcome of the study.

5. In the investigator's opinion a clinically significant upper or lower respiratory
infection within 4 weeks prior to the screening visit.

6. Significant, non-reversible, active pulmonary disease (e.g. chronic obstructive
pulmonary disease (COPD), cystic fibrosis, bronchiectasis, tuberculosis).

7. Known Human Immunodeficiency Virus (HIV)-positive status.

8. Current evidence or history of alcohol and/or substance abuse within 12 months prior
to the screening visit.

9. Subjects who have taken beta-blocking agents, tricyclic antidepressants, monoamine
oxidase inhibitors, astemizole (Hismanal), quinidine type antiarrhythmics, or potent
CYP 3A4 inhibitors such as ketoconazole within one week prior to the screening visit.

10. History of leukotriene receptor antagonist use, e.g. montelukast, within one week
prior to the screening visit.

11. Current use of medications other than those allowed in the protocol that will have an
effect on bronchospasm and/or pulmonary function.

12. Anti-histamines within 2 weeks prior to the screening visit; non-steroidal
anti-inflammatory drugs, oral decongestants, inhaled cromolyn sodium, nedocromil
sodium within one week prior to the screening visit.

13. Current evidence or history of hypersensitivity or idiosyncratic reaction to test
medications, rescue medication, or components.

14. Use of an investigational drug within 30 days prior to the screening visit (12 weeks
if an oral or injectable steroid).

15. Current participation in a clinical study.



Age minimum: 18 Years
Age maximum: 55 Years
Gender: Both

Health Condition(s) or Problem(s) studied

Asthma

Intervention(s)

Drug: Fluticasone propionate / Formoterol fumarate

Primary Outcome(s)

Effects of each dose strength on bronchial hyperresponsiveness to inhaled adenosine 5'-monophosphate (AMP) challenge. [Time Frame: Yes]

Secondary Outcome(s)

eNO, % of eosinophils in induced sputum, comp each dose placebo of bronchial hyperresponsive to AMP challenge. Lung func, rescue med use, asthma symps,& exacerbations sleep disturbance, discon due to lack of efficacy & spontaneously reported AEs. [Time Frame: Yes]

Secondary ID(s)

2009-009873-87

FLT2503

Source(s) of Monetary Support

Please refer to primary and secondary sponsors