Asthma MedDRA version: 9.1 Level: LLT Classification code 10003553 Term: Asthma
Conditions
Interventions
Product Name: PF-610,355
Product Code: PF-610,355
Pharmaceutical Form: Inhalation powder
CAS Number: 862541-45-5
Current Sponsor code: P
Sponsors
Pfizer Ltd. Ramsgate Road, Sandwich, Kent, UK
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female subjects aged 18 to 65 years inclusive. Females may be of either child-bearing or non-child bearing potential. 2. All females of childbearing potential may be included provided they are not pregnant (negative urinary pregnancy test) or nursing, and are practicing acceptable contraception methods. 3. Subjects with a physician documented history or diagnosis of persistent asthma (according to Global Initiative in Asthma, GINA, 2006) definition of asthma, for at least 6 months prior to Screening 1. 4. Subjects who have been maintained on a stable dose of ICS over the previous month prior to Screening 1. 5. Screening FEV1 measure of >60% of predicted value for age, height and sex (using Community for Coal and Steel (ECCS) standards), following withdrawal of long-acting beta-agonist for a minimum of 72 hours and short-acting beta-agonist for a minimum of 8 hours. Measurement and reproducibility should conform to current ATS guidelines. 6. Subjects must demonstrate =15% improvement in FEV1 (and = 200mL increase) within 15-45 minutes following 200 microgram salbutamol administered from a metered-dose inhaler (MDI) using a spacer. 7. Subjects with stable disease for at least the previous 3 months (i.e. no exacerbations requiring treatment with oral corticosteroids and no asthma-related hospital admissions). Subjects should have had no more than 1 exacerbation in the previous year prior to Screening 1. 8. Subjects with rescue medication use not exceeding 5 occasions per week over the 3 weeks prior to Screening 1. 9. Subjects who do not use short-acting bronchodilators at rest. 10. Body mass index (BMI) of approximately 18 to 33kg/m2 and a body weight of >50kg (110lbs). On a case-by-case basis (after discussion with the Pfizer Clinician), subjects with a BMI 33kg/m2 may be allowed in the study provided that BMI is proportionate to physical build, weight is stable and the subject is not morbidly obese, anorexic, bulimic or cachectic. 11. Subjects must be able to use the inhalation devices. 12. Subjects must be able to give informed written consent prior to entering the study. 13. Subjects must be willing and able to comply with scheduled visits and all study related procedures 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
Exclusion criteria: 1. History or evidence, based on complete medical history, full physical examination, 12-lead ECG, or clinical laboratory test results, of any significant concomitant clinical disease (excluding asthma) including haematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic, or allergic disease that may adversely affect the safety of the subject or the interpretation of the results of the study. Inclusion of subjects with significant disease (other than asthma) will need to be reviewed on an individual basis with the Pfizer Clinician. 2. Subjects with seasonal or perennial allergy may be included provided they are either asymptomatic or are willing to be maintained throughout the study using a regular dose of intranasal corticosteroids and/or intranasal anti-histamines only and the allergy is known not to cause a worsening of asthma symptoms. 3. Stable, well-controlled conditions such as controlled hypertension [but excluding those on beta-blockers and calcium channel blockers (Class I and II)], thyroid disease, well-controlled Type 1 and Type 2 diabetes, hypercholesterolaemia and gastroesophageal reflux are acceptable provided the symptoms and medication would not be predicted to compromise safety or interfere with the tests and interpretation of the study. 4. Subjects currently maintained on antimuscarinic agents, leukotriene receptor antagonists, theophylline, oral corticosteroids, Xolair, nedocromil or cromolyn are excluded. Subjects who have withdrawn from treatment with antimuscarinic agents, leukotriene receptor antagonists or theophylline, for greater than 2 weeks prior to Screening 1 are allowed. 5. Subjects requiring rescue medication on greater than 2 occasions in the 72 hours prior to Screening 2 (Visit 2) or any use of rescue medication at rest in the 72 hours prior to Screening 2. 6. Subjects who have evidence of drug or alcohol abuse. 7. Subjects who are current smokers. Ex smokers who have given up smoking for 160mmHg or DBP >100mmHg, resting hypotension (SBP100bpm, QRS duration >120msec, QTcB >450msec, PR interval >220msec, any clinically significant rhythm abnormality or evidence of myocardial injury or ischemia. The assessment of QTc should be made by Principal Investigator. 11. Subjects with seasonally unstable asthma where the season will coincide with the subject’s participation in the study. 12. Subjects with a history of pulmonary disease other than asthma. 13. Respiratory tract infection in the 4 weeks prior to
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To test all doses of PF-610,355 for superiority of trough (24 hour post-dose) FEV1 versus placebo. To characterize the relationship of PF-610,355 dose to peak and trough FEV1 ; Secondary Objective: • To characterize the relationship of PF-610,355 dose to peak and trough peak expiratory flow rate (PEFR). • To test all doses of PF-610,355 for superiority of trough (24 hour post-dose) PEFR versus placebo. • To ‘bench-mark’ the efficacy (FEV1 peak effect) of PF-610,355 against salmeterol 50 microgram. • To investigate the pharmacokinetics of PF-610,355 delivered via CRC749 in asthmatic subjects. • To investigate the safety and toleration of PF-610,355 delivered via CRC749 in asthmatic subjects. ;Primary end point(s): Peak and trough (24 hour post-dose) FEV1. | — |
Countries
Germany, Sweden, United Kingdom
Outcome results
None listed