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A Blinded Study To Examine The Ability Of PF-610,355 To Open The Airways In Asthmatic Patients.

A Phase IIA Randomised, Double-blind, Double Dummy, Placebo and Active Controlled 5-Way Cross-over Trial to Examine the Bronchodilator Effects of PF-610,355 and to Test for Superiority Versus Placebo in Reversible Asthmatic Patients

Status
Completed
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00468975
Enrollment
42
Registered
2007-05-03
Start date
2007-05-31
Completion date
Unknown
Last updated
2010-11-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Asthma

Brief summary

A study to determine the ability of different doses of PF-610,355 to open the airways in asthmatic patients by comparison with placebo and a marketed drug that also opens the airways in asthmatic patients.

Interventions

DRUGPF-610,355
DRUGSalmeterol

Sponsors

Pfizer
Lead SponsorINDUSTRY

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
DOUBLE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* Reversible asthmatic patients (\>15% increase in FEV1 following 200ug salbutamol). * FEV1 greater than or equal to 60% predicted * Stable disease for at least the previous 3 months

Exclusion criteria

* Subjects requiring rescue medication on greater than 2 occasions in the 72 hours prior to screening * Subjects with a history of pulmonary disease other than asthma.

Design outcomes

Primary

MeasureTime frame
Peak and Trough (24 hour post dose) FEV1.—

Secondary

MeasureTime frame
FEV1 and PEFR measurements to 32 hours post dose.—
Pharmacokinetics of PF-610,355 and salmeterol—
Peak and trough (24 hour post dose) PEFR—
Safety/Pharmacodynamic end points - pulse rate, blood pressure, QTcF, plasma potassium, blood glucose and AEs.—

Countries

Germany, Sweden, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026