Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT00347139
• Date of registration: 29/06/2006
• Prospective Registration: No
• Primary sponsor: GlaxoSmithKline
• Public title: Repeat Doses Of A New Medication (GW642444) In Asthmatic Patients
• Scientific title: Multi-centre, Randomised, Double-blind, Placebo-controlled, Four-way Incomplete Block Crossover Study, to Examine Efficacy, Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Repeat Administration of Three Inhaled Doses (25, 100 and 400 mcg Once Daily) of GW642444
• Date of first enrolment: May 23, 2006
• Target sample size: 55
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00347139
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Triple (Participant, Care Provider, Investigator).
• Phase: Phase 2

Countries of recruitment

Germany, Netherlands, New Zealand, Russian Federation, Sweden, United Kingdom

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion criteria:

- Subjects with a documented history of persistent asthma.

- Current non-smokers.

- Clinically stable persistent asthma FEV1 between 60 and 90% of predicted values.

- Inhaled corticosteroid therapy at a total daily dose between 200-500mcg of fluticasone
or equivalent.

Exclusion criteria:

- Subjects with significant past or present disease which which may affect their safety.

- Upper or lower respiratory tract infection within 4 weeks of screening.

- History of life threatening asthma, or asthma requiring treatment with oral
corticosteroids within 3 months of study.

- Patients taking doses of inhaled corticosteroid >500mcg/day and patients who have
changed therapy within 8 weeks of the study.

- Patients weighing less than 50kg.



Age minimum: 18 Years
Age maximum: 70 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Drug: GW642444 (25, 100 & 400 mcg/day)

Drug: Salmeterol 50mcg

Primary Outcome(s)

Mean change from Baseline (pre-dose on Day 1) in the mean of 23 and 24 hour (h) visit (pre-bronchodilator and pre-dose) trough FEV1 after repeat dosing over 14 days [Time Frame: From Baseline (pre-dose on Day 1) and up to 14 days]

Secondary Outcome(s)

Mean change from Baseline (pre-dose on Day 1) in PM FEV1 from electronic flow meter over 14 days [Time Frame: Baseline (pre-dose on Day 1) and up to Day 14]

Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14 [Time Frame: Day 1, 7, and 14]

Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14 [Time Frame: Day 1, 7, and 14]

Mean change from Baseline (pre-dose on Day 1) in the evening (PM) PEFR from electronic flow meter over Days 1-14 [Time Frame: Baseline (pre-dose on Day 1) and up to 14 days]

Mean change from Baseline (pre-dose on Day 1) in AM FEV1 from electronic flow meter over Days 2-15 [Time Frame: Baseline (pre-dose on Day 1), Day 2, and Day 15]

Mean change from Baseline (pre-dose on Day 1) in morning (AM) Peak expiratory flow rate (PEFR) from electronic flow meter over Days 2-15 [Time Frame: Baseline (pre-dose on Day 1) and up to 15 days]

Mean change from Baseline (pre-dose on Day 1) in weighted mean clinic FEV1 on Day 1 and Day 14 [Time Frame: From Baseline (pre-dose on Day 1) and at 0-2 h, 0-4, and 0-24 h Days 1 and 14]

Secondary ID(s)

B2C106093

Source(s) of Monetary Support

Please refer to primary and secondary sponsors