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Completed

NCT Number: NCT00347139

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

In order to obtain information on a wider range of doses of GW642444 (a possible new medication to treat asthma) than has been previously examined in asthmatic patients, this current study will be conducted at doses of 25 100 and 400 mcg of GW642444 and will be compared with salmeterol (50 mcg twice daily). This study will be conducted in a similar manner to a study that has already been completed (study number B2C101762) which examined repeat doses of 50, 100 and 200 mcg of GW642444. The data obtained will compliment the data from study B2C101762 and will provide confidence (or not) that the desired bronchodilation can be achieved and maintained without undesirable side effects.

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Key information

Conditions

Pulmonary Disease, Chronic Obstructive Chronic Disease Disease Attributes Lung Diseases Lung Diseases, Obstructive Pathologic Processes Pathological Conditions, Signs and Symptoms Respiratory Tract Diseases

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

GSK Investigational Site, Wiesbaden, Hesse, Germany

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GW642444 (25, 100 & 400 mcg/day)

Drug

25, 100 and 400mcg/dose

Salmeterol 50mcg

Drug

Salmeterol 50mcg

Primary outcomes

  1. 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

    The forced expiratory volume in one second (FEV1) is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was defined as the value recorded pre-dose (before dosing) on Day 1. Least square mean change along with standard error has been presented.

Secondary outcomes

  1. 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

    The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. Baseline was the pre-dose value recorded on Day 1. Weighted means have been presented as least square means. Analysis performed using mixed effect ANCOVA with fixed effects covariates of baseline FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient.

  2. 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

    The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. AM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and AM PEFR was calculated in each morning, over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline AM PEFR, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.

  3. 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

    The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. PM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and PM PEFR was calculated in each evening over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline PM PEFR, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.

  4. 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

    The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. AM FEV1 values were measured by electronic flow meter and was measured in the morning over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of baseline AM FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.

  5. 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

    The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change from Baseline is the value at indicated time point minus the Baseline value. PM FEV1 values were measured by electronic flow meter and was measured in the evening over period. Analysis performed using mixed effect ANCOVA with fixed effects covariates of Baseline PM FEV1, center, sex, age, treatment period, treatment and the mean of the participants Baseline values. Participant was fitted as a random coefficient. Least square mean change along with standard error has been presented.

  6. Change in AM PEFR from Pre-AM Dose to Post-AM Dose at Day1, 7, and 14

    Time frame: Day 1, 7, and 14

    The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change in post-AM PEFR is the value at indicated time point minus the pre-AM PEFR value. AM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and AM PEFR was calculated in each morning, over period.

  7. Change in PM PEFR from Pre-PM Dose to Post-PM Dose at Day1, 7, and 14

    Time frame: Day 1, 7, and 14

    The forced expiratory volume in one second is the amount of air exhaled in one second after an forceful inspiration. Change in post-PM PEFR is the value at indicated time point minus the pre-PM PEFR value. PM PEFR values were measured by electronic flow meter. PEFR is maximum speed of expiration of participant as measured by the device and PM PEFR was calculated in each morning, over period.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Jul 4, 2006
Registry last updated
Sep 14, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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