Safety Study Using GSK573719 And Tiotropium In Patients With Chronic Obstructive Pulmonary Disease

NCT00515502 | Completed Phase 2 Results

• 1 other identifier: AC4108123
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 3

Brief Summary

GSK573719 is a high-affinity specific muscarinic receptor (mAChR) antagonist which is being developed for once daily treatment of chronic obstructive pulmonary disease (COPD). The long duration of action of GSK573719 when administered via inhalation in animal models supports the potential for use as a once-daily bronchodilator for COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Keywords

chronic obstructive pulmonary disease,; GSK573719,; muscarinic receptor antagonist

Outcome Measures

Primary Outcomes (24)

• Number of Participants With Any Adverse Event (AE) or Any Serious Adverse Event (SAE)

  An AE is defined as any untoward medical occurrence in a clinical investigation participant, temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product. An AE can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of a medicinal product. An SAE is defined as any untoward medical occurrence that, at any dose, results in death, is life threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect, may jeopardize the participant or may require medical or surgical intervention to prevent one of the other outcomes listed in this definition, or is an event of possible drug-induced liver injury. Refer to the general AE/SAE module for a list of AEs and SAEs.

  From Day 1 of Treatment Period 1until Follow-up (up to 10 weeks)

• Maximum (0-4 Hours) Heart Rate on Day 1 of Each Treatment Period

  Resting heart rate was measured at pre-dose and 15 minutes (min), 45min, 1.5 hour (h) 4 h, 8 h, and 24 h post-dose of each treatment period and the maximum value for heart rate (0-4hours) was derived at rest. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Weighted Mean (0-4 Hours) Heart Rate at Day 1 of Each Treatment Period

  Resting heart rate was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for heart rate (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Maximum (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period

  Resting systolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for systolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Weighted Mean (0-4 Hours) Systolic Blood Pressure at Day 1 of Each Treatment Period

  Resting systolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for systolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Maximum (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period

  Resting diastolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for diastolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Weighted Mean (0-4 Hours) Diastolic Blood Pressure at Day 1 of Each Treatment Period

  Resting diastolic blood pressure was measured at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for diastolic blood pressure (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Maximum (0-4 Hours) QTcB at Day 1 of Each Treatment Period

  Twelve-lead ECGs (electrocardiograms) were performed to measure QT interval corrected according to Bazzet's formula (QTcB) at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for QTcB (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Weighted Mean (0-4 Hours) QTcB at Day 1 of Each Treatment Period

  Twelve-lead ECGs were performed to measure QTcB at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for QTcB (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Maximum (0-4 Hours) QTcF at Day 1 of Each Treatment Period

  Twelve-lead ECGs were performed to measure QT interval corrected according to Fredericia's formula (QTcF) at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the maximum value for QTcF (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Weighted Mean (0-4 Hours) QTcF at Day 1 of Each Treatment Period

  Twelve-lead ECGs were performed to measure QTcF at pre-dose and 15 minutes (min), 45 min, 1.5 hours (h), 4 h, 8 h and 24 h post-dose of each treatment period and the weighted mean value for QTcF (0-4 hours) was derived. Baseline is the mean of the 3 pre-dose measurements for each period. Participant level Baseline is the mean of the Baselines for each participant and period level Baseline is the difference between the Baseline and the participant level Baseline in each treatment period for each participant. Analysis was performed using a mixed model with participant level Baseline, period level Baseline, period and treatment group were fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Maximum (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period

  Twenty-four hour Holter monitoring was conducted to measure heart rate for the 24-hour period following dosing at each treatment period and the maximum value for heart rate (0-24 hours) was derived. Analysis was performed using a mixed model of period and treatment group fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Mean (0-24 Hours) Heart Rate as Measured From Holter Monitoring at Day 1 of Each Treatment Period

  Twenty-four-hour Holter monitoring was conducted to measure heart rate for the 24-h period following dosing of each treatment period and the mean value for heart rate (0-24 hours) was derived. Analysis was performed using a mixed model of period and treatment group fitted as fixed effects and participant as a random effect.

  Day 1 of each treatment period (up to Study Day 46)

• Basophils, Eosinophils, Lymphocytes, Monocytes, and Total Neutrophils Values at the Indicated Time Points on Day 1 of Each Treatment Period

  Blood samples were collected for the measurement of basophils, eosinophils, lymphocytes, monocytes, and total neutrophils at pre-dose and 24 hour (h) post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

• Hemoglobin, Mean Corpuscle Hemoglobin Concentration (MCHC), Albumin and Total Protein Values at the Indicated Time Points on Day 1 of Each Treatment Period

  Blood samples were collected for the measurement of hemoglobin, MCHC, albumin and total protein at pre-dose and 24 hour (h) post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

• Hematocrit Values at the Indicated Time Points on Day 1 of Each Treatment Period

  Blood samples were collected for the measurement of hematocrit at pre-dose and 24 hour (h) post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

• Mean Corpuscle Hemoglobin Values at the Indicated Time Points on Day 1 of Each Treatment Period

  Blood samples were collected for the measurement of the mean corpuscle hemoglobin at pre-dose and 24 hour (h) post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

• Mean Corpuscle Volume Values at the Indicated Time Points on Day 1 of Each Treatment Period

  Blood samples were collected for the measurement of the mean corpuscle volume at pre-dose and 24 hour (h) post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

• Red Blood Cells Count Values at the Indicated Time Points on Day 1 of Each Treatment Period

  Blood samples were collected for the measurement of the red blood cells count at pre-dose and 24 hour (h) post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

• Platelets Count and White Blood Cells (WBC) Count Values at the Indicated Time Points on Day 1 of Each Treatment Period

  Blood samples were collected for the measurement of platelets count and WBC count at pre-dose and 24 hour (h) post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

• Alkaline Phosphatase (ALP), Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Creatine Phosphokinase (CPK), and Gamma Glutamyl Transferase (GGT) Values at the Indicated Time Points on Day 1 of Each Treatment Period

  Blood samples were collected for the measurement of ALP, ALT, AST, CPK, and GGT at pre-dose and 24 hour (h) post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

• Total Bilirubin, Creatinine and Uric Acid Values at the Indicated Time Points on Day 1 of Each Treatment Period

  Blood samples were collected for the measurement of total bilirubin, creatinine, and uric acid at pre-dose and 24 hour (h) post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

• Calcium, Bicarbonate, Chloride, Glucose, Inorganic Phosphorus (IP), Potassium, Sodium, and Urea Values at the Indicated Time Points on Day 1 of Each Treatment Period

  Blood samples were collected for the measurement of the calcium, bicarbonate, chloride, glucose, IP, potassium, sodium, and urea at pre-dose and 24 hour (h) post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

• Forced Expiratory Volume in 1 Second (FEV1) and Forced Vital Capacity (FVC) at the Indicated Time Points on Day 1 of Each Treatment Period

  FEV1 and FVC are measures of lung function. FEV1 is defined as the maximal amount of air that can be forcefully exhaled in one second. FVC is defined as the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. FEV1 and FVC measurements were taken at pre-dose and 1 hour (h), 2 h, 6 h, 9 h, 12 h and 24 h post-dose of each treatment period.

  Day 1 of each treatment period (up to Study Day 46)

Secondary Outcomes (9)

• Area Under Concentration-time Curve From Time 0 to 2 Hours [AUC(0-2)] and Area Under Concentration-time Curve From Time 0 to Time of Last Quantifiable Concentration [AUC(0-t)] of UMEC

  Day 1 of each treatment period (up to Study Day 46)

• Maximum Observed Plasma Concentration (Cmax) of UMEC

  Day 1 of each treatment period (up to Study Day 46)

• Time of Maximum Observed Plasma Concentration (Tmax), Last Time Point Where the Concentration is Above the Limit of Quantification (Tlast), and Plasma Half-life (t1/2) of UMEC

  Day 1 of each treatment period (up to Study Day 46)

• Amount of Drug Excreted Unchanged in Urine From Time Zero to: 2h [Ae(0-2)] , 8h [Ae(0-8)], 12h [Ae(0-12)], 24h [Ae(0-24)], and 48h [Ae(0-48)]; and Area Under the Excretion Rate Curve From Time Zero to: 18h [AUER(0-18)] and 36h [AUER(0-36)] for UMEC

  Day 1 of each treatment period (up to Study Day 46)

• Renal Clearance (CLr) of UMEC Following Dose Administration on Day 1

  Day 1 of each treatment period (up to Study Day 46)

Study Arms (12)

Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, placebo

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: umeclidinium bromide (UMEC) 250 micrograms (µg), UMEC 500 µg, Tiotropium 18 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719; Drug: Tiotropium

Seq 2: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg, placebo

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719

Seq 3: UMEC 250 µg, placebo, UMEC 500 µg, UMEC 1000 µg

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719

Seq 4: UMEC 250 µg, UMEC 500 µg, placebo, UMEC 1000 µg

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, UMEC 500 µg, placebo and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719

Seq 5: Placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, UMEC 500 µg and UMEC 1000 µg. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719

Seq 6: UMEC 250 µg, placebo, Tiotropium 18 µg, UMEC 500 µg

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719; Drug: Tiotropium

Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, Tiotropium 18 µg, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719; Drug: Tiotropium

Seq 8: Tiotropium 18 µg, placebo, UMEC 250 µg, UMEC 500 µg

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, placebo, UMEC 250 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719; Drug: Tiotropium

Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, placebo

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg and placebo. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719; Drug: Tiotropium

Seq 10: Tiotropium 18 µg, UMEC 250 µg, placebo, UMEC 500 µg

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Tiotropium 18 µg, UMEC 250 µg, placebo and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719; Drug: Tiotropium

Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: Placebo, UMEC 250 µg, Tiotropium 18 µg and UMEC 500 µg. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719; Drug: Tiotropium

Seq 12: UMEC 250 µg, placebo, UMEC 500 µg, Tiotropium 18 µg

ACTIVE COMPARATOR

Participants received single doses of 4 treatments, over 4 treatment periods, in the following sequence: UMEC 250 µg, placebo, UMEC 500 µg and Tiotropium 18 µg. Treatment periods were seperated by a washout period of at least 14 days.

Drug: GSK573719; Drug: Tiotropium

Interventions

GSK573719 DRUG

250 micrograms (μg) per blister, administered via dry powder inhaler, dose-ascending study doses began at 250 ug, then 500 ug, and 1000 μg

Seq 10: Tiotropium 18 µg, UMEC 250 µg, placebo, UMEC 500 µg; Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg; Seq 12: UMEC 250 µg, placebo, UMEC 500 µg, Tiotropium 18 µg; Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, placebo; Seq 2: UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg, placebo; Seq 3: UMEC 250 µg, placebo, UMEC 500 µg, UMEC 1000 µg; Seq 4: UMEC 250 µg, UMEC 500 µg, placebo, UMEC 1000 µg; Seq 5: Placebo, UMEC 250 µg, UMEC 500 µg, UMEC 1000 µg; Seq 6: UMEC 250 µg, placebo, Tiotropium 18 µg, UMEC 500 µg; Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg; Seq 8: Tiotropium 18 µg, placebo, UMEC 250 µg, UMEC 500 µg; Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, placebo

Tiotropium DRUG

strips of five capsules, each containing 18 μg administered via dry powder inhaler

Seq 10: Tiotropium 18 µg, UMEC 250 µg, placebo, UMEC 500 µg; Seq 11: Placebo, UMEC 250 µg, Tiotropium 18 µg, UMEC 500 µg; Seq 12: UMEC 250 µg, placebo, UMEC 500 µg, Tiotropium 18 µg; Seq 1: UMEC 250 µg, UMEC 500 µg, Tiotropium 18 µg, placebo; Seq 6: UMEC 250 µg, placebo, Tiotropium 18 µg, UMEC 500 µg; Seq 7: Placebo, Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg; Seq 8: Tiotropium 18 µg, placebo, UMEC 250 µg, UMEC 500 µg; Seq 9: Tiotropium 18 µg, UMEC 250 µg, UMEC 500 µg, placebo

Eligibility Criteria

• Age: 40 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Caucasian male or female subjects aged 40-75 years inclusive. The need to recruit only Caucasian subjects is related to the need to rigorously exclude 2D6 poor metabolisers based on genotype.
• Female subjects must be of non-childbearing potential.
• An established clinical history of COPD (ATS/ERS definition).
• 'Chronic obstructive pulmonary disease (COPD) is a preventable and treatable disease characterised by airflow limitation that is not fully reversible. The airflow limitation is usually progressive and is associated with an abnormal inflammatory response of the lungs to noxious particles or gases, primarily caused by cigarette smoking. Although COPD affects the lungs, it also produces significant systemic consequences.'
• Subject is a smoker or an ex-smoker with a smoking history of at least 10 pack years (1 pack year = 20 cigarettes smoked per day for 1 year or equivalent).
• Subject has FEV1/FVC \< 0.7 post-bronchodilator (salbutamol) dose.
• Subject has 40 ≥ FEV1 ≤ 80% of predicted normal for height, age and gender after inhalation of salbutamol dose.
• Response to ipratropium bromide.
• Subject is able and has given written informed consent to take part in the study.
• Subject is available to complete all study measurements and procedures.
• Subject's BMI is 18.0 - 32.0 kg/m2.
• Subjects have a 24hr Holter recording that is within normal limits and does not demonstrate any clinically important abnormality that, in the opinion of the investigator, would make the subject unsuitable for participation in the study

You may not qualify if:

• Subjects who have a past or present disease of any organ system, which as judged by the Investigator, may affect the outcome of this study.
• A suspected history of alcohol abuse within the six months previous to the screening visit.
• The subject has tested positive for hepatitis C antibody, hepatitis B surface antigen or HIV (if determined by local SOP's).
• Subject has received an investigational drug within 30 days of screening.
• The subject is currently taking medication which is known to be a CYP 2D6 inhibitor/substrate.
• The subject has donated a unit (400ml) of blood within 60 days of screening, or, intends to donate during the study.
• The subject has a known allergy or hypersensitivity to ipratropium bromide, tiotropium bromide, atropine and any of its derivatives or lactose/milk protein.
• Subject is unable to use the DISKUS™/HandiHaler devices correctly.
• Subject has prostatic hypertrophy, bladder outlet obstruction, or narrow angle glaucoma.
• Subjects with a 2D6 poor metaboliser genotype (Caucasian).
• The subject has claustrophobia that may be aggravated by entering the plethysmography cabinet (American Association of Respiratory Care 2001 guidelines for body plethysmography)
• Received antibiotic therapy for either a lower respiratory tract infection or for COPD exacerbation within the 4 weeks prior to Screening.
• Respiratory criteria
• Subject has a diagnosis of active tuberculosis, lung cancer, clinically overt bronchiectasis, allergic rhinitis, or asthma.
• Subject has poorly controlled COPD, defined as either: acute worsening of COPD that is managed by the subject at home by treatment with corticosteroids in the 6 weeks prior to screening visit Or more than two exacerbations in the previous 6 months prior to screening that required a course of oral corticosteroids or antibiotics, or, for which the subject was hospitalised.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (3)

GSK Investigational Site

Hanover, Lower Saxony, 30625, Germany

Location

GSK Investigational Site

Berlin, 14050, Germany

Location

GSK Investigational Site

Hamburg, 22291, Germany

Location

Related Publications (1)

• Tal-Singer R, Cahn A, Mehta R, Preece A, Crater G, Kelleher D, Pouliquen IJ. Initial assessment of single and repeat doses of inhaled umeclidinium in patients with chronic obstructive pulmonary disease: two randomised studies. Eur J Pharmacol. 2013 Feb 15;701(1-3):40-8. doi: 10.1016/j.ejphar.2012.12.019. Epub 2012 Dec 28.

  PMID: 23276660 BACKGROUND

Related Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Interventions

GSK573719; Tiotropium Bromide

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Scopolamine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Organic Chemicals; Alkaloids; Heterocyclic Compounds; Bridged Bicyclo Compounds, Heterocyclic; Heterocyclic Compounds, Bridged-Ring

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 9, 2007
• First Posted: August 13, 2007
• Study Start: June 21, 2007
• Primary Completion: November 6, 2007
• Study Completion: November 6, 2007
• Last Updated: August 22, 2017
• Results First Posted: April 24, 2014

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will share

Locations

DE (3)