A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)

• Register: ClinicalTrials.gov
• Last refreshed on: 16 December 2017
• Main ID: NCT01372410
• Date of registration: 09/06/2011
• Prospective Registration: Yes
• Primary sponsor: GlaxoSmithKline
• Public title: A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD) AC4115321
• Scientific title: A Randomized, Double Blind, Placebo Controlled, Incomplete Block, Crossover, Dose Ranging Study to Evaluate the Dose Response of GSK573719 Administered Once or Twice Daily Over 7 Days in Patients With Chronic Obstructive Pulmonary Disease (COPD)
• Date of first enrolment: July 1, 2011
• Target sample size: 163
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT01372410
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Crossover Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 2

Countries of recruitment

United States

Contacts

• Name: GSK Clinical Trials
• Affiliation: GlaxoSmithKline

Key inclusion & exclusion criteria

Inclusion Criteria:

- Outpatient

- A signed and dated written informed consent prior to study participation.

- Male or female adults.

- 40 to 80 years of age at Visit 1

- Diagnosis of COPD

- Current or former cigarette smokers with a history of cigarette smoking of greater
than or equal to 10 pack-years

- Post-albuterol forced expiratory volume in 1 second (FEV1)/ forced vital capacity
(FVC)<0.70 and post albuterol FEV1 of greater than or equal to 35% and less than or
equal to 70% of predicted normal values

Exclusion Criteria:

- Women who are pregnant or lactating or are planning on becoming pregnant during the
study.

- A current diagnosis of asthma

- Known alpha-1 antitrypsin deficiency, active lung infections (such as tuberculosis),
and lung cancer

- Other significant respiratory conditions in addition to COPD

- Other diseases that are uncontrolled including cancer in remission for less than 5
years

- Chest x-ray or CT scan with clinically significant abnormalities not believed to be
due to the presence of COPD

- Hypersensitivity to any anticholinergic/muscarinic receptor antagonist, beta2-agonist,
lactose/milk protein or magnesium stearate

- A medical condition that contraindicates study participation or use of an inhaled
anticholinergic

- Hospitalization for COPD or pneumonia within 12 weeks of Visit 1

- Any previous lung resection surgery

- A body mass index (BMI) value of >35 kilogram (kg)/meter squared (m2)

- An abnormal and significant electrocardiogram finding at Visit 1

- Significantly abnormal finding from clinical chemistry or haematology tests at Visit
1.

- A positive Hepatitis B surface antigen or positive Hepatitis C antibody

- Medically unable to withhold albuterol (salbutamol) for the 6 hour period prior to
study visits

- Use of depot corticosteroids within 12 weeks of Visit 1

- Use of oral or parenteral corticosteroids or antibiotics for lower respiratory tract
infection within 6 weeks of Visit 1

- Use of long-acting beta-agonist (LABA)/inhaled corticosteroid (ICS) product if
LABA/ICS therapy is discontinued within 30 days of Visit 1

- Use of ICS at a dose of >1000mcg/day of fluticasone propionate or equivalent within 30
days of Visit 1

- Initiation or discontinuation of ICS within 30 days of Visit 1

- Use of tiotropium or phosphodiesterase 4 inhibitors within 14 days of Visit 1

- Use of theophyllines, oral leukotriene inhibitors, long-acting oral beta-agonists, or
inhaled long-acting beta-agonists within 48 hours of Visit 1

- Short-acting oral beta-agonists within 12 hours of Visit 1

- Use of LABA/ICS combination products only if discontinuing LABA therapy and switching
to ICS monotherapy within 48 hours of Visit 1 for the LABA component

- Use of sodium cromoglycate or nedocromil sodium within 24 hours of Visit 1

- Use of inhaled short-acting beta-agonists, inhaled short-acting anticholinergics, or
inhaled short-acting anticholinergic/short-acting beta-agonist combination products
within 6 hours of Visit 1

- Use of any other investigational medication within 30 days or 5 drug half-lives
(whichever is longer)

- Oxygen therapy prescribed for greater than 12 hours a day

- Regular use (prescribed for use every day, not for as-needed use) of short-acting
bronchodilators

- Use of continuous positive airway pressure (CPAP), nocturnal positive pressure or
non-invasive positive pressure ventilation (NIPPV), including use for sleep apnea.

- Acute phase of a pulmonary rehabilitation program within 4 weeks prior to Visit 1

- A known or suspected history of alcohol or drug abuse within 2 years prior to Visit 1

- Anyone affiliated with investigator site

- Previous use of GSK573719 or GSK53719/GW642444



Age minimum: 40 Years
Age maximum: 80 Years
Gender: All

Health Condition(s) or Problem(s) studied

Pulmonary Disease, Chronic Obstructive

Intervention(s)

Drug: Tiotropium

Drug: GSK573719

Drug: Placebo

Primary Outcome(s)

Change From Baseline in Trough Forced Expiratory Volume in One Second (FEV1) on Day 8 of Each Treatment Period [Time Frame: Baseline and Day 8 of each treatment period (up to Study Day 50)]

Final Dose-response Model Parameter ß-FEV1MB-S0 for Trough FEV1 [Time Frame: Day 7 and Day 8 of each treatment period (up to Study Day 50)]

Final Dose-response Model for Trough Forced Expiratory Volume in One Second (FEV1) [Time Frame: Day 7 and Day 8 of each treatment period (up to Study Day 50)]

Final Dose-response Model for Trough FEV1 for ED50 (Potency) Parameter [Time Frame: Day 7 and Day 8 of each treatment period (up to Study Day 50)]

Secondary Outcome(s)

Change From Baseline (BL) in Serial FEV1 Over Time on Day 7 of Each Treatment Period [Time Frame: Baseline and Day 7 of each treatment period (TP; up to Study Day 49)]

Change From Baseline (BL) in Weighted Mean FEV1 Over 0 to 24 Hours After the Morning Dosing on Day 7 of Each Treatment Period [Time Frame: Baseline and Day 7 of each treatment period (TP; up to Study Day 49)]

Secondary ID(s)

115321

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/02/2014
• URL: https://clinicaltrials.gov/ct2/show/results/NCT01372410