A Study to Look at Day to Day Changes in Lung Function in COPD Subjects Taking Albuterol/Salbutamol and Ipratropium

NCT01691482 | Completed Phase 4 Results

• 1 other identifier: 114956
• Study Type: interventional
• Target: 56
• Locations: 2 countries
• Sites: 2

Brief Summary

The objective of this study is to assess the daily variation in bronchodilator response to an inhaled short acting beta2-agonist (albuterol/salbutamol) and an inhaled short acting anticholinergic (ipratropium) individually and when used in combination in subjects with COPD.

Conditions

Pulmonary Disease, Chronic Obstructive

Outcome Measures

Primary Outcomes (2)

• Variability in Daily FEV1, Estimated by Coefficient of Variation

  FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is the difference between the maximum and minimum FEV1 values.

  up to 10 days

• Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)

  FEV1 is the maximal amount of air that can be forcefully exhaled in one second. During each study period, pre- and post-bronchodilator spirometry for evaluation of FEV1 was performed at study visits as follows: prior to administration of the first short-acting bronchodilator, approximately 1 hour after administration of the first bronchodilator (1 hour), and approximately 1 hour after administration of the second short-acting bronchodilator (2 hours). Variability in daily FEV1 was measured as the fluctuation around the mean FEV1 data collected from Day 1 to Day 10. Variability was measured by the coefficient of variation (CV) and the half range. The CV is the dispersion of the data around the mean, whereas the half range method is half the difference between the maximum and minimum FEV1 values.

  up to 10 days

Secondary Outcomes (5)

• The Maximal Bronchodilator Response for the First Administered Agent

  up to 10 days

• Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1

  up to 35 days

• Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL

  up to 35 days

• Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation

  up to 10 days

• Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)

  up to 10 days

Study Arms (2)

Albuterol/salbutamol followed by ipratropium

ACTIVE COMPARATOR

Subjects will recieve daily albuterol/salbutamol followed by ipratropium which will be adminstered one hour after adminstration of albuterol/salbutamol

Drug: Albuterol/salbutamol

Ipratropium followed by albuterol/salbutamol

ACTIVE COMPARATOR

Subjects will recieve daily ipratropium followed by albuterol/salbutamol which will be adminstered one hour after adminstration of ipratropium

Drug: Ipratropium

Interventions

Albuterol/salbutamol DRUG

Albuterol/salbutamol (daily)

Albuterol/salbutamol followed by ipratropium

Ipratropium DRUG

Ipratropium (daily)

Ipratropium followed by albuterol/salbutamol

Eligibility Criteria

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

You may qualify if:

• Subjects must give their signed and dated written informed consent to participate.
• Subjects 40 years of age or older at Visit 1.
• Male or female subjects .
• An established clinical history of COPD.
• Current or former cigarette smokers with a history of cigarette smoking of \>=10 pack-years at Visit 1.
• A post-albuterol/salbutamol FEV1/FVC ratio of \<0.70 and a post-albuterol/salbutamol FEV1 of \>=30 and \<= 70% of predicted normal values at Visit 1 calculated using NHANES III reference equations .

You may not qualify if:

• A current diagnosis of asthma
• Women who are pregnant of lactating or are planning on becoming pregnant during the study.
• Hospitalization for COPD or pneumonia within 12 weeks prior to Visit 1.
• Participation in pulmonary rehabilitation

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (2)

GSK Investigational Site

Spartanburg, South Carolina, 29303, United States

Location

GSK Investigational Site

Manchester, M23 9LT, United Kingdom

Location

Related Publications (1)

• Singh D, Zhu CQ, Sharma S, Church A, Kalberg CJ. Daily variation in lung function in COPD patients with combined albuterol and ipratropium: results from a 4-week, randomized, crossover study. Pulm Pharmacol Ther. 2015 Apr;31:85-91. doi: 10.1016/j.pupt.2014.08.010. Epub 2014 Sep 6.

  PMID: 25197005 DERIVED

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

Albuterol; Ipratropium

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)

Ethanolamines; Amino Alcohols; Alcohols; Organic Chemicals; Amines; Phenethylamines; Ethylamines; Atropine Derivatives; Tropanes; Azabicyclo Compounds; Aza Compounds; Belladonna Alkaloids; Solanaceous Alkaloids; 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 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 20, 2012
• First Posted: September 24, 2012
• Study Start: July 23, 2012
• Primary Completion: October 1, 2012
• Study Completion: October 22, 2012
• Last Updated: June 20, 2018
• Results First Posted: December 25, 2013

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will share

Locations

GB (1); US (1)