Pulmonary Disease, Chronic ObstructivePhase 4NCT01691482

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

A Phase 4 study testing Albuterol/salbutamol and Ipratropium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 2 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Pulmonary Disease, Chronic Obstructive
What is being tested?: Albuterol/salbutamol and Ipratropium
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 56 participants
Where: 2 sitesin 2 countries
Study dates: 23 Jul 2012to 22 Oct 2012
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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 .

Who cannot join

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

Trial locations and contacts

2 sites in 2 countries.

Country

City, postcode or hospital

2 sites in 2 countries

United States1 site

GSK Investigational Site
Spartanburg, South Carolina, 29303

Other trials in United States

United Kingdom1 site

GSK Investigational Site
Manchester, M23 9LT

Other trials in United Kingdom

About this study

Official title: A 4-Week Randomized Cross-Over Study to Evaluate Daily Lung Function Following the Administration of Albuterol/Salbutamol and Ipratropium in Subjects With Chronic Obstructive Pulmonary Disease

Read the detailed description

Beta2-agonist and anticholinergics are a principle component of the pharmacologic management of chronic obstructive pulmonary disease COPD. It has been demonstrated that the combination of a short acting beta2-agonist and a short acting anticholinergic yields greater efficacy as measured by FEV1 when compared with the response to the individual short acting bronchodilators. However, daily bronchial response to these agents is poorly understood. It is also poorly understood how the variation in magnitude of the response to the individual agents and how the variation in response for one agent coincides with the variation in response to the other agent. This study will seek to define the pattern of response of each individual agent and the relationship between them. The study will also explore if the combination of the two agents leads to less variation in response compared to the individual agents. This is a randomized, open label, two period cross-over study. Eligible subjects will be randomized to a sequence of either albuterol/salbutamol via metered-dose inhaler (MDI) followed by ipratropium via MDI or the same dose of each bronchodilator given in the opposite order. Each study period will consist of 10 clinic visits to be conducted over 10 to 14 days.

Conditions: Pulmonary Disease, Chronic Obstructive
Being tested: Albuterol/salbutamol, Ipratropium
Medical subject headings: Pulmonary Disease, Chronic Obstructive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Albuterol/salbutamolDrug
Albuterol/salbutamol (daily)
IpratropiumDrug
Ipratropium (daily)

Study groups in NCT01691482
Study group	Role	What they receive
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 Receives: 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 Receives: Drug: Ipratropium

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 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.
Measured: up to 10 days

Secondary outcomes (5)

The Maximal Bronchodilator Response for the First Administered Agent
The maximal bronchodilator response for the first administered agent is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) 1 hour post-dose of the first bronchodilator minus the pre-dose. The maximal bronchodilator response for the second agent is defined as the FEV1 1 hour post-dose of the second bronchodilator minus the FEV1 at 1 hour post-dose of the first bronchodilator. The maximal bronchodilator response for the combination is defined as the FEV1 (the maximal amount of air that can be forcefully exhaled in one second) at 1 hour post-administration of the second bronchodilator minus the corresponding pre-dose FEV1. Derived FEV1 response is FEV1 change from 0 hours (0H) for the first agent assessment (at 1 hour [1H]); change from 1H for the second agent assessment (at 2 hours [2H]); and change from 0H for the combination assessment (at 2H). Data were adjusted for FEV1, smoking status, and center.
Measured: up to 10 days
Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1
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: 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).
Measured: 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
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: 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).
Measured: up to 35 days
Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation
IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC 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 IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent 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 IC values.
Measured: up to 10 days
Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)
IC is the the total amount of air that can be drawn into the lungs after normal expiration. During each study period, pre- and post-bronchodilator spirometry for evaluation of IC 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 IC was measured as the fluctuation around the mean IC data collected from Day 1 to Day 10. Variability was measured by the coefficent 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 IC values.
Measured: up to 10 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

23 Jul 201222 Oct 2012

First posted24 Sep 2012 (estimated)
Study start23 Jul 2012
Primary completion1 Oct 2012
Study completion22 Oct 2012

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Pulmonary Disease, Chronic ObstructiveStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Enrolment: 56 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01691482
Sponsor's protocol ID: 114956
Status last verified: Jun 2018
First submitted: 20 Sep 2012
Last updated: 20 Jun 2018
Results posted: Yes, on ClinicalTrials.gov
Individual data sharing: Yes: Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Publications

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.
PubMed 25197005

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 20 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A 4-Week Randomized Cross-Over Study to Evaluate Daily Lung Function Following the Administration of Albuterol/Salbutamol and Ipratropium in Subjects With Chronic Obstructive Pulmonary Disease
ClinicalTrials.gov ID: NCT01691482
Acronym / sponsor ID: 114956
Conditions: Pulmonary Disease, Chronic Obstructive
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 56 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: 23 Jul 2012
Primary completion: 1 Oct 2012 (actual)
Study completion: 22 Oct 2012 (actual)
First posted: 24 Sep 2012 (estimated)
Results: Posted 25 Dec 2013

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Crossover
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Albuterol/salbutamol followed by ipratropium	Active comparator	Drug: Albuterol/salbutamolSubjects will recieve daily albuterol/salbutamol followed by ipratropium which will be adminstered one hour after adminstration of albuterol/salbutamol
Ipratropium followed by albuterol/salbutamol	Active comparator	Drug: IpratropiumSubjects will recieve daily ipratropium followed by albuterol/salbutamol which will be adminstered one hour after adminstration of ipratropium

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

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.

Key exclusion criteria (4 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Albuterol/salbutamolAlbuterol/salbutamol (daily)	Drug	Albuterol/salbutamol followed by ipratropium
IpratropiumIpratropium (daily)	Drug	Ipratropium followed by albuterol/salbutamol

Primary outcome

Variability in Daily FEV1, Estimated by Coefficient of Variation
Time frame: up to 10 days
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.
Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values)
Time frame: up to 10 days
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.

5 secondary outcomes

The Maximal Bronchodilator Response for the First Administered Agent
Time frame: up to 10 days
Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1
Time frame: 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
Time frame: up to 35 days
Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation
Time frame: up to 10 days
Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum)
Time frame: up to 10 days

Results and safety

Results posted to the registry on 25 Dec 2013, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
A/S Then Ipratropium in TP1; Ipratropium Then A/S in TP2	28	28
Ipratropium Then A/S in TP1; A/S Then Ipratropium in TP2	28	28

Primary outcome: Variability in Daily FEV1, Estimated by Coefficient of Variation

Time frame: up to 10 days. Mean (Standard Error). Unit: Liters

Measure	Albuterol/Salbutamol Followed by Ipratropium n = 55	Ipratropium Followed by Albuterol/Salbutamol n = 55
Pre-dose/non-bronchodilator	0.081 (0.0394)	0.079 (0.0372)
Albuterol/Salbutamol (A/S) alone, 1 hour	0.059 (0.0276)	NA (NA)
A/S followed by ipratropium, 2 hours	0.054 (0.0232)	NA (NA)
Ipratropium alone, 1 hour	NA (NA)	0.072 (0.0406)
Ipratropium followed by A/S, 2 hours	NA (NA)	0.063 (0.0327)

Albuterol/Salbutamol Followed by Ipratropium: Adjusted Mean: 0.058 (95% CI 0.049 to 0.067)
Ipratropium Followed by Albuterol/Salbutamol: Adjusted Mean: 0.071 (95% CI 0.062 to 0.080)
Albuterol/Salbutamol Followed by Ipratropium: Adjusted Mean: 0.053 (95% CI 0.044 to 0.062)

Population analysed: Efficacy Population: participants in the Intent-to-Treat Population (all participants who were randomized and received at least one bronchodilator in the treatment period) who completed pre- and post- bronchodilator assessments for at least 17 visits, with no more than 3 consecutive missing days

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

Time frame: up to 10 days. Mean (Standard Error). Unit: Liters

Measure	Albuterol/Salbutamol Followed by Ipratropium n = 55	Ipratropium Followed by Albuterol/Salbutamol n = 55
Pre-dose/non-bronchodilator	0.136 (0.0627)	0.135 (0.0780)
Albuterol/Salbutamol (A/S) alone, 1 hour	0.125 (0.0525)	NA (NA)
A/S followed by ipratropium, 2 hours	0.122 (0.0542)	NA (NA)
Ipratropium alone, 1 hour	NA (NA)	0.145 (0.0805)
Ipratropium followed by A/S, 2 hours	NA (NA)	0.137 (0.0726)

Albuterol/Salbutamol Followed by Ipratropium: Adjusted Mean: 0.058 (95% CI 0.049 to 0.067)
Ipratropium Followed by Albuterol/Salbutamol: Adjusted Mean: 0.071 (95% CI 0.062 to 0.080)
Albuterol/Salbutamol Followed by Ipratropium: Adjusted Mean: 0.053 (95% CI 0.044 to 0.062)

Population analysed: Efficacy Population

5 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Randomized Participants	1 of 56 (1.8%)	16 of 56 (28.6%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 25197005Singh 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.
Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.Link provided by the sponsor.
Individual participant dataSharing planned: Yes. Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

2 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Albuterol/salbutamol and Ipratropium in people with Pulmonary Disease, Chronic Obstructive, run by GlaxoSmithKline at 2 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 25 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Variability in Daily FEV1, Estimated by Coefficient of Variation (time frame: up to 10 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01691482, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2018.