Who is sponsoring NCT01691482?

NCT01691482 is sponsored by GlaxoSmithKline.

What drugs are being tested in NCT01691482?

Interventions in NCT01691482: Albuterol/salbutamol, Ipratropium.

What condition does NCT01691482 study?

NCT01691482 studies Pulmonary Disease, Chronic Obstructive.

Is NCT01691482 still recruiting?

NCT01691482 is currently completed. Last updated 20 June 2018.

Are results published for NCT01691482?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-06-20 · How we verify

NCT01691482

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

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

Completed Phase 4 Results posted Last updated 20 June 2018

What this trial tests

Phase 4 trial testing Albuterol/salbutamol in Pulmonary Disease, Chronic Obstructive in 56 participants. Completed in 22 October 2012.

Timeline

23 July 2012

Primary endpoint
1 October 2012

22 October 2012

Quick facts

Lead sponsor	GlaxoSmithKline
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	crossover
Masking	none
Primary purpose	treatment
Enrollment	56
Start date	23 July 2012
Primary completion	1 October 2012
Estimated completion	22 October 2012
Sites	2 locations across United Kingdom, United States

Drugs / interventions tested

Albuterol/salbutamol — full drug profile →
Ipratropium (IPRATROPIUM) — full drug profile →

Conditions studied

Pulmonary Disease, Chronic Obstructive — all drugs for Pulmonary Disease, Chronic Obstructive →

Sponsor

GlaxoSmithKline — full company profile →

Who can join

40 and older, any sex, with Pulmonary Disease, Chronic Obstructive. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Variability in Daily FEV1, Estimated by Coefficient of Variation Primary · 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

Pre-dose/non-bronchodilator

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.081	± 0.0394
Ipratropium Followed by Albuterol/Salbutamol	0.079	± 0.0372

Albuterol/Salbutamol (A/S) alone, 1 hour

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.059	± 0.0276
Ipratropium Followed by Albuterol/Salbutamol	NA	± NA

A/S followed by ipratropium, 2 hours

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.054	± 0.0232
Ipratropium Followed by Albuterol/Salbutamol	NA	± NA

Ipratropium alone, 1 hour

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Followed by Albuterol/Salbutamol	0.072	± 0.0406

Ipratropium followed by A/S, 2 hours

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Followed by Albuterol/Salbutamol	0.063	± 0.0327

The Maximal Bronchodilator Response for the First Administered Agent Secondary · up to 10 days

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-administratio

First agent, albuterol/salbutamol (A/S)

Group	Value	95% CI
All Randomized Participants	0.269	± 0.0174

First agent, ipratropium

Group	Value	95% CI
All Randomized Participants	0.243	± 0.0174

Second agent, A/S

Group	Value	95% CI
All Randomized Participants	0.094	± 0.0123

Second agent, ipratropium

Group	Value	95% CI
All Randomized Participants	0.094	± 0.0123

A/S followed by ipratropium

Group	Value	95% CI
All Randomized Participants	0.363	± 0.0200

Ipratropium followed by A/S

Group	Value	95% CI
All Randomized Participants	0.337	± 0.0200

Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1 Secondary · up to 35 days

Albuterol/Salbutamol (A/S) alone, 1 hour

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	58.4	± 38.26
Ipratropium Follwed by Albuterol/Salbutamol	NA	± NA

A/S followed by ipratropium, 2 hours

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	71.7	± 35.51
Ipratropium Follwed by Albuterol/Salbutamol	NA	± NA

Ipratropium alone, 1 hour

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Follwed by Albuterol/Salbutamol	55.4	± 39.34

Ipratropium followed by A/S, 2 hours

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Follwed by Albuterol/Salbutamol	69.1	± 36.82

Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL Secondary · up to 35 days

A/S alone, 1 hour, 100 mL

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	81.6	± 31.35
Ipratropium Follwed by Albuterol/Salbutamol	NA	± NA

A/S followed by ipratropium, 2 hours, 100 mL

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	85.2	± 29.92
Ipratropium Follwed by Albuterol/Salbutamol	NA	± NA

Ipratropium alone, 1 hour, 100 mL

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Follwed by Albuterol/Salbutamol	72.9	± 38.06

Ipratropium followed by A/S, 2 hours, 100 mL

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Follwed by Albuterol/Salbutamol	81.2	± 33.46

A/S alone, 1 hour, 200 mL

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	59.2	± 38.20
Ipratropium Follwed by Albuterol/Salbutamol	NA	± NA

A/S followed by ipratropium, 2 hours, 200 mL

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	72.7	± 35.25
Ipratropium Follwed by Albuterol/Salbutamol	NA	± NA

Ipratropium alone, 1 hour, 200 mL

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Follwed by Albuterol/Salbutamol	56.0	± 39.54

Ipratropium followed by A/S, 2 hours, 200 mL

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Follwed by Albuterol/Salbutamol	70.5	± 36.23

Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values) Primary · up to 10 days

Pre-dose/non-bronchodilator

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.136	± 0.0627
Ipratropium Followed by Albuterol/Salbutamol	0.135	± 0.0780

Albuterol/Salbutamol (A/S) alone, 1 hour

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.125	± 0.0525
Ipratropium Followed by Albuterol/Salbutamol	NA	± NA

A/S followed by ipratropium, 2 hours

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.122	± 0.0542
Ipratropium Followed by Albuterol/Salbutamol	NA	± NA

Ipratropium alone, 1 hour

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Followed by Albuterol/Salbutamol	0.145	± 0.0805

Ipratropium followed by A/S, 2 hours

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Followed by Albuterol/Salbutamol	0.137	± 0.0726

Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation Secondary · up to 10 days

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 measur

Pre-dose/non-bronchodilator

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.078	± 0.0305
Ipratropium Followed by Albuterol/Salbutamol	0.083	± 0.0374

Albuterol/Salbutamol (A/S) alone, 1 hour

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.069	± 0.0310
Ipratropium Followed by Albuterol/Salbutamol	NA	± NA

A/S followed by ipratropium (A+I), 2 hours

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.070	± 0.0373
Ipratropium Followed by Albuterol/Salbutamol	NA	± NA

Ipratropium alone, 1 hour

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Followed by Albuterol/Salbutamol	0.072	± 0.0353

Ipratropium followed by A/S (I+A), 2 hours

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Followed by Albuterol/Salbutamol	0.066	± 0.0307

Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum) Secondary · up to 10 days

Pre-dose/non-bronchodilator

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.225	± 0.1017
Ipratropium Followed by Albuterol/Salbutamol	0.236	± 0.1166

Albuterol/Salbutamol (A/S) alone, 1 hour

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.229	± 0.1004
Ipratropium Followed by Albuterol/Salbutamol	NA	± NA

A/S followed by ipratropium, 2 hours

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	0.233	± 0.1132
Ipratropium Followed by Albuterol/Salbutamol	NA	± NA

Ipratropium alone, 1 hour

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Followed by Albuterol/Salbutamol	0.235	± 0.1026

Ipratropium followed by A/S, 2 hours

Group	Value	95% CI
Albuterol/Salbutamol Followed by Ipratropium	NA	± NA
Ipratropium Followed by Albuterol/Salbutamol	0.221	± 0.1066

Adverse events — posted to ClinicalTrials.gov

Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

All Randomized Participants

Serious: 1/56 (2%)

Deaths: —

Serious adverse events (1 terms)

Reaction	System	All Randomized Participants
Death	General disorders	—

Other adverse events (28 terms — click to expand)

Reaction	System	All Randomized Participants
Headache	Nervous system disorders	—
Dizziness	Nervous system disorders	—
Dysgeusia	Nervous system disorders	—
Cough	Respiratory, thoracic and mediastinal disorders	—
Epistaxis	Respiratory, thoracic and mediastinal disorders	—
Increased upper airway secretion	Respiratory, thoracic and mediastinal disorders	—
Painful respiration	Respiratory, thoracic and mediastinal disorders	—
Sneezing	Respiratory, thoracic and mediastinal disorders	—
Abdominal pain upper	Gastrointestinal disorders	—
Diarrhoea	Gastrointestinal disorders	—
Toothache	Gastrointestinal disorders	—
Vomiting	Gastrointestinal disorders	—
Chest discomfort	General disorders	—
Influenza like illness	General disorders	—
Oedema peripheral	General disorders	—
Excoriation	Injury, poisoning and procedural complications	—
Fall	Injury, poisoning and procedural complications	—
Muscle strain	Injury, poisoning and procedural complications	—
Radius fracture	Injury, poisoning and procedural complications	—
Tooth fracture	Injury, poisoning and procedural complications	—
Bacterial infection	Infections and infestations	—
Herpes zoster	Infections and infestations	—
Nasopharyngitis	Infections and infestations	—
Rhinitis	Infections and infestations	—
Back pain	Musculoskeletal and connective tissue disorders	—
Joint swelling	Musculoskeletal and connective tissue disorders	—
Muscle spasms	Musculoskeletal and connective tissue disorders	—
Haematuria	Renal and urinary disorders	—

Most-reported serious reactions: Death.

Data from ClinicalTrials.gov NCT01691482 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

Bronchodilator reversibility in patients with COPD revisited: short-term reproducibility.
Pascoe S, Wu W, Zhu CQ, Singh D. · · 2016 · cited 7× · PMID 27621609 · DOI 10.2147/copd.s108723
Daily variation in lung function in COPD patients with combined albuterol and ipratropium: results from a 4-week, randomized, crossover study.
Singh D, Zhu CQ, Sharma S, Church A, et al · · 2015 · cited 5× · PMID 25197005 · DOI 10.1016/j.pupt.2014.08.010

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT01691482 (US National Library of Medicine, public domain)
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
Last refreshed: 20 June 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01691482.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing

NCT01691482

Quick facts

Drugs / interventions tested

Conditions studied

Sponsor

Who can join

Results — posted to ClinicalTrials.gov

Adverse events — posted to ClinicalTrials.gov

Serious adverse events (1 terms)

Sponsor's own description

Publications & conference data

Related trials

Other trials of Albuterol/salbutamol

Other recruiting trials for Pulmonary Disease, Chronic Obstructive

Other GlaxoSmithKline trials

Verify against primary sources