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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Albuterol/salbutamol | Drug | Albuterol/salbutamol (daily) |
| |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Spartanburg | South Carolina | 29303 | United States | ||
| GSK Investigational Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25197005 | Derived | 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. |
| Label | URL |
|---|---|
| Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research. | View source |
| ID | Type | URL | Comment |
|---|---|---|---|
| 114956 | Statistical Analysis Plan | View IPD |
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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This was a randomized, open-label, two-period cross-over study to evaluate the daily bronchodilator response to albuterol/salbutamol and ipratropium individually and in combination in participants with chronic obstructive pulmonary disease.
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| ID | Title | Description |
|---|---|---|
| FG000 | A/S Then Ipratropium in TP1; Ipratropium Then A/S in TP2 | Participants received albuterol (4 puffs; 90 micrograms [µg] per puff)/salbutamol (A/S) (4 puffs; 100 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via a metered-dose inhaler (MDI) during treatment period 1 (TP1) then, ipratropium followed by A/S at the same doses via an MDI in treatment period 2 (TP2). |
| FG001 | Ipratropium Then A/S in TP1; A/S Then Ipratropium in TP2 | Participants received Ipratropium (4 puffs; 20 µg per puff) followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) (A/S) via a MDI in TP1, then A/S followed by ipratropium at the same doses via an MDI in TP2. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Treatment Period 1 |
| |||||||||||||
| Treatment Period 2 |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | All Randomized Participants | All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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 | Posted | Mean | Standard Error | Liters | up to 10 days |
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Randomized Participants | All participants randomized to receive a sequence of either salbutamol (4 puffs; 100 µg per puff) via an MDI and albuterol (4 puffs; 90 µg per puff) followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in TP1 and the same dose of each bronchodilator given in the opposite order in TP2, or ipratropium followed by albuterol/salbutamol in TP1 and the same dose of each bronchodilator given in the opposite order in TP2 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Death | General disorders | MedDRA | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | MedDRA | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| GSK Response Center | GlaxoSmithKline | 866-435-7343 |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| ID | Term |
|---|---|
| D000420 | Albuterol |
| D009241 | Ipratropium |
| ID | Term |
|---|---|
| D004983 | Ethanolamines |
| D000605 | Amino Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
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| Ipratropium |
| Drug |
Ipratropium (daily) |
|
| 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). | 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). | 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. | 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. | up to 10 days |
| Manchester |
| M23 9LT |
| United Kingdom |
For additional information about this study please refer to the GSK Clinical Study Register |
| 114956 | Dataset Specification | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114956 | Clinical Study Report | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114956 | Annotated Case Report Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114956 | Informed Consent Form | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114956 | Study Protocol | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| 114956 | Individual Participant Data Set | View IPD | For additional information about this study please refer to the GSK Clinical Study Register |
| NOT COMPLETED |
|
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Number | participants |
|
| ID | Title | Description |
|---|
| OG000 | Albuterol/Salbutamol Followed by Ipratropium | All participants randomized to receive a sequence of albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI followed by ipratropium (4 puffs; 20 µg per puff) via an MDI in either TP1 or TP2. |
| OG001 | Ipratropium Followed by Albuterol/Salbutamol | All participants randomized to receive a sequence of ipratropium (4 puffs; 20 µg per puff) via an MDI followed by albuterol (4 puffs; 90 µg per puff)/salbutamol (4 puffs; 100 µg per puff) via an MDI in either TP1 or TP2 |
|
|
|
| Secondary | 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. | Efficacy Population | Posted | Least Squares Mean | Standard Error | Liters | up to 10 days |
|
|
|
| Secondary | 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). | Efficacy Population | Posted | Mean | Standard Deviation | percentage of days | up to 35 days |
|
|
|
| Secondary | 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). | Efficacy Population | Posted | Mean | Standard Deviation | percentage of days | up to 35 days |
|
|
|
| Primary | 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. | Efficacy Population | Posted | Mean | Standard Error | Liters | up to 10 days |
|
|
|
|
| Secondary | 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. | Efficacy Population | Posted | Mean | Standard Deviation | Liters | up to 10 days |
|
|
|
|
| Secondary | 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. | Efficacy Population | Posted | Mean | Standard Deviation | Liters | up to 10 days |
|
|
|
|
| 1 |
| 56 |
| 16 |
| 56 |
| Dizziness | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Dysgeusia | Nervous system disorders | MedDRA | Systematic Assessment |
|
| Cough | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Increased upper airway secretion | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Painful respiration | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Sneezing | Respiratory, thoracic and mediastinal disorders | MedDRA | Systematic Assessment |
|
| Abdominal pain upper | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA | Systematic Assessment |
|
| Chest discomfort | General disorders | MedDRA | Systematic Assessment |
|
| Influenza like illness | General disorders | MedDRA | Systematic Assessment |
|
| Oedema peripheral | General disorders | MedDRA | Systematic Assessment |
|
| Excoriation | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Fall | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Muscle strain | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Radius fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Tooth fracture | Injury, poisoning and procedural complications | MedDRA | Systematic Assessment |
|
| Bacterial infection | Infections and infestations | MedDRA | Systematic Assessment |
|
| Herpes zoster | Infections and infestations | MedDRA | Systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Rhinitis | Infections and infestations | MedDRA | Systematic Assessment |
|
| Back pain | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Joint swelling | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Muscle spasms | Musculoskeletal and connective tissue disorders | MedDRA | Systematic Assessment |
|
| Haematuria | Renal and urinary disorders | MedDRA | Systematic Assessment |
|
GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.
| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D000588 |
| Amines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D001286 | Atropine Derivatives |
| D014326 | Tropanes |
| D053961 | Azabicyclo Compounds |
| D001372 | Aza Compounds |
| D001533 | Belladonna Alkaloids |
| D012991 | Solanaceous Alkaloids |
| D000470 | Alkaloids |
| D006571 | Heterocyclic Compounds |
| D019086 | Bridged Bicyclo Compounds, Heterocyclic |
| D006572 | Heterocyclic Compounds, Bridged-Ring |
| Title | Measurements |
|---|---|
|
| Second agent, ipratropium |
|
| A/S followed by ipratropium |
|
| Ipratropium followed by A/S |
|
| Ipratropium alone, 1 hour |
|
| Ipratropium followed by A/S, 2 hours |
|
| Ipratropium alone, 1 hour, 100 mL |
|
| Ipratropium followed by A/S, 2 hours, 100 mL |
|
| A/S alone, 1 hour, 200 mL |
|
| A/S followed by ipratropium, 2 hours, 200 mL |
|
| Ipratropium alone, 1 hour, 200 mL |
|
| Ipratropium followed by A/S, 2 hours, 200 mL |
|
| A/S alone, 1 hour, 250 mL |
|
| A/S followed by ipratropium, 2 hours, 250 mL |
|
| Ipratropium alone, 1 hour, 250 mL |
|
| Ipratropium followed by A/S, 2 hours, 250 mL |
|
| A/S followed by ipratropium, 2 hours |
|
| Ipratropium alone, 1 hour |
|
| Ipratropium followed by A/S, 2 hours |
|
| Adjusted Mean |
| 0.071 |
| Standard Error of the Mean |
| 0.0046 |
| 95 |
| 0.062 |
| 0.080 |
Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used. |
| Superiority or Other |
| Adjusted Mean | 0.053 | Standard Error of the Mean | 0.0046 | 95 | 0.044 | 0.062 | Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used. | Superiority or Other |
| Adjusted Mean | 0.062 | 95 | 0.053 | 0.071 | Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), FEV1 Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used. | Superiority or Other |
| A/S followed by ipratropium (A+I), 2 hours |
|
| Ipratropium alone, 1 hour |
|
| Ipratropium followed by A/S (I+A), 2 hours |
|
| Adjusted Mean |
| 0.070 |
| Standard Error of the Mean |
| 0.0045 |
| 95 |
| 0.061 |
| 0.079 |
Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used. |
| Superiority or Other |
| Adjusted Mean | 0.069 | Standard Error of the Mean | 0.0045 | 95 | 0.060 | 0.078 | Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used. | Superiority or Other |
| Adjusted Mean | 0.064 | Standard Error of the Mean | 0.0045 | 95 | 0.055 | 0.073 | Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used. | Superiority or Other |
| A/S followed by ipratropium, 2 hours |
|
| Ipratropium alone, 1 hour |
|
| Ipratropium followed by A/S, 2 hours |
|
| Adjusted Mean |
| 0.231 |
| Standard Error of the Mean |
| 0.0140 |
| 95 |
| 0.203 |
| 0.258 |
Treatment: ipratropium alone. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used. |
| Superiority or Other |
| Adjusted Mean | 0.232 | Standard Error of the Mean | 0.0140 | 95 | 0.204 | 0.259 | Treatment: A+I. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used. | Superiority or Other |
| Adjusted Mean | 0.217 | Standard Error of the Mean | 0.0140 | 95 | 0.190 | 0.245 | Treatment: I+A. A mixed model analysis, with period, treatment (A+I, I+A, Albuterol alone, Ipratropium alone), IC Baseline, smoking status at Screening, and center fitted as fixed effects and participant as a random effect was used. | Superiority or Other |