Last updated: 11/07/2018 08:26:20
A study to look at day to day changes in lung function in COPD subjects taking Albuterol/Salbutamol and Ipratropium
EudraCT ID
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
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
Trial 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.
Primary purpose:
Treatment
Trial design:
Crossover Assignment
Masking:
None (Open Label)
Allocation:
Randomized
Primary outcomes:
Variability in daily FEV1, estimated by coefficient of variation
Timeframe: up to 10 days
Variability in daily FEV1, estimated by half range (i.e., half the difference between maximum and minimum values)
Timeframe: up to 10 days
Secondary outcomes:
The maximal bronchodilator response for the first administered agent
Timeframe: up to 10 days
Percentage of days for which participants achieved a >=12% and 200 milliliter (mL) increase from Baseline in FEV1
Timeframe: 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
Timeframe: up to 35 days
Variability in daily inspiratory capacity (IC), estimated by coefficient of variation
Timeframe: up to 10 days
Variability in daily IC, estimated by half range (i.e., half the difference between maximum and minimum)
Timeframe: up to 10 days
Interventions:
Enrollment:
56
Primary completion date:
2012-22-10
Observational study model:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Singh D, Chang-Qing Zhu, Sharma S, Church A, Kalberg C. Daily variation in lung function in COPD patients with combined albuterol and ipratropium: results from a 4-week, randomized, crossover study. Pulm Pharmacol Ther. 2014;Epub ahead of print.
Medical condition
Pulmonary Disease, Chronic Obstructive
Product
ipratropium bromide, salbutamol
Collaborators
Not applicable
Study date(s)
July 2012 to October 2012
Type
Interventional
Phase
4
Participation criteria
Sex
Female & Male
Age
40+ years
Accepts healthy volunteers
No
- Subjects must give their signed and dated written informed consent to participate.
- Subjects 40 years of age or older at Visit 1.
- A current diagnosis of asthma
- Women who are pregnant of lactating or are planning on becoming pregnant during the study.
Inclusion and exclusion criteria
Inclusion criteria:
- 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 .
Exclusion criteria:
- 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 location(s)
Location
GSK Investigational Site
Spartanburg, South Carolina, United States, 29303
Status
Study Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
Protocol
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Study complete
Actual primary completion date
2012-22-10
Actual study completion date
2012-22-10
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
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