Phase 4
Completed N=56
A Study to Look at Day to Day Changes in Lung Function in COPD Subjects Taking Albuterol/Salbutamol and Ipratropium
Pulmonary Disease, Chronic Obstructive
Source: ClinicalTrials.gov NCT01691482 ↗
Enrolled (actual)
56
Serious AEs
1.8%
Results posted
Dec 2013
Primary outcomePrimary: Variability in Daily FEV1, Estimated by Coefficient of Variation — 0.081; 0.079; 0.059; NA Liters
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Variability in Daily FEV1, Estimated by Coefficient of Variation |
0.081; 0.079; 0.059; NA; 0.054; NA | — |
| PRIMARY Variability in Daily FEV1, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum Values) |
0.136; 0.135; 0.125; NA; 0.122; NA | — |
| SECONDARY The Maximal Bronchodilator Response for the First Administered Agent |
0.269; 0.243; 0.094; 0.094; 0.363; 0.337 | — |
| SECONDARY Percentage of Days for Which Participants Achieved a >=12% and 200 Milliliter (mL) Increase From Baseline in FEV1 |
58.4; NA; 71.7; NA; NA; 55.4 | — |
| SECONDARY Percentage of Days for Which Participants Achieved a Threshold Increase From Baseline in FEV1 of 100 mL, 200 mL, and 250 mL |
81.6; NA; 85.2; NA; NA; 72.9 | — |
| SECONDARY Variability in Daily Inspiratory Capacity (IC), Estimated by Coefficient of Variation |
0.078; 0.083; 0.069; NA; 0.070; NA | — |
| SECONDARY Variability in Daily IC, Estimated by Half Range (i.e., Half the Difference Between Maximum and Minimum) |
0.225; 0.236; 0.229; NA; 0.233; NA | — |
Eligibility 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 =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
Data sourced from ClinicalTrials.gov (NCT01691482). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.