Change of Inspiratory Peak Flow in COPD
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|ClinicalTrials.gov Identifier: NCT00561886|
Recruitment Status : Completed
First Posted : November 21, 2007
Last Update Posted : November 21, 2007
|Condition or disease||Intervention/treatment||Phase|
|Chronic Obstructive Pulmonary Disease||Drug: Formoterol||Phase 4|
N=40 patients with moderate to severe COPD (30 < FEV1 < 70 % pred.), no further significant lung disease; current smokers or ex-smokers; no exacerbation in the last 2 month.
Baseline visit Physical examination Dsypnea score (Borg-Scale, TDI) Lung function (Bodyplethysmography, CO-diffusion capacity)
Before each study day the following medication will be withheld:
Short-acting bronchodilators > 6 hours Long-acting b2-adrenoceptor agonist > 24 hours Tiotropium > 24 hours
Study day 1 Bodyplethysmography including FEV1, PEF, FIV1 and PIF and assessment of PIF using an inspiratory Peak Flow Meter in randomized order.
Dysnpea Scores 30 minute break Assessment of change in dyspnea (visual analogue scale) Bodyplethysmography including FEV1, PEF, FIV1 and PIF. Assessment of PIF using an inspiratory Peak Flow Meter in randomized order Administration of 12 µg formoterol 30 minute break Assessment of change in dyspnea (visual analogue scale) Bodyplethysmography including FEV1, PEF, FIV1 and PIF. Assessment of PIF using an inspiratory Peak Flow Meter in randomized order.
Study day 2 Three to 14 days following study day 1. Schedule like day 1 with change in the order of lung function testing depending on randomization.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||40 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Change of Inspiratory Peak Flow After Bronchial Dilatation on Patients With Moderate to Severe COPD|
|Study Start Date :||April 2007|
|Actual Study Completion Date :||October 2007|
Patients with COPD receiving once 24 µg formoterol
One inhalation of 24µg Formoterol
- Change in inspiratory peak flow following administration of a bronchodilator assessed by inspiratory peak flow device in patients with moderate to sever COPD [ Time Frame: October 2007 ]
- Correlation of changes in FEV1, FIV1 and PIF following bronchodilation in spirometry [ Time Frame: October 2007 ]
- Correlation of change in PIF and symptomatic improvement in patients with COPD following bronchodilatation [ Time Frame: October 2007 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00561886
|Principal Investigator:||Roland Buhl, MD||Johannes Gutenberg University Mainz|