The aim of the study is to investigate whether the early introduction of maintenance bronchodilator therapy during an acute symptomatic episode of the disease shows benefits on the recovery of symptoms. It also represents an opportunity to identify COPD patients earlier in their disease state and start maintenance therapy, if appropriate.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
140
18mcg
placebo
Trough FEV1 After 12 Weeks on Study Drug
The primary endpoint was trough forced expiratory volume in 1 second (FEV1) after 12 weeks on study drug. Trough forced expiratory volume in 1 second (FEV1)was defined as the FEV1 measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.
Time frame: 12 weeks
Time to Recovery From Acute Respiratory Symptoms
Time to recovery was assessed with the EXACT-PRO questionnaire tool. The EXACT-PRO was designed to collect data to quantify frequency, severity, and duration of exacerbations in patients with COPD including the onset of and the recovery from COPD exacerbations. The EXACT-PRO is a 14-item questionnaire. Each attribute or item was assessed on a five- or six-point ordinal scale and summed to yield a total score that was converted to a 0-100 scale, with higher scores indicating a more severe health state or exacerbation. The EXACT-PRO was answered by the patients on a daily basis in the evening.
Time frame: 12 weeks
Trough FVC (in Litres) at 12 Weeks
The trough Forced Vital Capacity (FVC) was defined as the FVC measurement prior to the next dosing of study drug and approximately 24 hours after the last inhalation of study drug.
Time frame: 12 weeks
Responder Status at Week 4 Clinic Visit
Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented: * Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included). * Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1). * Subject did not recover.
Time frame: 4 weeks
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Responder Status at Week 12 Clinic Visit
Responder status was determined at each clinic visit. The number and percentage of subjects in each of the following 3 classes were presented: * Subject recovered without change of therapy (subjects who received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1 were not included). * Subject recovered but had a change in therapy (subject received an additional course of antibiotics and/or systemic corticosteroids starting after Visit 1). * Subject did not recover.
Time frame: 12 weeks
Weekly Rescue Medication Use Over the 12 Weeks of Study
Daily rescue albuterol use was recorded in the diary in response to the following question: How many puffs of rescue medication did you use during the last 24 hours? The weekly rescue medication use was derived by summing the daily uses over the 12 weeks and dividing this total by 12 weeks.
Time frame: 12 weeks