A Study to Look at Day to Day Changes in Lung Function in COPD Subjects Taking Albuterol/Salbutamol and Ipratropium

GlaxoSmithKline (GSK)

Status and phase: Completed; Phase 4

Conditions: Pulmonary Disease, Chronic Obstructive

Treatments: Drug: Albuterol/salbutamol; Drug: Ipratropium

Study type: Interventional

Funder types: Industry

Identifiers

NCT01691482

114956

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 56 patients

Sex: All

Ages: 40+ years old

Volunteers: No Healthy Volunteers

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 design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: None (Open label)

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56 participants in 2 patient groups

Albuterol/salbutamol followed by ipratropium

Active Comparator group

Description:

Subjects will recieve daily albuterol/salbutamol followed by ipratropium which will be adminstered one hour after adminstration of albuterol/salbutamol

Treatment:

Drug: Albuterol/salbutamol

Ipratropium followed by albuterol/salbutamol

Active Comparator group

Description:

Subjects will recieve daily ipratropium followed by albuterol/salbutamol which will be adminstered one hour after adminstration of ipratropium

Treatment:

Drug: Ipratropium