Evaluation of Long-Acting Muscarinic Antagonists in COPD

NCT ID: NCT02039050

Last Updated: 2019-04-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 15 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-02-28
• Study Completion Date: 2015-07-31

Brief Summary

In chronic obstructive pulmonary disease (COPD), the airways of the lungs are narrowed or blocked. Bronchodilators are drugs usually delivered through inhalers which help open up the airways. Tiotropium is a type of bronchodilator drug known as a long-acting muscarinic antagonist (LAMA). For a long time tiotropium was the only available LAMA. More recently, a new LAMA called aclidinium has been approved for use in COPD. There are potentially important differences between these two medications that might have an impact on the treatment of COPD patients.

In this study we aim to compare the effects of tiotropium and aclidinium in people with COPD. The main comparison will be done using a very sensitive breathing test called impulse oscillometry

Conditions

Pulmonary Disease, Chronic Obstructive

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Tiotropium

Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.

Group Type: ACTIVE_COMPARATOR

Tiotropium

Intervention Type: DRUG

Aclidinium

Participants receive tiotropium for 2 to 3 weeks.Participants then enter a washout period and after the washout period receive the alternative treatment arm.

Group Type: EXPERIMENTAL

Aclidinium

Intervention Type: DRUG

Interventions

Tiotropium

Intervention Type: DRUG

Aclidinium

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Male and female volunteers aged 40-80 years with moderate to severe COPD (GOLD Stage 2, 3).
• On inhaled corticosteroids / long-acting beta agonists
• FEV1 30-80% predicted and FEV1/FVC <70%.
• Smoking history ≥10 pack-years.
• Ability to give informed consent
• Agreement for their General Practitioner to be made aware of study participation and to receive feedback as relevant to the participant's well being

Exclusion Criteria

• Other respiratory diseases such as asthma, bronchiectasis or allergic bronchopulmonary aspergillosis
• A COPD exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement (3 months if hospitalisation has been required)
• Any clinically significant medical condition that may endanger the health or safety of the participant
• Known or suspected sensitivity to/intolerance of investigational medicinal product
• Patients with prostatic hyperplasia, bladder outflow obstruction or glaucoma
• Pregnancy or lactation
• Unable to comply with the procedures of the protocol

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Almirall Limited

UNKNOWN

Sponsor Role: collaborator

University of Dundee

OTHER

Sponsor Role: lead

Responsible Party

Brian J Lipworth

Professor of Allergy and Pulmonology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Brina Lipworth, MD

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Arvind Deva Manoharan, MBChB

Role: PRINCIPAL_INVESTIGATOR

University of Dundee

Locations

Asthma and Allergy Research Group, University of Dundee

Dundee, , United Kingdom

Countries

United Kingdom

References

Manoharan A, Morrison AE, Lipworth BJ. Effects of Adding Tiotropium or Aclidinium as Triple Therapy Using Impulse Oscillometry in COPD. Lung. 2016 Apr;194(2):259-66. doi: 10.1007/s00408-015-9839-y. Epub 2016 Jan 13.

Reference Type: RESULT

PMID: 26758884 (View on PubMed)

Other Identifiers

2013RC09

Identifier Type: -

Identifier Source: org_study_id