Evaluation of Long-Acting Muscarinic Antagonists in COPD

Pulmonary Disease, Chronic Obstructive Clinical Trial

— MAN04  

Official title:

Proof of Concept Evaluation of Drug-Device Interaction With Aclidinium Bromide Via Genuair® and Tiotropium Bromide Via HandiHaler® in COPD Using Impulse Oscillometry

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02039050
• Other study ID #: 2013RC09
• Status: Completed
• Phase: Phase 4
• Start date: February 2014
• Est. completion date: July 2015

Study information

• Verified date: April 2019
• Source: University of Dundee
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Disease
• Lung Diseases
• Pulmonary Disease, Chronic Obstructive

Intervention

Drug:
• Tiotropium

• Aclidinium

Locations

Country	Name	City	State
United Kingdom	Asthma and Allergy Research Group, University of Dundee	Dundee

Sponsors (2)

Lead Sponsor	Collaborator
University of Dundee	Almirall Limited

Country where clinical trial is conducted

United Kingdom, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in trough R5 from baseline after chronic dosing		4 to 6 weeks
Secondary	Remaining impulse oscillometry (IOS) variables (R20,R5-R20,X5,AX,RF)		4 to 6 weeks
Secondary	Spirometry (FEV1, FEF25-75, FVC)		4 to 6 weeks
Secondary	Relaxed VC (RVC) with RVC to FVC ratio		4 to 6 weeks
Secondary	Six-minute walk test (includes oxygen saturation measurements and Borg dyspnoea score)		4 to 6 weeks
Secondary	Domiciliary PIKO-6 measurements for FEV1 and FEV6		4 to 6 weeks
Secondary	St. George's Respiratory Questionnaire (SGRQ)		4 to 6 weeks
Secondary	Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI)		4 to 6 weeks