Clinical trial NCT02039050: Evaluation of Long-Acting Muscarinic Antagonists in COPD
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Pulmonary Disease, Chronic Obstructive
Keywords: Pulmonary Disease, Chronic Obstructive
Long-acting muscarinic antagonists
Impulse oscillometry
Lead sponsor: University of Dundee
Sponsor class: OTHER
Collaborators: name: Almirall Limited
First posted: 2014-01-17
Enrollment: 15
Sex: ALL
Minimum age (years): 40
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

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


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

Primary outcomes:
measure: Change in trough R5 from baseline after chronic dosing
timeFrame: 4 to 6 weeks
Secondary outcomes:
measure: Remaining impulse oscillometry (IOS) variables (R20,R5-R20,X5,AX,RF)
timeFrame: 4 to 6 weeks
measure: Spirometry (FEV1, FEF25-75, FVC)
timeFrame: 4 to 6 weeks
measure: Relaxed VC (RVC) with RVC to FVC ratio
timeFrame: 4 to 6 weeks
measure: Six-minute walk test (includes oxygen saturation measurements and Borg dyspnoea score)
timeFrame: 4 to 6 weeks
measure: Domiciliary PIKO-6 measurements for FEV1 and FEV6
timeFrame: 4 to 6 weeks
measure: St. George's Respiratory Questionnaire (SGRQ)
timeFrame: 4 to 6 weeks
measure: Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI)
timeFrame: 4 to 6 weeks
Other outcomes:
Locations:
city: Dundee
country: United Kingdom
facility: Asthma and Allergy Research Group, University of Dundee
Study officials:
affiliation: University of Dundee
name: Brina Lipworth, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Dundee
name: Arvind Deva Manoharan, MBChB
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.