MAN04: Evaluation of Long-Acting Muscarinic Antagonists in COPD

Sponsor

University of Dundee (Other)

Overall Status

Completed

CT.gov ID

NCT02039050

Collaborator

Almirall Limited (Other)

Enrollment

Location

Arms

16.9

Duration (Months)

0.9

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Pulmonary Disease, Chronic Obstructive	Drug: Tiotropium Drug: Aclidinium	Phase 4

Study Design

Study Type:

Interventional

Actual Enrollment :

15 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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 Start Date :

Feb 1, 2014

Actual Primary Completion Date :

Jul 1, 2015

Actual Study Completion Date :

Jul 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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.	Drug: Tiotropium
Experimental: 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.	Drug: Aclidinium

Arm

Intervention/Treatment

Active Comparator: 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.

Drug: Tiotropium

Experimental: 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.

Drug: Aclidinium

Outcome Measures

Primary Outcome Measures

Change in trough R5 from baseline after chronic dosing [4 to 6 weeks]

Secondary Outcome Measures

Remaining impulse oscillometry (IOS) variables (R20,R5-R20,X5,AX,RF) [4 to 6 weeks]
Spirometry (FEV1, FEF25-75, FVC) [4 to 6 weeks]
Relaxed VC (RVC) with RVC to FVC ratio [4 to 6 weeks]
Six-minute walk test (includes oxygen saturation measurements and Borg dyspnoea score) [4 to 6 weeks]
Domiciliary PIKO-6 measurements for FEV1 and FEV6 [4 to 6 weeks]
St. George's Respiratory Questionnaire (SGRQ) [4 to 6 weeks]
Baseline Dyspnea Index-Transition Dyspnea Index (BDI-TDI) [4 to 6 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

40 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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