Ultra-long Acting Bronchodilator Therapy in Smoking Asthmatics

Asthma Clinical Trial

— MAN05  

Official title:

Effects of Ultra-long Acting Bronchodilator Therapy Assessed by Impulse Oscillometry in Smoking Asthmatics Taking Inhaled Corticosteroids

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02682862
• Other study ID #: 2013RC06
• Secondary ID: 2014-005317-23
• Status: Completed
• Phase: Phase 4
• Start date: July 11, 2016
• Est. completion date: May 22, 2019

Study information

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

Clinical Trial Summary

Single centre, open-label, random order, cross-over trial, recruited over a period of approximately 2 years. Sufficient participants enrolled to complete 16 adults. Withdrawn subjects may be replaced.

This clinical trial will assess the effects of ultra-long acting bronchodilator therapy in smoking asthmatics taking inhaled corticosteroids. This will be via a pulmonary function test called impulse oscillometry.

Description:

Cigarette smoking in asthma is associated with poorer asthma control and a higher frequency of asthma attacks. Despite this, smoking cessation rates are very low due to the highly addictive nature of tobacco smoking. Asthma in smokers is particularly challenging to manage because it is resistant to the beneficial effects of inhaled corticosteroids, the main treatment for asthma.

Unfortunately, there is no guideline consensus regarding how to best manage asthmatics who smoke. Research studies in asthma tend to exclude smokers because of concerns about recruiting patients with chronic obstructive pulmonary disease (COPD). Hence, there is an unmet need for research studies in asthmatics who are unable to stop smoking.

In view of the above, we propose to assess the effects of two different types of bronchodilators (inhalers which help open up the airways), in asthmatics who continue to smoke.

Participants will receive both of the following drugs for 2-4 weeks in random order, with a 2-3 week washout period in between:

Olodaterol which is a new long-acting bronchodilator. Olodaterol combined with tiotropium (dual bronchodilators). We wish to compare these inhalers using a sensitive pulmonary function test called impulse oscillometry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 17
• Est. completion date: May 22, 2019
• Est. primary completion date: May 22, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Male or female volunteers aged 18-65 years with persistent asthma and on inhaled corticosteroids (at least 400 micrograms beclomethasone dipropionate equivalent dose daily)

• Current smoker

• Forced Expiratory Volume in 1 second (FEV1) = 60 % predicted

• 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 significant respiratory diseases, in the opinion of the investigator, such as COPD or bronchiectasis.

• An asthma exacerbation or respiratory tract infection requiring systemic steroids and/or antibiotics within 1 month of the study commencement or 3 months if hospital admission was required

• Any clinically significant medical condition that may endanger the health or safety of the participant

• Participation in another drug trial within 30 days before the commencement of the study

• Pregnancy or lactation

• Unable to comply with the procedures of the protocol

• Unable or unwilling to consent

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• olodaterol hydrochloride 2.5mcg, tiotropium bromide 2.5mcg
Inhaler: 2.5 microgram tiotropium (as bromide monohydrate) and 2.5 microgram olodaterol (as hydrochloride) per puff. 2 puffs once daily
• olodaterol 2.5 mcg
Inhaler: 2.5 microgram Olodaterol (as hydrochloride) per puff. 2 puffs once daily

Locations

Country	Name	City	State
United Kingdom	Scottish Centre for Respiratory Research, University of Dundee, Ninewells Hospital and Medical School	Dundee	Scotland

Sponsors (1)

Lead Sponsor	Collaborator
University of Dundee

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Airway resistance at 5Hz (R5)	measured by Impulse oscillometry (IOS)	2-4 weeks
Secondary	RF	Impulse Oscillometry: Resonant Frequency	2-4 weeks
Secondary	X5	Impulse Oscillometry: Reactance at 5Hz	2-4 weeks
Secondary	AX	Impulse Oscillometry: Reactance Area	2-4 weeks
Secondary	R5-R20	Impulse Oscillometry: Resistance at 5Hz minus Resistance at 20Hz, equating to small airway resistance	2-4 weeks
Secondary	R20	Impulse Oscillometry: Resistance at 20Hz	2-4 weeks
Secondary	FEF25-75 pre and post challenge	Spirometry: Forced expiratory flow 25%-75% pre and post bronchial challenge (assessing change)	2-4 weeks
Secondary	FVC pre and post challenge	Spirometry: Forced vital capacity pre and post bronchial challenge (assessing change)	2-4 weeks
Secondary	FEV1 pre and post challenge	Spirometry: Forced expiratory volume in 1 second pre and post bronchial challenge (assessing change)	2-4 weeks
Secondary	Mannitol PD30	Provocation dose of mannitol causing 30% increase in R5	2-4 weeks
Secondary	Mannitol RDR	Response-Dose Ratio	2-4 weeks
Secondary	R5 at PD30	Airway Resistance at 5 Hertz at PD30	2-4 weeks
Secondary	Salbutamol recovery time following mannitol challenge		2-4 weeks
Secondary	Domiciliary PEF	Peak Expiratory Flow	2-4 weeks
Secondary	ACQ	Asthma Control Questionnaire	2-4 weeks