Clinical Trial of NAC in Asthma

Asthma Clinical Trial

— CONA  

Official title:

Clinical Trial of NAC in Asthma

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02605824
• Other study ID #: 15-17919
• Status: Terminated
• Phase: Phase 4
• Start date: March 2016
• Est. completion date: December 2017

Study information

• Verified date: July 2019
• Source: University of California, San Francisco
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This study evaluates 20% n-acetylcystine (NAC) in the treatment of moderate-to-severe asthma that is complicated by mucus in the airway, as determined by CT imaging. The study is a crossover design, which means that half the study participants will get 20% NAC in the first 7-day treatment period and placebo in the next 7-day treatment period; and the other half will get placebo in the first 7-day treatment period and 20% NAC in the next 7-day treatment period.

Description:

n-acetylcystine (NAC) is a mucolytic medication, meaning that it breaks apart mucus. Investigators know that mucus is a factor in severe asthma attacks. However, mucus may be a factor in chronic severe asthma as well. This role has been hard to prove because of difficulty in showing that mucus occludes the lumen in chronic severe disease. Using a novel approach of scoring mucus occlusion, investigators have used CT imaging to uncover that a majority of people with severe asthma have at least one lung segment with a mucus plug and 27% have more than four lung segments with mucus plugs.

Historically, studies of mucolytics, like NAC, have not shown benefit in other obstructive lung diseases, like COPD. However, utilizing CT mucus scores as a biomarker, investigators believe that mucolytic treatment may prove useful for those with significant mucus impaction.

This is a randomized, double-blind, placebo-controlled phase 4 study of 20% NAC in patients with asthma who also have evidence of mucus in their lungs as determined by CT imaging. Investigators hypothesize that by treating asthmatics, chosen based on the presence of mucus in the airways, with a mucolytic like NAC, will result in an improvement of lung function.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Able to perform reproducible spirometry according to ATS criteria

• Clinical history consistent with moderate to severe asthma for 1 year or greater.

• Post-bronchodilator FEV1 <90% of predicted

• Prescription and daily use of inhaled corticosteroid (ICS) equivalent to 240mcg of beclomethasone or greater and a second asthma controller therapy.

• CT mucus score >3 (determined during the initial screening process, provided the prior two conditions are met)

• Written informed consent obtained from participant and ability for participant to comply with the requirements of the study.

Exclusion Criteria:

• Pregnant, breastfeeding, or unwilling to practice birth control during participation in the study.

• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

• History of intolerance to study medications.

• Current use of carbamazepine

• Angina which includes a treatment plan with PRN nitroglycerin or nitrites

• Smoking of tobacco or other recreational inhalants in last year and/or >10 pack-year smoking history

• Current participation in an investigational drug trial Concurrent Medications

Related Conditions & MeSH terms

• Asthma

Intervention

Drug:
• n-acetylcystine
NAC is a mucolytic drug.
• 0.9% saline
Normal saline is a placebo agent.

Locations

Country	Name	City	State
United States	UCSF Airway Clinical Research Center	San Francisco	California

Sponsors (1)

Lead Sponsor	Collaborator
University of California, San Francisco

Country where clinical trial is conducted

United States, 

References & Publications (2)

DUNNILL MS. The pathology of asthma, with special reference to changes in the bronchial mucosa. J Clin Pathol. 1960 Jan;13:27-33. — View Citation

Hays SR, Fahy JV. The role of mucus in fatal asthma. Am J Med. 2003 Jul;115(1):68-9. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Post-bronchodilator FEV1 (L)	This is a measure of forced expiratory volume measured in one second, following the administration of 4 puffs of albuterol. This outcome will compare the change in post-bronchodilator FEV1 (L) both before and after treatment.	7 days
Secondary	Change CT Mucus Score	The CT Mucus Score describes the number of segments of the lungs that are impacted by mucus. This outcome will compare the change in CT mucus score both at baseline and following each treatment period.	7 days

External Links

•   Study Center Website