- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02822287
Warming Sensation and Tolerability Study of Acetylcysteine 2% Oral Solution for Productive Cough
December 5, 2016 updated by: GlaxoSmithKline
An Open Label Study to Assess the Warming Sensation, Acceptability and Local Oral Tolerability of NCH-GSK Acetylcysteine 2% Oral Solution, Given as a Single Dose in Subjects Suffering From Productive Cough Due to Upper Respiratory Tract Infection
This is a 1-treatment arm, open label design.
This 1-day study includes a screening on day of attendance at clinic, followed by a washout period of 30 minutes to 8 hours (if participants are eligible for dosing the same day).
The study also includes a supervised dosing with 10 mL oral solution and a 1 hour in-clinic evaluation period.
Study Overview
Study Type
Interventional
Enrollment (Actual)
58
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Thueringen
-
Erfurt, Thueringen, Germany, 99084
- GSK Investigational Site
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Participants must give written informed consent before any assessment is performed. In the case of adolescents Informed Consent must be signed by one or both parents or legal guardian as per local regulations and an Informed Assent must be signed by the participant.
- Must be males or females ≥ 12 years.
- Willingness and ability to communicate, to comply with all study requirements and to complete the study.
- Productive cough of less than 7 days duration, rated based on interview with the participant as mild to moderate severity on a four- point ordinal scale (not present, mild, moderate, severe) due to upper respiratory tract infection.
Exclusion Criteria:
- Use of other investigational drugs before enrollment, or within 30 days or 5 half-lives before enrollment, whichever is longer.
- Pre-dose productive cough or sore throat rated as severe on a four-point ordinal scale (not present, mild, moderate, severe) based on interview with the participant.
- Pre-dose temperature equal or above 39.4°C at screening measured by oral thermometer.
- History of hypersensitivity to any of the study drugs and the listed excipients or to drugs of similar chemical classes.
- Pregnant , nursing (lactating women) or women with child bearing potential UNLESS they are using effective methods of contraception.
- Use of any medication for sore throat containing a local anaesthetic, methanol or any topical products containing menthol, peppermint, spearmint or within the 6 hours prior to dosing.
- Use of any paracetamol, non-steroidal anti-inflammatory drug (NSAID) or any oral/nasal decongestant within 6 hours prior to dosing.
- Use of substances of abuse, herbal medications, or antihistamines within 48 hours of dosing.
- Hepatic or severe renal impairment, hypertension, hyperthyroidism, diabetes, or heart disease.
- Drinking of tea, coffee or other caffeinated beverages 1 hour prior to dosing.
- Drinking of any hot beverages 1 hour prior to dosing.
- Participant is a current smoker of ≥10 cigarettes per day (or reports equivalent smoking habits using other tobacco products) or smoked or chewed tobacco products within 12 hours before dosing.
- Participant is taking nitroglycerin and nitrate drug treatments.
- Participants who took antibiotic treatments such as semisynthetic penicillins, tetracyclines, cephalosporins and aminoglycosides within 2 hours of dosing. Amoxicillin, doxycycline, erythromycin, thiamphenicol and cefuroxime are allowed without this restriction.
- Participants with gastroduodenal (peptic) ulcers, asthma.
- Participants with intolerance to histamines.
- Participants who have used antitussives (e.g., dextromethorphan, codeine), anticholinergic drugs (atropine-like) within the past 24 hours.
- Participants who have taken heavy metal salts such as calcium, gold and iron within 2 hours of enrollment.
- A history of alcohol abuse or an admission by the participant that they regularly consume alcohol in excess of the recommended weekly limits of 21 units for females and 28 units for males.
- History of malignancy of any organ system (other than localized basal cell carcinoma of the skin), treated or untreated, within the past 5 years, regardless of whether there is evidence of local recurrence or metastases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: 2% Acetylcystine Solution
Participants will be orally administered with the clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle over 1 minute or less using an oral syringe.
|
Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Onset of Warming Sensation
Time Frame: 10 minutes post-dose
|
Onset and duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution.
First watch was stopped at the start of warming sensation and the second watch was stopped at the end.
If onset had not occurred by 10 minutes then time to onset was censored at 10 minutes.
53 of the 57 participants had onset within 10 minutes after dosing.
|
10 minutes post-dose
|
Duration of Warming Sensation
Time Frame: 10 minutes post-dose
|
Duration of action of warming sensation was measured by two stop watches started when the participants took the oral solution.
First watch was stopped at the start of warming sensation and the second watch was stopped at the end.
If onset of warming sensation occurred within 10 minutes of dosing but had not ended by the end of 10 minutes following dosing, then the duration was censored at 10 minutes minus the time to onset
|
10 minutes post-dose
|
Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose
Time Frame: Pre-dose and 60 sec post-dose
|
Warming Sensation Intensity was measured on 100 mm visual analogue scale (VAS), marked as "no warming sensation" on the left hand side (= 0 mm) and "strongest possible warming sensation" at the right hand side (=100 mm) at pre-dose.
|
Pre-dose and 60 sec post-dose
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Participants With Acceptability of Warming Sensation
Time Frame: 10 minutes post-dose
|
Acceptability of strength of warming sensation was measured by a scale: 5= Much too strong; 4=Too strong (too warming); 3= Just about right (pleasant warming); 2= Too weak (not warming enough); 1= Much too weak
|
10 minutes post-dose
|
Number of Participants With Overall Opinion of Warming Sensation
Time Frame: 10 minutes post-dose
|
Overall opinion of warming sensation was measured by scale: 9= Like extremely; 8= Like very much; 7= Like moderately; 6= Like slightly; 5= Neither like nor dislike; 4= Dislike slightly; 3= Dislike moderately; 2= Dislike very much; 1= Dislike extremely
|
10 minutes post-dose
|
Number of Participants With Overall Opinion of Oral Solution
Time Frame: 1 hour post-dose
|
Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.
|
1 hour post-dose
|
Local Oral Tolerability
Time Frame: Day 1 (at screening and end of study)
|
Local oral tolerability was assessed by performing oropharyngeal examination as follows: Results of oropharyngeal examination (Normal and abnormal); If abnormal, any signs of lesion on oral mucosa or irritation of oral mucosa.
|
Day 1 (at screening and end of study)
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2016
Primary Completion (Actual)
March 1, 2016
Study Completion (Actual)
March 1, 2016
Study Registration Dates
First Submitted
February 11, 2016
First Submitted That Met QC Criteria
June 29, 2016
First Posted (Estimate)
July 4, 2016
Study Record Updates
Last Update Posted (Estimate)
January 31, 2017
Last Update Submitted That Met QC Criteria
December 5, 2016
Last Verified
September 1, 2016
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 205034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Common Cold
-
Cardiff UniversityCompletedCommon Cold/FluUnited Kingdom
-
Perrigo CompanyGlaxoSmithKline; Pfizer; McNeil Consumer Healthcare Division of McNEIL-PPC, Inc. and other collaboratorsCompletedNasal Congestion Associated With the Common ColdUnited States
-
NovartisCompletedCommon Cold Associated With CoughCanada
-
Probi ABCompletedAcute Upper Respiratory Tract Infections (Common Cold)Italy
-
Ache Laboratorios Farmaceuticos S.A.Suspended
-
Beijing Da-an Bio-technology Co., Ltd.Unknown
-
Brainfarma Industria Química e Farmacêutica S/ATechtrials Pesquisa e Tecnologia Ltda; PharmagenixUnknown
-
NovartisCompletedSore Throat Due to a Common ColdGermany
-
Boehringer IngelheimCompleted
-
Lund UniversityCoradil ABEnrolling by invitation
Clinical Trials on Acetylcystine
-
University of California, San FranciscoTerminated
-
University of California, San FranciscoRecruiting
-
Assiut UniversityNot yet recruitingThalassemia Major
-
Tel-Aviv Sourasky Medical CenterUnknown
-
Royal Alexandra HospitalUniversity of Alberta; Gambro Renal Products, Inc.CompletedRhabdomyolysisCanada, Saudi Arabia
-
William StoopsNational Institute on Drug Abuse (NIDA)RecruitingOpioid Use Disorder | Cocaine Use DisorderUnited States
-
University of California, San FranciscoNational Heart, Lung, and Blood Institute (NHLBI)RecruitingAsthma | COPDUnited States