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

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
58

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Germany
    • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
Drug: Acetylcystine
Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 1, 2016

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 11, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
July 4, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 31, 2017

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 5, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

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