Common ColdPhase 3NCT02822287

Warming Sensation and Tolerability Study of Acetylcysteine 2% Oral Solution for Productive Cough

A Phase 3 study testing Acetylcystine in people with Common Cold, run by GlaxoSmithKline at 1 site in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial summary

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). Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Common Cold
What is being tested?: Acetylcystine
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 58 participants
Where: 1 siteGermany
Study dates: Feb 2016to Mar 2016
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Show all 20Show fewer

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.

Trial locations and contacts

1 site in 1 country.

Germany1 site

GSK Investigational Site
Erfurt, Thuringia, 99084

Other trials in Germany

About this study

Official title: 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

Conditions: Common Cold
Being tested: Acetylcystine
Medical subject headings: Common Cold

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

AcetylcystineDrug
Clear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.

Study groups in NCT02822287
Study group	Role	What they receive
2% Acetylcystine Solution	Experimental	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. Receives: Drug: Acetylcystine

What is being measured

The primary outcome is the main question the study is designed to answer.

Onset of Warming Sensation
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.
Measured: 10 minutes post-dose
Duration of Warming Sensation
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
Measured: 10 minutes post-dose
Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) 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.
Measured: Pre-dose and 60 sec post-dose

Secondary outcomes (4)

Number of Participants With Acceptability of Warming Sensation
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
Measured: 10 minutes post-dose
Number of Participants With Overall Opinion of Warming Sensation
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
Measured: 10 minutes post-dose
Number of Participants With Overall Opinion of Oral Solution
Overall opinion of oral solution was measured by scale: 4 = Excellent; 3 = Good; 2 = Fair; 1 = Poor; 0 = Unacceptable.
Measured: 1 hour post-dose
Local Oral Tolerability
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.
Measured: Day 1 (at screening and end of study)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016Mar 2016

First posted4 Jul 2016 (estimated)
Study startFeb 2016
Primary completionMar 2016
Study completionMar 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Common ColdStudies of the same condition, open and under way.
More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 58 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02822287
Sponsor's protocol ID: 205034
Status last verified: Sep 2016
First submitted: 11 Feb 2016
Last updated: 31 Jan 2017
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Common Cold trials

Study at a glance

From the registry record, last updated by the sponsor on 31 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: 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
ClinicalTrials.gov ID: NCT02822287
Acronym / sponsor ID: 205034
Conditions: Common Cold
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 58 participants (actual)
Lead sponsor: GlaxoSmithKlineIndustry (pharma, biotech, devices)
Study start: Feb 2016
Primary completion: Mar 2016 (actual)
Study completion: Mar 2016 (actual)
First posted: 4 Jul 2016 (estimated)
Results: Posted 31 Jan 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
2% Acetylcystine Solution	Experimental	Drug: AcetylcystineParticipants 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.

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (20 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
AcetylcystineClear oral solution containing 2% acetylcysteine (g/mL) in a 100 mL amber glass bottle.	Drug	2% Acetylcystine Solution

Primary outcome

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.
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
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.

4 secondary outcomes

Number of Participants With Acceptability of Warming Sensation
Time frame: 10 minutes post-dose
Number of Participants With Overall Opinion of Warming Sensation
Time frame: 10 minutes post-dose
Number of Participants With Overall Opinion of Oral Solution
Time frame: 1 hour post-dose
Local Oral Tolerability
Time frame: Day 1 (at screening and end of study)

Results and safety

Results posted to the registry on 31 Jan 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
2% Acetylcystine Solution	57	57

Primary outcome: Onset of Warming Sensation

Time frame: 10 minutes post-dose. Median (Full Range). Unit: Minutes

Measure	2% Acetylcystine Solution n = 57
Value	0.233 (0.067 to 10.00)

Population analysed: The Safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint analyses and the safety analysis.

Primary outcome: Duration of Warming Sensation

Time frame: 10 minutes post-dose. Median (Full Range). Unit: Minutes

Measure	2% Acetylcystine Solution n = 53
Value	2.833 (0.150 to 9.783)

Population analysed: The safety Population was defined as all treated subjects, i.e., all subjects who received any dose of study drug. The Safety Population was the primary population for both the primary and secondary endpoint and safety analysis. Of the 57 subjects in the Safety Population, 53 reported an onset of a warming sensation within10 minutes after dosing.

Primary outcome: Warming Sensation Intensity at Pre-Dose and 60 Sec (Seconds) Post-Dose

Time frame: Pre-dose and 60 sec post-dose. Mean (Standard Deviation). Unit: Millimeters (mm)

Measure	2% Acetylcystine Solution n = 57
Pre-dose	6.8 (8.69)
Post-dose (Observed)	36.1 (26.93)
Post-dose (Change)	29.2 (27.84)

4 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
2% Acetylcystine Solution	0 of 57 (0%)	0 of 57 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2017.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

Related trials for Common Cold

Recruiting
Probiotic Trial for URTI Prevention in Healthy Adults
Upper Respiratory Tract Infections
Not yet recruiting
Enhanced Telemedicine in Primary Care for Acute Respiratory Tract Infections Study
Acute Respiratory Tract Infection, Ear Infection
Not yet recruitingObservational study
Post-market Clinical Follow-up Study of an Isotonic Saline Solution for the Relief of Nasal Congestion in Infants and Toddlers
Nasal Congestion, Common Cold
Recruiting
Effect of Immune X on Common Cold Incidence in Healthy Adults
Common Cold, Upper Respiratory Tract Infection (URTI)
Recruiting
Omega-Cold Supplementation With Free Fatty Acids for the Prevention of Respiratory Infections in Adults.
Respiratory Infections

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

GSK Clinical Trials study director

GlaxoSmithKline

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Acetylcystine in people with Common Cold, run by GlaxoSmithKline at 1 site in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 31 Jan 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Onset of Warming Sensation (time frame: 10 minutes post-dose). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02822287.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2017.