Latte 2007.

Methods	Randomised, double‐blind, placebo‐controlled, parallel‐group study
Participants	N recruited: 216 N analysed: ‐ Placebo: N = 105 ‐ Pseudoephedrine: N = 107 212 had complete data on visit 1 210 had complete data on visit 2 211 completed treatment on day 3 It is not indicated how many participants of the treatment group or placebo group had complete data on day 2 and 3 Age: 18 to 65 years Country: Australia Inclusion criteria: Nasal congestion due to the common cold Male and female Aged 18 to 65 years Good general health Suffering from common cold <= 48 hours Exclusion criteria: Women who were pregnant or lactating, or not using an appropriate form of contraception History of perennial allergic rhinitis Unstable medication Diagnostic criteria: episode of common cold no more than 48 hours duration before visit 1
Interventions	Nasal decongestant dose: Pseudoephedrine 60 mg Placebo Administration: multiple doses Oral tablets; 1 tablet 4 times a day for 4 days Follow‐up: 4 days Measurements: Total nasal airways resistance was measured using the posterior rhinomanometry technique Total nasal volume and total minimum cross‐sectional area were measured using acoustic rhinometry A 100 mm visual analogue scale from 0 mm to 100 mm was used to assess symptoms of nasal congestion Subjective measurements on a 7‐point categorical scale for the previous 24 hours (0 none to 6 incapacitating) ‐ worst levels of congestion ‐ worst levels of nasal discharge ‐ worst levels of sneezing Measurements were performed hourly (for 4 hours) after the first dose on day 1 and after the last dose on day 4
Outcomes	Primary outcome: the area under the logarithm‐transformed total nasal airways resistance curve from 0.5 to 3 hours after the first dose of study medication on day 1 Secondary outcomes: The area under the curve for the total minimum cross‐sectional area of the combined left and right nasal cavities from 0 to 3 hours on day 1 and 3 The area under the curve for the total nasal volume of the combined left and right nasal cavities from 0 to 3 hours on day 1 and 3 The area under the curve for the nasal congestion visual analogue scale from 0 to 3 hours on day 1 and 3
Notes	Funding: Pfizer Consumer Health Care Declarations of interest: not provided
Risk of bias
Bias	Authors' judgement	Support for judgement
Random sequence generation (selection bias)	Low risk	A randomisation schedule was used: "Medication was allocated blindly according to a centrally generated randomisation code"
Allocation concealment (selection bias)	Unclear risk	Study reports that "medication was allocated blindly", but method of allocation concealment not clearly stated. Only that "subjects were given treatments consisting of either active medication […] or matching placebo". However, it is not clear if participants could not foresee assignment
Blinding of participants and personnel (performance bias) All outcomes	Unclear risk	Study reports that it was double‐blind, but methods of blinding not reported
Blinding of outcome assessment (detection bias) All outcomes	Unclear risk	Study reports that it was double‐blind, but there is no mention of method of blinding outcome assessment
Incomplete outcome data (attrition bias) All outcomes	Unclear risk	There are 6 dropouts throughout the study, but only 1 discontinuation is explained in the text. The number of remaining participants in each treatment group is not clear
Selective reporting (reporting bias)	Low risk	All intended outcomes reported
Other bias	Unclear risk	Study supported by Pfizer Consumer Health Care