Skip to main content
. 2023 Jun 14;2023(6):CD001506. doi: 10.1002/14651858.CD001506.pub5

Gupta 2012.

Study characteristics
Methods RCT.
Design: double‐blind, parallel design
Duration: 28 days.
Location: single‐centre study conducted in India.
Participants Children with CF (diagnosed based on 2 abnormal sweat test results (sweat chloride > 60 mEq) in the presence of suggestive clinical features) who are being followed up in clinic, aged between 6 and 16 years.
36 assessed for eligibility
31 randomised, 30 participants analysed (1 participant lost to follow‐up).
Age, mean (SD): 3% HS group 10.6 (2.87) years; 7% HS group 10.87 (3.64) years.
Sex: 3% HS group, 9 male (60%) and 6 female (40%); 7% HS group 13 male (86.67%) and 2 female (13.33%).
CF mutation homozygous delta F508: 3% HS 3 (20%); 7% HS 1 (6.67%).
CF mutation heterozygous mutation: 3% HS 0 (0%); 7% HS 2 (13.33%).
Other CF mutations: 3% HS 9 (60.00%); 7% HS 7 (46.67%).
Mutation analysis not done: 3% HS 3 (20%); 7% HS 5 (33.33%).
FEV1 % predicted, mean (SD): 3% HS 50.2% (20.28); 7% HS 57.87% (26.93).
FVC % predicted, mean (SD): 3% HS 55.07 (13.69); 7% HS 60.33 (22.84).
Interventions Intervention: sterile 7% HS.
Comparator: sterile 3% HS.
Both solutions were made available in transparent collapsible bags of equal volume.
Solutions were prepared by the Department of Pharmacology, All India Institute of Medical Sciences, with technical assistance from Baxter Pharmaceuticals Limited as per Good Manufacturing Practices guidelines, using Indian Pharmacopeia grade sodium chloride and sterile, double‐distilled water.
Inhalation of 5 mL of the test drug, after taking a bronchodilator, twice a day by a jet nebuliser for 28 days.
Outcomes Primary outcome
Improvement in FEV1 (absolute % predicted)
Secondary outcome

  1. Improvement in FVC

  2. Functional capacity (3‐min step test)

  3. PEFR

  4. Oxygen saturation

  5. Heart rate

  6. VAS 15‐count score, pre‐ and post‐ 3‐min step test
Notes Sample size calculation was carried out and with less than 10% difference, 5% error and power of 80%, the required number of participants was 394. This sample size was not possible and so a pilot study with 15 participants in each group was carried out.
Risk of bias
Bias Authors' judgement Support for judgement
Random sequence generation (selection bias) Low risk The random sequence was generated using a computer program by a person not involved in the trial.
Allocation concealment (selection bias) Low risk The intervention solutions were sequentially numbered as per the randomisation list by another person not involved in the trial.
Blinding of participants and personnel (performance bias)
All outcomes Low risk Participants and investigators were blinded. The collapsible bags were similar in appearance and taste was not discernable.
Blinding of outcome assessment (detection bias)
All outcomes Low risk Outcome assessors were blinded.
Incomplete outcome data (attrition bias)
All outcomes Low risk 31 participants were randomised and there was only 1 lost to follow‐up in the 3% HS group. This meant that there were 15 in each arm and all of these participants were followed up.
Selective reporting (reporting bias) Unclear risk In the methods the authors say that they will be measuring adherence by the return of unused saline and keeping a diary but these are not mentioned in the results.
Other bias Unclear risk A sample size calculation was carried out with an alpha error of 5% and power of 80% which estimated that a sample size of 394 was needed. This was not possible and so the authors conducted a pilot study instead.